YEAR-END REPORT - 2019 Published 23-Dec-2019 HPTS Issue Brief 12-23-19.34 Health Policy Tracking Service - Issue Briefs Pharmaceuticals and Medical Devices Cost Savings Authored by David J. Steiner, J.D., a contributing writer and member of the Ohio bar. 12/23/2019 I. Introduction New York Congressman Joe Morelle recently introduced legislation intended to address and reverse the increasing costs of prescription drugs. The Lower Drug Costs Now Act (H.R. 3) attempts to “help ensure life-saving medication is accessible and affordable for all people, especially seniors and those with low or fixed incomes.” California Governor Gavin Newsom recently signed into law two bills intended to lower the cost of prescription drugs. These bills aim to prevent pharmaceutical companies from keeping cheaper generic medicine off the market and expand access to PrEP and PEP HIV medication. New York Congressman Anthony Brindisi, along with Reps. Scott Peters (CA-52) and Pete King (NY-02), recently introduced the bipartisan Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act. The legislation is intended to eliminate a patient's copay for a biosimilar drug if they normally would pay full cost of a biologic drug under Medicare Part B. The U.S. House of Representatives recently unanimously voted to pass H.R. 2115, Public Disclosure of Drug Discounts Act. The bill would require Pharmacy Benefit Managers (PBMs) to report their aggregate rebates, discounts, and other price concessions for prescription drugs to a public website, allowing consumers, employers, and other payers to understand and compare the discounts PBMs receive. The American College of Physicians (ACP) recently released policy papers calling for changes that would address rising prescription drug costs. II. General cost saving news Drug maker advocacy group files 301 Report with government addressing perceived issues in foreign markets potentially affecting prices The Pharmaceutical Research and Manufacturers of America (PhRMA) recently urged the Office of the United States Trade Representative (USTR) to take immediate action to address what PhRMA believes to be “serious and growing market access and intellectual property barriers in top overseas markets.” PhRMA represents many of the country's leading innovative biopharmaceutical research companies, which, according to the organization, “are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives.” In its submission for USTR's annual Special 301 Report, PhRMA called on the Trump administration to name Canada, Japan, Korea and Malaysia as “Priority Foreign Countries.” This designation is reserved for countries with the worst market access barriers and the most damaging intellectual property practices. The annual Special 301 Report, which is required by the Trade Act of 1974, identifies foreign countries that deny adequate and effective intellectual property protection or fair and equitable market access for U.S. products. According to PhRMA Senior Vice President for International Advocacy Brian Toohey, “When foreign countries impose trade barriers and fail to value new inventions, they threaten U.S. manufacturing and jobs. Damaging price controls in Canada, Japan, Korea and many other countries are jeopardizing American exports and limiting access to new medicines.” © 2020 Thomson Reuters. No claim to original U.S. Government Works. -1- PhRMA's submission lists foreign government price-setting practices in these countries and others that allegedly limit access to medicines developed in the United States and undermine investment in new treatments for Alzheimer's, cancer and other diseases. PhRMA's position is that ending these policies could add billions of dollars to R&D and reduce overall health care costs worldwide. Mr. Toohey further noted that, “American patients should not have to shoulder the burden of paying for global innovation. The United States must use all available tools in negotiations with foreign countries to open overseas markets and level the playing field for American biopharmaceutical innovators and the 4.7 million jobs they support across the country. The U.S.-Mexico-Canada Agreement was a significant step forward in raising standards across North America. We encourage USTR to accomplish similar goals during upcoming international negotiations.” PhRMA also listed countries such as Malaysia, Indonesia, Chile, and Colombia as threatening to break patents on new medicines. According to PhRMA, this action, also known as “compulsory licensing,” creates significant uncertainty for biopharmaceutical innovators and allegedly harms patients by undermining incentives for future research. Toohey also stated that, “Malaysia and other governments are trying to benefit their own domestic companies by expropriating American inventions. America's trade negotiators must promote effective intellectual property protection and enforcement abroad and ensure compulsory licensing does not become a tool for national industrial policy.” PhRMA's Special 301 submission requests the USTR to take urgent action to address concerns in the following countries: • Canada: Despite progress on strengthening IP protections through the successful conclusion of the U.S.-Mexico-Canada Agreement (USMCA), proposed pricing regulations on patented medicines in Canada would significantly undermine the practical benefits of Canada's trade-related commitments and create uncertainty for patients. • Japan: New pricing regulations covering patented medicines – including premium pricing rules and flawed health technology assessments –inappropriately target products developed outside Japan for price cuts and are out of line with international norms and best practices. These rules are being developed with little stakeholder engagement or transparency and significantly erode the appropriate value for U.S. intellectual property. • Korea: Following new commitments made during the U.S.-Korea Free Trade Agreement (KORUS) renegotiation, Korea has continued to severely devalue innovative medicines developed by U.S. companies, contrary to its KORUS obligations and the spirit of the renegotiation. • Malaysia: The Malaysian government granted a compulsory license for the patent protecting an innovative U.S. medicine. This unjustified and unwarranted action undermines the innovation ecosystem that leads to lifesaving discovery. [FN1] PhRMA also requested that USTR include Chile, Colombia, Indonesia and 11 other countries on the “Priority Watch List”. Cigna and Express Scripts announce cap on out-of-pocket costs for insulin of $25 for a 30-day supply Global health service company Cigna and Express Scripts recently announced the launch of the Patient Assurance Program, which will ensure eligible people with diabetes in participating plans pay no more than $25 for a 30-day supply of insulin. According to Steve Miller, M.D., executive vice president and chief clinical officer, Cigna “For people with diabetes, insulin can be as essential as air. We need to ensure these individuals feel secure in their ability to afford every fill so they don't miss one dose, which can be dangerous for their health. Together, Cigna and Express Scripts are now able to give people who rely on insulin greater affordability and cost predictability so they can focus on what matters most: their well-being.” The Patient Assurance Program will be available to members in participating non-government funded pharmacy plans managed by Express Scripts, including Cigna and many other health plans, with out-of-pocket costs for insulin greater than $25. Out of pocket costs for insulin include deductibles, copays, or coinsurance. In most cases, people who use insulin will experience lower out-of-pocket costs without any increased cost to the plan. Cigna and Express Scripts clients will activate this new program for participating plans by moving covered insulin products to a lower copayment. Dr. Miller further noted that, “We are confident that our new program will remove cost as a barrier for people in participating plans who need insulin. Better care and better outcomes are rooted in greater choice, affordability, and access, and we can bring all of these to people with the greatest needs.” In 2018, the average out-of-pocket cost for insulin was $41.50 for a 30-day supply in 2018 for users of insulin plans managed by Cigna and Express Scripts. Through the Patient Assurance Program, individuals who are eligible for the program will save approximately 40 percent, “as well as gain peace of mind in knowing they will have access to improved affordability.” Patients with plans that involve coinsurance or a high deductible will benefit the most from this new program. According to research from Express Scripts, over 25% of the approximately 24 million Americans who are diagnosed with diabetes use insulin (either alone or along with other medications) to keep their blood glucose levels under control. A recent Yale study also found [FN2] that 1 in 4 people with diabetes who use insulin admitted to cutting back on the use of insulin because of cost concerns. OptumRx and UnitedHealthcare expand point-of-sale prescription drug discount program © 2020 Thomson Reuters. No claim to original U.S. Government Works. -2- OptumRx and UnitedHealthcare are expanding their consumer point-of-sale prescription drug discount programs to apply to all new employer-sponsored plans, which is intended to make medications more affordable and improve health outcomes. For new business proposals beginning January 2020, OptumRx and UnitedHealthcare will only support new employer clients that incorporate point-of-sale discounts to consumers as part of their plan design. This expansion enlarges the existing point-of-sale discount programs, announced a year ago and effective January 1, 2019, which will serve more than nine million consumers in 2019. For January and February 2019, the existing program has decreased prescription drug costs for consumers by an average of $130 per eligible prescription. UnitedHealthcare data analytics show that when consumers do not have a deductible or large out-of-pocket cost, medication adherence improves by between 4 and 16 percent depending on plan design. This greater adherence contributes to better health outcomes and reduces total health care costs for clients and the health system overall. According to John Prince, chief executive officer, OptumRx, “OptumRx is uniquely able to deploy the broadest range of tools to rein in high drug prices, and this expanded point-of-sale discount program demonstrates our commitment to delivering better prices for consumers.” Daniel J. Schumacher, president and chief operating officer of UnitedHealthcare, also commented on these programs. He stated that, “Patients are seeing concrete benefits from UnitedHealthcare's groundbreaking point-of-sale discount program, which is just one element in our commitment to help deliver better health, lower costs and a better experience. Together with employer partners and OptumRx, UnitedHealthcare has taken innovative action, bringing real value to consumers while mitigating the impact of persistent drug price inflation brought on by drug manufacturers affecting consumers' ability to afford medications and comply with their physician's [FN3] treatment plans.” Kaiser Family Foundation releases analysis comparing prescription drug spending and use in large private employer plans, Medicare Part D, and Medicaid The Kaiser Family Foundation recently released an analysis comparing prescription drug spending and use in large private employer plans, Medicare Part D, and Medicaid. The study was based primarily on claims data by payer, which does not account for rebates. Rebates tend to differ by payer, and are likely to be larger for Medicaid than Medicare Part D or private employers. The analysis found that spending by private health insurers, Medicare, and Medicaid accounts for most prescription drug spending in the U.S., but the types of individuals who receive prescription drug coverage from these three payers varies. Highlights from this analysis include: • Private health insurance, Medicare, and Medicaid accounted for 82% of total retail prescription drug spending in the U.S. in 2017, while patients paid 14% of the total as out-of-pocket payments; • For spending on specific drug products, the top five drug products with the highest total spending alone account for at least 10% of total prescription drug spending in large employer plans, Medicare Part D, and Medicaid; • While some of the same drug products appear among the top 10 drug products with the highest total spending in large employer plans, Medicare Part D, and Medicaid, there is also variation that reflects differing covered populations; • Out-of-pocket drug spending per user among people in large employer plans and Medicare Part D is highest for drugs to treat cancer, multiple sclerosis and rheumatoid arthritis; and • Antidiabetic agents, antivirals, and psychotherapeutics are among the top therapeutic classes by total spending in large employer plans, Medicare Part D, and Medicaid. After accounting for rebates, total U.S. retail prescription drug spending amounted to $333 billion in 2017. The majority of retail drug spending, 82%, was done by the three major sources of payment in the U.S. health system: private health insurance, Medicare, and Medicaid. Among all payers, private health insurance accounted for 42% of spending, Medicare accounted for 30%, and Medicaid accounted for 10%. Patient out-of-pocket costs accounted for 14% of total retail drug spending. Retail prescription drug spending accounted for 13% of total personal health care spending in private health insurance plans and 15% of personal health care spending in Medicare in 2017. Drug spending as a share of personal health care spending in Medicaid was lower, at 6%, likely because Medicaid also pays for more expensive services (such as long-term services and supports) that are not covered by private health insurance or Medicare. For these three major sources of payment, the top five drug products with the highest total spending alone account for at least 10% of total prescription drug spending by each payer, while the top 50 drug products account for approximately 40% of total prescription drug spending. These estimates, however, do not account for rebates. The top 50 drug products account for approximately 40% of total prescription drug spending for the three major sources of payment. The share of total prescriptions accounted for by the top 50 drug products is approximately 8% for both large employer plans and Medicaid, and 15% for Medicare Part D. In 2016, the drug product with the highest total spending in Medicare Part D and Medicaid was Harvoni, a curative treatment for hepatitis C. Harvoni was approved by the FDA in October 2014. Total spending on Harvoni was $4.4 billion in Medicare Part D and $2.2 © 2020 Thomson Reuters. No claim to original U.S. Government Works. -3- billion in Medicaid (not accounting for rebates payers may have received). The highest cost drug product for large employers in 2016 was Humira, a treatment for rheumatoid arthritis, with $4.9 billion in total spending (not accounting for rebates). There are two common products among the top 10 drug products with the highest total spending in large employer plans, Medicare Part D, and Medicaid: Harvoni, a treatment for hepatitis C, and Lantus Solostar, an insulin therapy for diabetes. In relation to total spending on prescription drugs by therapeutic class, antidiabetic agents and antivirals are among the top 3 classes for large employer plans, Medicare Part D, and Medicaid. Total spending on antidiabetic agents, the number one class for Medicare Part D, was $20.0 billion for Part D, $9.0 billion for large employers, and $5.7 billion for Medicaid (not accounting for rebates on drug products in these classes). Total spending on antivirals, the number one class for Medicaid, was $9.2 billion for Medicaid, $11.8 billion [FN4] for Medicare Part D, and $6.3 billion for large employer plans. Meijer announces that its pharmacies have filled 50 million free prescriptions since 2006 Retailer Meijer has announced that its Free Prescription Drug Program reached 50 million prescriptions filled since it was launched in 2006. The company established the program to help lower healthcare costs for families by focusing on antibiotic medications most often filled for children. Customers have saved over $650 million since the program began, and over $50 million in 2018 alone. Jason Beauch, Vice President of Meijer Pharmacy, stated that, “This program allows us to provide families necessary medications that best manage their health. We believe you can't put a price on wellness, so it's important for us to support local communities and do our part to help customers save on necessary medications and improve on their overall quality of life.” Any person interested in the program must bring in a doctor's prescription for the select medications that are currently part of the [FN5] program. Report examines Ohio Medicaid 2011 switch to managed care model for outpatient prescription drug benefits Researchers from the University of North Carolina Lineberger Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, and Boston University Questrom School of Business recently released a report examining the impact of Ohio Medicaid's switch in 2011 from a fee-for-service model to a managed care model to administer its outpatient prescription drug benefits. Pharmacy benefit managers are intermediaries in the drug supply chain that function as third-party administrators of pharmacy benefits. According to the researchers, an independent audit in 2018 found the change to a managed care program (using pharmacy benefit managers) saved the Ohio Medicaid program $145 million annually. These savings were mostly derived by the lower prescription claims prices the pharmacy benefit managers billed. Trevor Royce, MD, MS, MPH, the paper's corresponding author and an assistant professor of Radiation Oncology at UNC School of Medicine and UNC Lineberger, noted that these savings, however, came at a cost. Royce stated that, “Ohio policymakers should be applauded for their empirical approach in tackling the cost of prescription drugs. The Ohio audit found pharmacy benefit managers engage in opaque pricing practices that likely contribute to the rising costs of care and prescription drugs.” The authors also identified some potential issues of concern. Some Ohio pharmacists believed that pharmacy benefit managers used anti-competitive practices and manipulated drug pricing. Examples of this behavior included offering different drug pricing to affiliated pharmacies than independent pharmacies. Some pharmacy benefit managers also implemented “gag clauses” that prevented pharmacies from counseling patients on the most cost-effective medication options. Royce also noted that that some pharmacy benefit managers used “spread pricing,” where pharmacy benefit managers charged Ohio Medicaid a high price for a drug but paid pharmacies a lower price. The pricing difference could produce significant revenue for the pharmacy benefit managers. For example, an analysis in 2017 found that a 30-day supply of the generic form of imatinib mesylate, a drug to treat leukemia, cost $3,859, but Ohio Medicaid was charged $7,201. The independent review of pharmacy benefit manager practices commissioned by Ohio found an 8.8 percent difference between what the pharmacy benefit managers billed to Ohio Medicaid managed care plans and what it paid to the pharmacies between March of 2017 and March of 2018. Over 39 million prescription transactions produced a spread pricing difference of $223.7 million. Ohio officials have implemented several policy changes following the audit. The state's managed care plans terminated its contracts with pharmacy benefit managers and implemented a “pass through” pricing model in which the managed care plan pays the pharmacy benefit managers the exact amount paid to the pharmacy for a prescription drug plus a dispensing fee and an administrative fee. Ohio also attempted to ban the gag clauses used by pharmacy benefit managers, but the Ohio Senate failed to vote on the bill before the legislative session ended in 2018. This issue, however, was addressed at the federal level in October 2018 when laws banning gag clauses were signed into law. Royce stated that, “The Ohio Medicaid experience provides an important window into pharmacy benefit manager practices. Efforts to address drug pricing tend to focus on the pharmaceutical company or the drug manufacturer, while traditionally the pharmacy benefit managers may be overlooked. This is likely changing as a growing number of states have introduce bills pertaining to pharmacy benefit [FN6] manager practices, and more are surely to come.” © 2020 Thomson Reuters. No claim to original U.S. Government Works. -4- FTC report finds decrease in potentially anti-competitive pay for delay settlements in 2016 A recently released Federal Trade Commission staff report found that, despite an increase in the total number of final Hatch-Waxman patent settlements in FY 2016, significantly fewer settlements included the types of reverse payments that the agency deems to be “anticompetitive.” This report is the Bureau of Competition's third review of these agreements since the Supreme Court's decision in FTC v. Actavis, where the Court held that a branded drug manufacturer's reverse payment to a generic competitor to settle patent litigation can violate antitrust laws The recent report summarizes data on the 232 final patent settlements filed with the FTC and the Department of Justice during FY 2016 pursuant to requirements imposed by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The report's findings include the following information: • Only a single agreement contained a side deal or no-AG commitment, the types of reverse payments at issue in Actavis and, subsequently, in cases before appellate courts. This was the lowest number of such agreements since 2004; • In 29 of the 30 final settlements that contained compensation to the generic company and a restriction on selling a generic product for a period of time, the only explicit compensation was $7 million or less in litigation fees. In Actavis, the Court noted that avoided litigation expenses might constitute a justified payment; • The number of agreements with “possible compensation” to the generic company – provisions that might act as compensation, but would require inquiry into specific marketplace circumstances – increased to 14; • In 82 percent of final settlements, the generic company received rights not only to the patents at issue in the litigation, but also to licenses or covenants not to sue for all patents that the brand owns at any time after the settlement that might cover the generic product; and • Other features tracked by the report include provisions that accelerate the licensed entry date based on marketplace events and how parties settle when the generic company has launched its generic product at risk – before a final court decision on the patent merits – prior to settlement. According to FTC Chairman Joe Simons, “The data are clear: the Supreme Court's Actavis decision has significantly reduced the kinds of reverse payment agreements that are most likely to impede generic entry and harm consumers. These annual reports are an important tool to monitor how patent settlement agreements continue to evolve, and to identify provisions that might be anticompetitive.” [FN7] FTC staff will continue to publish similar annual reports as quickly as practicable. Research paper examines actual out of pocket consumer trends relating to generic drugs The National Bureau of Economic Research (NBER) released a report addressing the cost of generic drugs to consumers relative to pharmacies' revenue on these drugs. Researchers at NBER constructed two chained Laspeyres consumer price indexes (CPIs) using the 2007-2016 IBM MarketScan Commercial Claims and Encounters Research Database. The first (“direct out-of-pocket CPI”) measured consumers' direct out-of- pocket payments to the dispensing pharmacy. The second (“total CPI”) represented the total revenues received by the dispensing pharmacy, which equals the consumers' direct out-of-pocket payments plus the amount paid to the pharmacy by the insurer on behalf of the consumer. The researchers found that chained direct-out-of-pocket CPI for generic prescription drugs declined by approximately 50% between 2007 and 2016, while the total CPI fell by nearly 80% over the same time period. Researchers attributed the smaller decline in the direct out-of-pocket CPI compared to total CPI, in part, to consumers avoiding fixed copayment benefit plans and favoring pure coinsurance, or preferring a mixed package of coinsurance and copayments. They concluded that, “While consumers are experiencing more cost sharing that in fact shifts more of the drug cost burden on to them, [FN8] on balance in the US consumers have experienced substantial price declines for generic drugs.” American College of Physicians releases policy papers addressing prescription drug costs The American College of Physicians (ACP) recently released policy papers calling for changes that would address rising prescription drug costs. The papers, called “Policy Recommendations for Public Health Plans to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians” and “Policy Recommendations for Pharmacy Benefit Managers to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians,” were published in Annals of Internal Medicine. The two papers provide recommendations to improve transparency in industry and government, examine the role of the Pharmacy Benefit Manager (PBM), and address issues in public health plans that create barriers to care. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -5- According to Robert McLean, MD, MACP, president, ACP, “The U.S. pays more for prescription drugs than any other developed country—putting a great strain on our patients. As physicians, we have a responsibility to address issues that create obstacles to care for our patients, including skyrocketing prescription drug costs.” The American College of Physicians is the largest medical specialty organization in the United States with members in over 145 countries worldwide. ACP membership includes 159,000 internal medicine physicians (internists), related subspecialists, and medical students. The recent recommendations expand on ACP's 2016 policy paper, called “Stemming the Escalating Cost of Prescription Drugs.” The new recommendations focus on the need for increased transparency in how drugs are priced, lowering the out-of-pocket costs for patients, and enhancing the government's purchasing power. The papers also review the roles PBMs and public health plans play in the industry, as well as suggestions on how to address the increasing costs of prescription drugs. ACP's paper offers a series of recommendations that would potentially improve transparency surrounding PBMs and emphasizes the need for reliable and timely information on prescription drug pricing for physicians and patients. The American College of Physicians: • Supports improved transparency, standards, and regulation for PBMs, including a ban on “gag clauses” that prevent pharmacies from sharing pricing information with consumers; • Supports increased oversight and regulation when it comes to PBMs. Mergers and consolidations, which have increased over the years in the health care industry, could reduce competition, resulting in more costs being passed to patients; and • Believes health plans, PBMs, and pharmaceutical manufacturers should report the amount paid for prescription drugs, aggregate amount of rebates, and non-proprietary pricing information to the Department of Health and Human Services and make it publicly available. ACP's paper also addresses issues in public health plans, such as the Medicare and Medicaid programs, that can add costs to the health care system and increase expenses for patients. The American College of Physicians: • Supports modification to the Medicare Part D low-income subsidy (LIS) program cost-sharing and copayment structures to encourage the use of lower-cost generic or biosimilar drugs, such as eliminating cost-sharing for generic drugs for LIS enrollees; • Supports annual out-of-pocket spending caps for Medicare Part D beneficiaries who reach the catastrophic phase of coverage; • Supports the adoption of Medicare Part D negotiation models that would drive down the price of prescription drugs for beneficiaries; • Supports efforts to minimize the financial impact on the federal government of prescription drug misclassification in the Medicaid Drug Rebate Program (MDRP); and • Calls for further study of payment models in federal health care programs, including methods to align payment for prescription drugs administered in-office in a way that would reduce incentives to prescribe higher-priced drugs when lower-cost and similarly effective drugs are available. Dr. McLean noted that, “Internists have seen first-hand the how the increasing costs of prescription drugs have impacted patients.” McLeon further stated that, “Not all patients can afford the expensive out-of-pocket costs for vital drugs, and the high price tag can cause patients to not adhere to their medications, take incorrect doses to make their supply last longer, or forgo the medication they need altogether. It's more important than ever to continue advocating for policies that make prescription drugs more affordable and [FN9] accessible to patients, and ensure they are not boxed out of the care they need.” III. Legislation, regulation, and legal actions Senator Klobuchar and Grassley introduce bipartisan legislation to allow importation of drugs from Canada U.S. Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) recently introduced the Safe and Affordable Drugs from Canada Act. The Act is intended to allow individuals to safely import prescription drugs from Canada, creating major savings for consumers and bringing greater competition into the pharmaceutical market. Senator Klobuchar first introduced the Safe and Affordable Drugs from Canada Act with the late Senator John McCain (R-AZ) before his passing in 2018. According to Senator Klobuchar, “The skyrocketing prices of prescription drugs have made many lifesaving medications unaffordable for the people who need them, but our neighbors in Canada pay about half as much for their medications. Our legislation would allow for the safe importation of less expensive drugs from Canada, increasing competition, bringing down drug costs, and saving American families money. The bipartisan nature of the bill also continues with Senator Grassley taking up the mantle of the late Senator John McCain, who was the first to introduce this bill with me.” Senator Grassley also commented on the legislation, noting that, “For decades, safe and affordable prescription drugs have been for sale just across the border, but legally out of reach for American families. It's long past time for Congress to help the millions of © 2020 Thomson Reuters. No claim to original U.S. Government Works. -6- Americans who struggle to pay exorbitant prices for medication. Our bill would do exactly that. In the meantime, I'll keep up the fight against high prescription drug prices through increased competition and expanded access to more affordable generics.” Senators Klobuchar and Grassley have encouraged increased importation of prescription drugs from Canada in the past. In 2017, the two senators (and Senator McCain), urged HHS Secretary Tom Price to use statutory authority to fast-track the importation of prescription drugs from Canada. Grassley and McCain sent a similar letter to then-HHS Secretary Sylvia Matthews Burwell in 2015. Last congress, Grassley and Klobuchar pushed the FDA on certain drug importation policies and introduced the Creating and Restoring [FN10] Equal Access to Equivalent Samples (CREATES) Act in an attempt to reduce costs to patients. Vermont state agency releases report addressing state legislation to allow importation of drugs from Canada A recent report from the Vermont Agency of Human Services (AHS) addressed state legislation that would allow the wholesale importation of prescription drugs into Vermont. The law, called Act 133 of 2018, creates a wholesale prescription drug importation program, to the extent that funds are made available or appropriated. The potential program must comply with federal requirements regarding safety and cost savings, as assessed through an application to the Secretary of the U.S. Department of Health and Human Services (HHS). The National Academy for State Health Policy (NASHP) Center for State Rx Drug Pricing provided free technical assistance and design expertise through a grant from the Laura and John Arnold Foundation. AHS's report contains the preliminary design of a “Canadian Rx Drug Import Supply Program” and offers next steps for consideration of such a program. AHS determined that participating Vermont commercial insurers could see savings of between $1-5 million dollars by purchasing prescription drugs imported from Canada. These drugs would be made available through licensed Canadian drug suppliers and state- based, licensed wholesalers. The report also concluded that program licensure and program administration activities “are crucial for guaranteeing that imported prescription drugs pose no additional risk to health and safety.” These activities would likely be a substantial cost to the state, requiring upfront investment and appropriations. The AHS report included the following considerations for next steps: • Create detailed estimate of upfront and ongoing state expense to operate a program of prescription drug importation; such an estimate may require further contracted expertise; • Estimate the total potential savings of a program of prescription drug importation relative to markups, operating costs, and potential revenue; • Establish a clear mechanism for assuring that savings from prescription drug importation accrue to consumers; • Assess the interest of suppliers and wholesalers; • Legislative action to assign the appropriate state agencies for operating the wholesale drug importation program and corresponding appropriation of funds; • Legislative action enabling the OPR to create new license categories; and [FN11] • Submit a successful application to the Secretary of Health and Human Services. Pennsylvania state senator introduces bill to prohibit “spread pricing” and “gag clauses” relating to pharmacy benefit managers A bill sponsored by Pennsylvania state republican state senator Lisa Baker attempts to address agreements between pharmacy benefits managers and pharmacies. According to Senator Baker, “Our interest is in limiting as much as possible what Pennsylvanians have to pay for prescription drugs. We need to be more aggressive in policing this process so our citizens are not unknowingly paying more than they should for medicines they need.” The legislation is the result of a public hearing Baker conducted last year into concerns about the potentially anti-consumer aspects of the system of pharmacy benefit managers and drug prices. Senator Baker further noted that, “There are certain practices, such as spread pricing and gag clauses, which may result in bigger profits for companies and higher costs for customers. We find there are available remedies to correct the situation. We can draw on what neighboring states – Ohio and Maryland – have successfully done to save money for their consumers.” In addition to prohibiting “spread pricing” and “gag clauses,” Baker is also seeking to require the use of federal guidelines to set the price of prescription drugs filled through Medicaid and to establish a program rewarding pharmacies and pharmacy benefits managers if some compliance and cost saving measures are met. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -7- According to Baker, “This proposal contains the principles of transparency and fairness that we are trying to apply in every area of state law.” Senator Baker also added that, “This is not to diminish the importance of the savings realized since the pharmacy benefit manager system has been in place. Rather, our experience shows there are changes that can and should be made to provide a better deal for [FN12] prescription drug purchasers.” The Pennsylvania Senate Health and Human Services Committee convened a hearing regarding the role and impact of Pharmacy Benefit Managers (PBMs) in Pennsylvania, which led to Baker's recently proposed legislation. As third-party administrators of drug benefit programs for health plans, PBMs generally work to help contain costs. Those testifying pointed to a 30% savings on pharmacy benefits for managed plans as opposed to unmanaged plans. The terms of these agreements, however, are often unknown to consumers, and some practices have been questioned for their effectiveness. For example, pharmacists spoke about “spread pricing,” which allows PBMs to charge a plan sponsor more for a drug than it actually pays the pharmacy and pocket the difference. Many states have taken steps to more closely control these agreements. For example, Maryland now regulates how PBMs may negotiate with pharmacies. The state also prohibits “gag clauses” that prohibit a pharmacist from informing customers they may be able to save money by paying for medications out-of-pocket, rather than using their insurance coverage. Moreover, Ohio has forced its Medicaid Managed Care Organizations to renegotiate the terms of its contracts, saving an estimated $220 Million a year. Senator Baker noted that, “While PBMs play an important role in our health care system, concerns over transparency and fairness must be addressed.” In the near future, Baker stated that she plans to introduce legislation to: • Ban the use of “gag clauses” in PBM contracts with pharmacies. • Eliminate the practice of “spread pricing.” • Establish a value-based Pay for Performance program rewarding pharmacies and PBMs if certain metrics regarding drug adherence/ compliance and cost saving measures are met. • Allow PBMs to charge only a small, specified administrative fee per claim. • Require the use of the Centers for Medicare and Medicaid Services (CMS) National Average Drug Acquisition Cost (NADAC) to set the price of prescription drugs filled through Medicaid. • Provide for a reasonable professional dispensing fee to pharmacies to standardize reimbursements across the entire Medicaid population. This proposed legislation is not intended to eliminate all concerns related to PBMs. However, according to Senator Baker in a co- sponsorship memoranda, “it is a critical first step in addressing some of the problems identified. I hope you will consider joining me as a [FN13] cosponsor.” Florida governor announces plan for Canadian prescription drug importation program Florida Governor Ron DeSantis recently announced a plan for a prescription drug importation program for Florida. This proposed program will offer access to FDA-approved prescription drugs that have been imported from Canada, allowing the drugs to be sold to Floridians at a much lower cost. According to Governor DeSantis, “One of the biggest drivers of this country's out of control healthcare spending is the cost of prescription drugs. While our prices remain high, our neighbors in Canada are spending significantly less for the same drugs. These price disparities are indefensible and inexcusable and I am ready to act. I thank Speaker Oliva for prioritizing this issue and look forward to working with him to reduce the prices of these drugs for Floridians that depend on them.” In 2003, Congress passed the Medicare Modernization Act, which allows U.S. wholesalers and pharmacists to import prescription drugs from Canada, but only with the approval of the federal Department of Health and Human Services (HHS). HHS has refused to approve the practice, and DeSantis believes that 16 years since the passage of that law is long enough. Governor DeSantis states that he will work in conjunction with the Trump Administration and the Florida Legislature to create this [FN14] program “as quickly as possible while taking the necessary steps to ensure the appropriate regulatory protections are in place.” California lawmaker proposes bill prohibiting pay for delay agreements California Assemblymember Jim Wood (D-Santa Rosa), partnering with California's Attorney General Xavier Becerra, recently introduced AB 824, which is intended to stop pharmaceutical companies from “pocketing billions in profits” by using “pay-for-delay” practices. According to Wood, these practices result in an extension of patents on brand name drugs beyond what Congress intended when it passed the Hatch-Waxman Act of 1984. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -8- ”Pay-for-delay” refers to a system where a brand name drug manufacturer enters into a contract with a generic drug manufacturer that agrees to delay marketing a generic version of its drug in exchange for some benefit, which is most often a monetary payment. Some brand name drug manufacturers have used this approach to stifle competition, which, according to, Wood, violates the basic principles that govern the pharmaceutical patent system. Mr. Wood contends that, when a brand name drug patent expires, prices should decrease as generic manufacturers enter the market, decreasing costs to patients and health insurance companies. Assemblymember Wood also noted that, “It's unfortunate that the egregious acts of some drug companies taint the entire industry.” Wood further stated that, “The original purpose of the patent system established by the Hatch-Waxman Act was to allow drug companies to regain the funds they have invested in research, development and testing and to incentivize them to continue to innovate, not to reap billions beyond the patent expiration date. When drug companies use these quiet pay-for-delay agreements with generic drug manufacturers it hurts consumers twice – once by delaying the introduction of an equivalent generic drug that is almost always cheaper than the brand name and again by stifling additional competition when multiple generic companies begin producing even less expensive generic equivalents. This is just plain wrong.” Generic drugs currently cost significantly less than brand name drugs, with discounts off the brand price averaging 20 percent when the first generics are manufactured to up to as much as 90 percent when several companies are producing generics. Generic manufacturers can produce these drugs less expensively because they do not have to invest in research, development, and testing. According to the IMS Health Institute, generic drugs saved the U.S. health care system $1.67 trillion from 2007 to 2016. California Attorney General Xavier Becerra also commented on the proposed law, stating that, “Patients and consumers deserve to be free of unfair practices and price manipulation within the pharmaceutical industry. This legislation is a crucial step in combating predatory pricing practices, like “pay-for-delay” schemes, by drug companies and in defending access to affordable care.” Assemblymember Wood further note that, “When expensive brand name drug patents expire and the drug companies intentionally protect themselves from losing profits to generic manufacturers through these agreements, the only entities making a profit are the brand name drug manufacturer and the generic manufacturer – when all the generic manufacturer needs to do in order to make money is absolutely nothing. Who loses? The patients who deserve access to less expensive drugs and all of us who end up paying more for health care and, in turn, health care premiums. Affordability is a huge issue in health care, and this calculating practice makes it worse [FN15] and we need to stop it.” Connecticut lawmakers introduce bill intended to reduce out of pocket costs of prescription drugs Connecticut Rep. Sean Scanlon and Senator Matt Lesser, co-chairs of the state's Insurance and Real Estate Committee, recently announced new legislation to address the high cost of prescription drugs. The bill, House Bill 7174, adds to legislation authored and passed by Scanlon and Lembo in 2018 (Public Act 18-41), which created Connecticut's first prescription drug price transparency law. That Act, which was signed by the state governor on May 31, 2018, imposed disclosure and reporting requirements on pharmacy benefits managers, health carriers, pharmaceutical manufacturers, and the Office of Health Strategy and the Insurance Department concerning prescription drug rebates and the cost of prescription drugs. The recently proposed bill, HB 7174, is also intended to address the high cost of prescription drugs by: • Giving the Comptroller authority to establish a “Connecticut Prescription Drug Program” which allows individuals to enroll in the pharmacy benefit terms negotiated by the state for its state employee pool; • Authorizing the Comptroller to make the states pharmacy benefit terms available for qualified private employers; • Discouraging the anticompetitive practice known as “pay for delay” in which branded drug companies who pay generic drug companies to delay bringing their cheaper alternative to the market by requiring the particular drug to be sold at 50% of list price for the duration of the delay; • Protecting small pharmacies and consumers by preventing pharmacy benefit managers from imposing retroactive fees to recoup any claim payments already paid to the pharmacy at point of sale; • Providing a rebate to consumers at the point-of-sale; and • Creating a task force to study the feasibility of importing drugs from Canada. According to Rep. Scanlon, “Every single Connecticut resident is feeling the effects of rising prescription drug costs. The people of this state are fed up and want us to do something to lower their drug costs. By passing this legislation, we can give people the immediate relief at the pharmacy counter that they are demanding and deserve.” Senator Lesser also commented on the bill stating that, “We are committed to lowering the skyrocketing cost of prescription drugs. I've heard countless stories about the issues Connecticut residents have encountered due to the high cost of potentially lifesaving prescription drugs. I have also heard from constituents about high deductibles creating a financial roadblock, making it difficult to get necessary, costly procedures covered by their insurance. No one should be priced out of the healthcare market.” © 2020 Thomson Reuters. No claim to original U.S. Government Works. -9- Lesser further noted that, “We are in a position to change that for our state's residents and we are working towards that goal. We've introduced bills which are advancing in the legislative process, and we will continue working hard to make affordable prescription drugs and lower deductibles a reality for Connecticut residents.” Comptroller Kevin Lembo stated that, “Connecticut is going to call the shots on health care quality and cost now – and what we want is the best care for the best price. Connecticut's economic future – and the good of its workforce –demands access to affordable quality health care. How can our state possibly achieve economic growth if its workforce struggles to access basic needs like prescription drugs, or its small employers struggle to provide quality affordable basic health care to employees? For the sake of economic growth – and for the basic well-being of Connecticut residents – this must be a priority.” The AARP also weighed in on the Connecticut legislation and appears to support it. According to AARP Connecticut Director Nora Duncan, “Americans pay the highest prescription drug prices in the world, and the number one cause of bankruptcy in America is medical debt. People should not have to choose between the drugs they need and paying basic living expenses.” Duncan further stated that, “The bottom line on prescription drugs is that if the medication you need is not affordable, it's not accessible. AARP supports protecting seniors and all taxpayers from drug company price gouging, helping people get the drugs they need at a [FN16] price they can afford, closing loopholes that block generics from entering the market, and transparency in drug pricing.” Colorado legislature introduces Drug Cost Reduction Act The Colorado state legislature is currently considering the “Colorado Prescription Drug Cost Reduction Act of 2019.” According to the legislation's summary, the bill is “Concerning measures to reduce prescription drug costs, and, in connection therewith, creating the “Colorado Prescription Drug Cost Reduction Act of 2019” to require health insurers, prescription drug manufacturers, pharmacy benefit management firms, and nonprofit organizations to report specified information about the costs of prescription drugs to the commissioner of insurance; to direct the commissioner to analyze the information and submit a report regarding the effects of prescription drug costs on health insurance premiums; to preclude pharmacy benefit management firms from retroactively reducing payments to pharmacies; and to require carriers to reduce consumer cost sharing for prescription drugs to reflect rebates the carrier or pharmacy benefit management firm received.” The bill is sponsored by representatives Dominique Jackson and Sonya Jaquez Lewis, as well as state senators Joann Ginal and Kerry Donovan. Section 1 of the bill enacts the “Colorado Prescription Drug Cost Reduction Act of 2019,” which requires: • Health insurers (starting in 2020), to submit to the commissioner of insurance (commissioner) information regarding prescription drugs covered under their health insurance plans that the plan paid for in the preceding calendar year, including information about rebates received from prescription drug manufacturers, a certification regarding how rebates were accounted for in insurance premiums, and a list of all pharmacy benefit management firms (PBMs) with whom they contract; • Prescription drug manufacturers to notify the commissioner, state purchasers, health insurers, and PBMs when the manufacturer, on or after January 1, 2020, increases the price of certain prescription drugs by more than specified amounts or introduces a new specialty drug in the commercial market; • Prescription drug manufacturers, within 15 days after the end of each calendar quarter that starts on or after January 1, 2020, to provide specified information to the commissioner regarding the drugs about which the manufacturer notified purchasers; • Health insurers or, if applicable, PBMs to annually report specified information to the commissioner regarding rebates and administrative fees received from manufacturers for prescription drugs for which they received the required notice from a manufacturer; and • Certain nonprofit organizations to compile and submit to the commissioner an annual report indicating the amount of each payment, donation, subsidy, or thing of value received by the nonprofit organization or its executive director, chief operating officer, board of directors, or any member of the board of directors from a prescription drug manufacturer, PBM, or health insurer and the percentage of the nonprofit organization's total gross income that is attributable to those payments, donations, subsidies, or things of value. The commissioner is required to post the information received from health insurers, prescription drug manufacturers, PBMs, and nonprofit organizations on the division of insurance's website, excluding any information that is proprietary. Furthermore, the commissioner, or a disinterested third-party contractor, must analyze the data reported by health insurers, prescription drug manufacturers, PBMs, and nonprofit organizations and other relevant information to determine the effect of prescription drug costs on health insurance premiums. The commissioner must publish a report each year, submit the report to the governor and specified legislative committees, and present the report during annual “State Measurement for Accountable, Responsive, and Transparent (SMART) Government Act” hearings. The commissioner is authorized to adopt rules as necessary to implement the requirements of the bill. Section 2 prohibits PBMs from retroactively reducing payment on a clean claim submitted by a pharmacy unless the PBM determines, through an audit conducted in accordance with state law, that the claim was not a clean claim. Health insurers that contract with PBMs © 2020 Thomson Reuters. No claim to original U.S. Government Works. -10- must ensure that the PBMs are complying with this prohibition and the reporting requirements and are subject to penalties for failure to do so. Section 3 requires a carrier to reduce the cost sharing a covered person is required to pay for prescription drugs by an amount equal to the greater of 51% of the average aggregate rebates received by the carrier for all prescription drugs, including price protection rebates, or an amount that ensures cost sharing will not exceed 125% of the carrier's cost for the prescription drug. Under sections 5 and 6, a prescription drug manufacturer that fails to notify purchasers or fails to report required data to the commissioner is subject to discipline by the state board of pharmacy, including a penalty of up to $10,000 per day for each day the manufacturer fails to comply with the notice or reporting requirements. The commissioner must report manufacturer violations to the state board of pharmacy. Moreover, health insurers that fail to report the required data are subject to a fine of up to $10,000 per day. Sections 7 and 8 of the bill make conforming amendments necessary to harmonize the bill with the title 12 recodification bill, House Bill [FN17] 19-1172. FTC sues Surescripts alleging illegal restraints of trade that could increase costs for consumers The Federal Trade Commission recently sued the health information company Surescripts, alleging that the company employed illegal vertical and horizontal restraints in order to maintain its monopolies over two electronic prescribing, or “e-prescribing,” markets: routing and eligibility. In the complaint filed on April 17, 2019 against Surescripts, the FTC seeks to undo and prevent Surescripts's allegedly unfair methods of competition, restore competition, and provide monetary redress to consumers. According to Bureau of Competition Director Bruce Hoffman “For the past decade, Surescripts has used a series of anticompetitive contracts throughout the e-prescribing industry to eliminate competition and keep out competitors. Surescripts's illegal contracts denied customers and, ultimately, patients, the benefits of competition – including lower prices, increased output, thriving innovation, higher quality, and more customer choice. Through this litigation, we hope to eliminate the anticompetitive conduct, open the relevant markets to competition, and redress the harm that Surescripts's conduct has caused.” E-prescribing provides a safer, more accurate, and lower-cost means to communicate and process patient prescriptions than traditional paper prescribing. According to the complaint, Surescripts monopolized two separate markets for e-prescription services: • The market for routing e-prescriptions, which uses technology that enables health care providers to send electronic prescriptions directly to pharmacies; and • The market for determining eligibility, a separate service that enables health care providers to electronically determine patients' eligibility for prescription coverage through access to insurance coverage and benefits information, usually through a pharmacy benefit manager. The FTC alleges that Surescripts intentionally set out to keep e-prescription routing and eligibility customers on both sides of each market from using additional platforms (also known as multihoming) using anticompetitive exclusivity agreements, threats, and other exclusionary tactics. Among other actions, the FTC alleges that Surescripts took steps to increase the costs of routing and eligibility multihoming through loyalty and exclusivity contracts. According to the FTC's complaint, Surescripts successfully used these tactics to stop multiple attempts by other companies to enhance competition in the routing and eligibility markets. According to the FTC's complaint, Surescripts's anticompetitive tactics thwarted competitors from gaining share in the routing and eligibility markets, enabling the company to maintain at least a 95 percent share in each market over many years. The complaint alleges that Surescripts succeeded in maintaining its monopolies in routing and eligibility, despite the large growth of routing and eligibility transactions from nearly 70 million routing transactions in 2008 to over 1.7 billion in 2017. The Commission vote to file the complaint was 5-0, and the complaint was filed under seal in the U.S. District Court for the District of Columbia on April 17, 2019. A redacted version of the complaint was also filed. The complaint alleges that Surescripts's anticompetitive acts violate Section 2 of the Sherman Act, and thus constitute an unfair method of competition, in violation of Section 5(a) of the FTC Act, 15 U.S.C. § 45(a). The Commission files a complaint when it has “reason to believe” that the law has been or is being violated and it appears to the Commission that a proceeding is in the public interest. The case will be decided by the federal district court. According to its website, “The Federal Trade Commission works to promote competition, and protect and educate consumers.” The FTC has recently been active in opposing anticompetitive behavior of drug companies. In early 2019, it reached a global settlement with the pharmaceutical manufacturer Teva Pharmaceuticals Industries Ltd., barring the company from engaging in reverse-payment patent settlement agreements that block consumers' access to lower-priced generic drugs. In March 2019, the Commission barred Impax Laboratories LLC from entering into reverse-payment patent settlements after concluding that Impax used this tactic to block consumers' access to a generic version of the extended-release opioid pain reliever Opana © 2020 Thomson Reuters. No claim to original U.S. Government Works. -11- ER. Also, in 2018, a federal court ordered AbbVie Inc., to pay $448 million to consumers who allegedly overpaid for testosterone [FN18] replacement drug Androgel because of AbbVie's illegal tactics to maintain its monopoly over the drug. Several states file suit against generic drug makers alleging antitrust violations and artificially high prices Ohio Attorney General Dave Yost recently joined 44 states in announcing an antitrust lawsuit against 20 of the nation's largest generic drug manufacturers alleging a widespread conspiracy to artificially inflate and manipulate prices, reduce competition, and unreasonably restrain trade for more than 100 different generic drugs. The drugs at issue account for billions of dollars of sales in the United States, and the alleged schemes increased prices affecting the health insurance market, taxpayer-funded healthcare programs such as Medicare and Medicaid, and individuals who must pay artificially-inflated prices for their prescription drugs. According to Yost, “Ohioans who need medicine might think generic drugs would be their cheapest option – but some manufacturers have rigged the systems to avoid competition. That's not how a free market works, and the conspiracy to avoid competition makes prices higher – and it's against the law. This lawsuit is the prescription for lower medicine prices in a free market.” The lawsuit, filed in U.S. District Court for the District of Connecticut, also names 15 individual senior executive defendants allegedly involved in the conspiracy who were responsible for sales, marketing, pricing, and operations. The complaint alleges that Teva, Sandoz, Mylan, Pfizer and 16 other generic drug manufacturers engaged in a broad, coordinated and systematic campaign to conspire with each other to fix prices, allocate markets and rig bids for more than 100 different generic drugs. The involved drugs are wide ranging, including tablets, capsules, suspensions, creams, gels, ointments, and classes, including statins, ace inhibitors, beta blockers, antibiotics, anti-depressants, contraceptives, non-steroidal anti-inflammatory drugs, and treat a range of diseases and conditions from basic infections to diabetes, cancer, epilepsy, multiple sclerosis, HIV, ADHD, and more. In some cases, the alleged coordinated price increases were over 1,000%. The complaint alleges an interconnected web of industry executives where these competitors met with each other during industry dinners, “girls nights out,” lunches, cocktail parties, golf outings, and communicated via frequent telephone calls, emails, and text messages that facilitated their allegedly illegal agreements. Throughout the complaint, the plaintiffs allege that defendants used terms such as “fair share,” “playing nice in the sandbox,” and “responsible competitor” to describe how they allegedly unlawfully discouraged competition, raised prices, and enforced an ingrained culture of collusion. The lawsuit seeks damages, civil penalties, and actions by the court to restore competition to the generic drug market. The complaint is the second to be filed as part of an ongoing investigation that the Connecticut Office of the Attorney General has referred to as possibly the largest cartel case in the history of the United States. The first complaint, still pending in U.S. District Court in the Eastern District of Pennsylvania, was filed in 2016 and now includes 18 corporate defendants, two individual defendants, and 15 generic drugs. The corporate defendants in the recently filed suit include Teva Pharmaceuticals USA, Inc., Sandoz, Inc., Mylan Pharmaceuticals Inc., Actavis Holdco US, Inc., Actavis Pharma, Inc., Amneal Pharmaceuticals, Inc., Apotex Corp., Aurobindo Pharma U.S.A., Inc., Breckenridge Pharmaceutical, Inc., Dr. Reddy's Laboratories, Inc., Glenmark Pharmaceuticals Inc. USA, Greenstone LLC, Lannett Company, Inc., Lupin Pharmaceuticals, Inc., Par Pharmaceutical Companies, Inc., Pfizer, Inc., Taro Pharmaceuticals USA, Inc., Upsher-Smith Laboratories, LLC, Wockhardt USA, LLC, and Zydus Pharmaceuticals (USA), Inc. The individual defendants include Ara Aprahamian, Vice President of Sales and Marketing at Taro Pharmaceuticals U.S.A, Inc., David Berthold, Vice President of Sales at Lupin Pharmaceuticals, Inc., James Brown, Vice President of Sales at Glenmark Pharmaceuticals, Inc., Maureen Cavanaugh, former Senior Vice President and Chief Commercial Officer, North America, for Teva, Marc Falkin, former Vice President, Marketing, Pricing and Contracts at Actavis, James Grauso, former Senior Vice President, Commercial Operations for Aurobindo from December 2011 through January 2014 (Since February 2014, Grauso has been employed as the Executive Vice President, N.A. Commercial Operations at Glenmark), Kevin Green, former Director of National Accounts at Teva from January 2006 through October 2013 (Since November 2013, Green has worked at Zydus Pharmaceuticals (USA) Inc. as the Vice President of Sales), Armando Kellum, former Vice President, Contracting and Business Analytics at Sandoz, Jill Nailor, Senior Director of Sales and National Accounts at Greenstone, James Nesta, Vice President of Sales at Mylan, Kon Ostaficiuk, the President of Camber Pharmaceuticals, Inc., Nisha Patel, former Director of Strategic Customer Marketing and later, Director of National Accounts at Teva, David Rekenthaler, former Vice President, Sales US Generics at Teva, Richard Rogerson, former Executive Director of Pricing and [FN19] Business Analytics at Actavis, and Tracy Sullivan DiValerio, Director of National Accounts at Lannett. The attorney general of Florida (which is also a plaintiff in the lawsuit), Ashley Moody, also commented on the case, stating that, “Inflating and manipulating the pricing of essential drugs prescribed to those with chronic conditions is shameful. Routine health care can already be a burdensome cost for individuals, not to mention those suffering with life-altering and critical illnesses, and patients should not have to further worry about rising prescription drug costs of medicine they may desperately need. I am proud of my office for being one of the lead states in this ongoing investigation, and I hope this new complaint will help restore faith that drug pricing and our [FN20] marketplace are both legal and fair.” © 2020 Thomson Reuters. No claim to original U.S. Government Works. -12- Maine governor signs into law comprehensive prescription drug reform legislation increasing transparency and allowing drug importation Maine Governor Janet Mills recently signed into law a comprehensive prescription drug reform package containing provisions that will allow the wholesale importation of prescription medicine, create a prescription drug affordability board, increase drug price transparency, and better regulate pharmacy benefit managers. The package includes: • LD 1272, “An Act To Increase Access to Low-cost Prescription Drugs,” would set up a wholesale prescription drug importation program with approval from the U.S. Department of Health and Human Services. The Trump administration has indicated its support for similar measures in other states, including Florida and Colorado. This bill is modeled after a Vermont law that passed last year. Maine's proposal also includes language directing the Department of Health and Human Services to consider whether the program may be developed in conjunction with other states. • LD 1499, “An Act To Establish the Maine Prescription Drug Affordability Board,” would create a Prescription Drug Affordability Board. This board would determine prescription drug spending targets for public entities based on a 10-year rolling average, accounting for inflation with spending reductions, and would provide methods for achieving lower prescription costs through measures such as bulk purchasing, leveraging multi-state purchasing, or negotiating specific rebate amounts. • LD 1162, “An Act To Further Expand Drug Price Transparency,” would gather information related to the pricing of drugs all along the supply chain from manufacturers to wholesalers, pharmacy benefit managers and insurance companies. This bill builds upon previous legislation introduced by Senator Vitelli, which became law last year. Other bills in this package rely on this data to understand how the costs of development, advertising, and profits affect pricing for the consumer. • LD 1504, “An Act To Protect Consumers from Unfair Practices Related to Pharmacy Benefits Management,” prohibits pharmacy benefit managers from retaining rebates paid by manufacturers and requires those rebates to be passed along to the consumer or the health plan. Pharmacy benefit managers (PBMs), often referred to as “middlemen,” have come under national scrutiny for driving up costs and pocketing savings despite claims that PBMs work on behalf of consumers negotiate lower drug prices. Rebates can drive up drug prices because they incentivize high wholesale prices and hide the cost of drugs from the consumer. Governor Mills commented on the legislation, noting that, “The outrageous prices of prescription drugs are hurting Mainers, especially older Mainers on a fixed and limited income. No one should have to choose between food or medicine. With this package of legislation, Maine is taking a major step forward in tackling this issue and standing up for Maine people. I applaud Senate President Jackson, Senator Vitelli, Senator Sanborn, Senator Foley, Representative Prescott, the AARP and others who championed these much-needed bills.” According to a press release from the Governor's office, one in four Americans struggle to pay for their prescription medication, and one in ten Americans fail to take their medicine as prescribed due to cost. According to the National Academy for State Health Policy, approximately 200 bills have been filed in 42 state legislatures to address the cost of prescription drugs. According to state senate President Troy Jackson, “For too long, Mainers have seen their prescription drug costs skyrocket because politicians were too afraid to take on Big Pharma. Today, that changes. With this prescription drug reform package, we are delivering long-overdue relief for Mainers. I'm proud that we were able to pass into law a suite of bills that go beyond simple fixes; it brings real reform and accountability to a dysfunctional system that has long prioritized outlandish profits over people's lives.” State senator Eloise Vitelli also commented on the legislation, stating that, “The more transparency there is in prescription drug pricing, the more we'll be able take targeted action to help reduce the costs of these life-supporting medications. This law builds on existing disclosure requirements in Maine law and seeks out data from companies whose drug prices have increased significantly. The report issued last year by the Maine Health Data Organization is a powerful tool that lets Mainers and officials know what pharmaceutical [FN21] companies are charging patients. I'm glad that we're are now able to expand on that success, to help even more Maine people.” Several drug makers settle pay for delay claims with state of California for $70 million and injunctive relief California Attorney General Xavier Becerra recently announced four settlement agreements against several pharmaceutical companies for entering into allegedly collusive “pay-for-delay agreements” that delay more affordable prescription drugs from entering the marketplace. Pay-for-delay agreements occur when name brand and generic drug companies avoid litigation by agreeing that the brand name company will compensate the generic drug maker to prevent it from entering the market with its generic version of the brand name drug for a specified period of time. The settlements will result in the involved pharmaceutical companies paying nearly $70 million to the state of California. These settlements include the largest pay-for-delay settlement received by any state. They are also the first to secure injunctive relief for a state against future pay-for-delay agreements. The first settlement with Teva addresses anticompetitive pay-for-delay agreements that delayed a generic narcolepsy drug, Provigil, from entering the market for nearly six years. The three other settlements with Teva, Endo Pharmaceuticals, and Teikoku address © 2020 Thomson Reuters. No claim to original U.S. Government Works. -13- similar practices that prevented a generic version of the drug Lidoderm (used to treat shingles) from entering the market for almost two years. Becerra's office claims that pay-for-delay agreements cause consumers to pay as much as 90% more for drugs protected from competition. According to Attorney General Becerra, “These dark, illegal, collusive agreements that drug companies devise not only choke off price competition but burden our families and patients—they force every Californian to shoulder higher prices for life-saving medication. It's nothing less than playing with people's lives.” Becerra further noted that, “Californians shouldn't have to pay an arm and leg to afford their prescriptions. That's why I am vigorously advocating for stronger laws, like AB 824 by Assemblymember Jim Wood, to deter this conduct and build on enforcement actions like the ones I'm announcing today. Together, these actions will help us push back on greedy drug companies and fight for California families.” The four recently announced settlements include: • Provigil Settlement: Attorney General Becerra argued that Teva delayed entry of generic competition through four pay-for-delay agreements that illegally maintained its monopoly over Provigil sales between 2006 and 2012. This resulted in artificially high costs of Provigil for consumers. As a result, Attorney General Becerra secured $69 million for California and a 10-year injunction prohibiting Teva from entering into pay-for-delay agreements in the state. • As part of the $69 million settlement, a $25,250,000 consumer fund will be created for California residents who purchased Provigil, Nuvigil or Modafinil during this timeframe. Consumers can learn more details at the Attorney General's website. • The money from this settlement will be used to strengthen Attorney General Becerra's investigative and enforcement work in cases like these to protect affordable, quality healthcare for all Californians. • Lidoderm Settlements: Attorney General Becerra argued that Teva, Endo Pharmaceuticals, and Teikoku entered into pay-for-delay agreements regarding Lidoderm, a medical patch to relieve shingles pain. • In June 2019, Attorney General Becerra settled with Endo Pharmaceuticals, securing an eight-year injunction against further pay-for delay agreements and payment of $760,000. Attorney General Becerra also secured a 20-year injunction against Teikoku, a partner in the production of the drug Lidoderm with Endo. Californians who believe they may be victims of Teva's alleged misconduct may file a form available at www.oag.ca.gov/report. These individuals will be notified when the parties establish a claims process for the settlement. Attorney General Becerra is also currently sponsoring AB 824 with Assemblymember Jim Wood. This law would deter pay-for-delay [FN22] agreements and increase enforcement against those who engage in such conduct. New York Congressman introduces bill aimed at addressing prescription drug costs New York Congressman Joe Morelle recently introduced legislation intended to address and reverse the increasing costs of prescription drugs. The Lower Drug Costs Now Act (H.R. 3), which Rep. Morelle co-sponsors, attempts to “help ensure life-saving medication is accessible and affordable for all people, especially seniors and those with low or fixed incomes.” According to Representative Morelle, “The exorbitant cost of prescription drugs in America shows how profoundly out of touch our healthcare system truly is. These inflated costs place a significant and dangerous burden on families, especially older Americans who rely on Medicare. I'm proud to co-sponsor this critical legislation and take action to rein in costs and make healthcare more affordable for everyday Americans.” As currently written, the proposed legislation: • Ends the ban on Medicare negotiating directly with the drug companies and creates powerful new tools to force drug companies to the table to agree to real price reductions, while ensuring seniors never lose access to the prescriptions they need; • Makes the lower drug prices negotiated by Medicare available to all Americans, including those with private insurance, not just Medicare beneficiaries; • Stops drug companies that are ripping off Americans while charging other countries less for the same drugs by establishing a maximum price for any negotiated drug with an international price index; • Creates a new, $2,000 out-of-pocket limit on prescription drug costs for Medicare beneficiaries, and reverses years of unfair price hikes above inflation across thousands of drugs in Medicare; and • Reinvests in innovation and the search for new cures and treatments, putting the savings from lowering inflated drug prices towards research at National Institutes of Health. Ann Marie Cook, President/CEO of Lifespan of Greater Rochester, commented on the proposed law, stating that, “Every day older adults contact us seeking help to pay for prescription drugs. Every day, we see older adults making the heartbreaking decision to eat or fill their medications. Every day we talk to people who cut their pills in half to make them go further.” © 2020 Thomson Reuters. No claim to original U.S. Government Works. -14- Ms. Cook also noted that, “It is impossible for people on fixed incomes to absorb the ever-increasing cost of prescription drugs. I sincerely applaud Congressman Morelle for sponsoring The Lower Drug Costs Now Act (H.R. 3) which will help older adults gain access to affordable medications so they can live without fear of financial ruin due to rising health care costs.” Representative Morelle contends that prescription drug companies are charging Americans prices that are three to ten times higher than what they charge for the same drugs in other countries (even though these companies still make a profit at lower costs). In June, Representative Morelle highlighted a report from the House Committee on Oversight and Reform which found that the cost of diabetes medication in the 25th Congressional District is up to 21 times higher than the cost of the same drugs in Australia, averaging over $450 per month. Representative Morelle also notes that older adults are particularly affected by high prescription drug costs. For example, Medicare Part D enrollees take an average of four to five prescriptions per month and over two-thirds have two or more concurrent chronic illnesses. Morelle also notes that, “The Lower Drug Costs Now Act takes action to end this inequity and make healthcare more affordable.” Representative Morelle further commented that, “No American should have to ration or stop taking lifesaving medication because they cannot afford its rising and grossly inflated cost. That's why Congress is taking much-needed action to address this and ensure we prioritize people over profits. I will continue to support and advance policies that help make healthcare more affordable for individuals [FN23] and families in our community and across the nation.” California governor signs two bills intended to lower cost of prescription drugs in the state California Governor Gavin Newsom recently signed into law two bills intended to lower the cost of prescription drugs. These bills aim to prevent pharmaceutical companies from keeping cheaper generic medicine off the market and expand access to PrEP and PEP HIV medication. AB 824 makes California the first state to legislatively address pay-for-delay agreements, which, according to the governor's office, “hurt consumers and increase drug company profits by blocking the development of generic drug competition.” According to a Federal Trade Commission study, these pay-for-delay agreements cost consumers and taxpayers approximately $3.5 billion in higher drug costs every year. The bill prohibits these agreements between brand name and generic drug manufacturers by making them presumptively anticompetitive. Governor Newsom commented on this law, stating that, “California will use our market power and our moral power to take on big drug companies and prevent them from keeping affordable generic drugs out of the hands of people who need them. Competition in the pharmaceutical industry helps lower prices for Californians who rely on life-saving treatments.” SB 159 authorizes pharmacists to furnish pre- and post-exposure prophylaxis (PrEP and PEP) without a physician's prescription. The bill also prevents insurance companies from requiring prior authorizations for patients to obtain PrEP coverage. The state budget includes one-time $40 million General Fund for infectious diseases prevention and control and ongoing $2 million General Fund specifically to address sexually transmitted diseases, as well as an additional ongoing $5 million General Fund for HIV prevention and control. Governor Newsom noted that, “Recent breakthroughs in the prevention and treatment of HIV can save lives. All Californians deserve access to PrEP and PEP, two treatments that have transformed our fight against HIV and AIDS. I applaud the Legislature for taking [FN24] action to expand access to these treatments and getting us closer to ending HIV and AIDS for good.” Biosimilars bill introduced in Congress New York Congressman Anthony Brindisi, along with Reps. Scott Peters (CA-52) and Pete King (NY-02), recently introduced the bipartisan Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act. The legislation, currently supported by many Democrats and Republicans, is intended to eliminate a patient's copay for a biosimilar drug if they normally would pay full cost of a biologic drug under Medicare Part B. The bill is intended to reduce medical costs by increasing access to lower-cost biosimilar drugs and give Americans more treatment options. Similar to generic drugs, biosimilars offer a lower-cost opportunity to treat expensive diseases and illnesses. They are some of the “most innovative physician-administered drugs and are successfully treating complex diseases like cancer, rheumatoid arthritis, Crohn's disease, and ulcerative colitis.” The U.S. Food and Drug Administration (FDA) deemed approved biosimilars to be as safe and effective as their biologic counterparts, but many are still not available to Americans. According to Rep. Brindisi “Every day I hear from Upstate New Yorkers who cannot afford the medication they need, and it is way past time for Democrats and Republicans to take action. Our bill will eliminate out of pocket costs for millions of seniors. I am proud to work with Rep. Peters and Rep. King on this legislation to help increase competition and bring drug costs down for seniors and working families.” In Europe, over 40 biosimilar products are available. The Congressional Research Service reports that, while less than two percent of Americans use biologics, they account for 40 percent of total spending on prescription drugs. The RAND Corporation estimates biosimilars could save the United States as much as $54 billion over the next decade. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -15- Rep. Peters also commented on the proposed legislation, stating that, “San Diego is home to a world-class life science sector that is uncovering new ways to improve and save lives. The government can and should drive down drug costs and one way we can do that is by increasing competition. If we eliminate copays on biosimilars, it will increase their widespread use and provide a market incentive to drive down overall drug costs. I am committed to lowering health care costs and expanding treatment options for all Americans, and the bipartisan ACCESS Act does just that.” According to Rep. King, “This legislation represents an important step toward containing drug prices for some of the most expensive therapies,” King said. “By increasing patient access and encouraging development of more biosimilars this legislation would save [FN25] Medicare beneficiaries and taxpayers billions of dollars.” U.S. House unanimously passes legislation intended to increase transparency of PBMs The U.S. House of Representatives recently unanimously voted to pass H.R. 2115, Public Disclosure of Drug Discounts Act, introduced by Representatives Abigail Spanberger (D-VA-07), Jodey Arrington (R-TX-19), and Brendan Boyle (D-PA-02). The bill would require Pharmacy Benefit Managers (PBMs) to report their aggregate rebates, discounts, and other price concessions for prescription drugs to a public website, allowing consumers, employers, and other payers to understand and compare the discounts PBMs receive. In 2016, PBMs, which act as the middlemen between pharmaceutical manufacturers, insurers, and patients, earned an estimated $22.6 billion in gross profits as consumer drug costs increased. Furthermore, the three largest PBMs in the United States—Express Scripts, CVS Caremark, and Optum Rx—control nearly three-quarters of the U.S. prescription drug supply chain. Currently, patients and pharmacists are unable to view the rebates and discounts received by powerful PBMs. Because of this fact, consumers are unable to learn more about how PBMs could be triggering rising drug prices and increasing their out-of-pocket costs. The Spanberger-led Public Disclosure of Drug Discounts Act is intended to hold PBMs accountable by requiring PBMs to report their aggregate rebates, discounts, and other price concessions for prescription drugs to a public website. This heightened level of market transparency is intended to help patients, pharmacists, employees, and business owners better understand and compare the discounts PBMs receive from drug manufacturers. Representative Spanberger spoke on the floor of the U.S. House to call on her colleagues to support and pass her bipartisan bill. During her speech, she highlighted the consistent concerns of the Central Virginians she represents about the rising cost of prescription drugs. She also referenced her August 2019 prescription drug roundtable in Henrico County, where she heard concerns from patients and pharmacists about the influence of PBMs on the prescription drug marketplace. Under the typical PBM business model, the rebates drug manufacturers pay to PBMs are based on the PBM's ability to drive market share. Even if drug list prices increase, PBMs may recoup greater rebate dollars. Representative Spanberger contends that policymakers need transparency to assess the impact of PBMs' business model on health care costs and to better understand the amount of rebates, as well as determine how much value they add for patients. According to Spanberger, H.R. 2115 would increase transparency by requiring the Secretary of the Department of Health and Human Services (HHS) to publicly post aggregate rebate data and generic dispensing rates, which is data PBMs already report by law. Information on rebates by class of drug would be made publicly available under the legislation, to the extent the disclosure does not display confidential information regarding rebates achieved for an individual drug. In Medicare, PBMs negotiate rebates (and other “discounts”) with drug manufacturers for Medicare Part D plans. The compensation PBMs receive after the prescription drug has been filled at the pharmacy is called Direct and Indirect Remuneration (DIR), which accounted for $23.6 billion or 17 percent of gross Medicare Part D costs in 2015. DIR includes drug manufacturer rebates, as well as certain compensation arrangements with pharmacies. This bill would make some information related to DIR publicly available and more transparent. Representative Spanberger noted that, “But for many Americans, PBMs remain a mysterious player within the prescription drug marketplace. Operating in the murky world of drug negotiation, there are few windows into the value of the rebates and discounts PBMs receive from drug companies. Effectively, they're a black box in the long supply chain from the pharmaceutical company to the patient.” She also stated that, “During our roundtable in Henrico, one local pharmacist described how PBMs continue to enjoy record profits thanks to the pharmaceutical industry—while patients and pharmacists get stuck with unsustainable costs…. Right now, the three largest PBMs control three-quarters of the U.S. prescription drug market. There seems to be little transparency, and where there's zero transparency, there is rarely room for accountability or oversight. If we don't cast sunlight into this black box, patients will continue to be left in the dark about the effect of PBMs on the prices of specific drugs.” Spanberger further noted that, “The Public Disclosure of Drug Discounts Act would be a step towards bringing greater transparency to this broken system. The principle behind my bill is simple—let's take the information already provided to the federal government, and let's make it public. PBMs are already required to declare rebate data, discounts, and generic dispensing rates to HHS. But under my bill, this information would be posted publicly for the general public to see. But beyond the principle of my bill, the goal is even simpler— [FN26] lowering drug costs for our neighbors.” © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service © 2020 Thomson Reuters. No claim to original U.S. Government Works. -16- [FN1] . “PhRMA Decries Damaging Foreign Practices in Special 301 Filing,” February 8, 2019, available at: https://www.phrma.org/press- release/phrma-decries-damaging-foreign-practices-in-special-301-filing. [FN2] . “Cigna and Express Scripts Introduce Patient Assurance Program to Cap Out Of Pocket Costs at $25 per 30-Day Insulin Prescription,” April 3, 2019, available at: https://www.cigna.com/newsroom/news-releases/2019/cigna-and-express-scripts-introduce-patient- assurance-program-to-cap-out-of-pocket-costs-at-25-per-30-day-insulin-prescription. [FN3] . “Successful Prescription Drug Discount Program Expands to Benefit More Consumers at Point-of-Sale,” March 12, 2019, available at: https://www.optum.com/about/news/successful-prescription-drug-discount-program.html. [FN4] . Juliette Cubanski, Matthew Rae, Katherine Young, and Anthony Damico, “How Does Prescription Drug Spending and Use Compare Across Large Employer Plans, Medicare Part D, and Medicaid?” May 20, 2019, available at: https://www.kff.org/medicare/issue-brief/ how-does-prescription-drug-spending-and-use-compare-across-large-employer-plans-medicare-part-d-and-medicaid/. [FN5] . Devon Mahieu, “Meijer's Free Prescription Drug Program hits milestone with 50 million prescriptions,” July 16th, 2019, available at: https://upnorthlive.com/news/local/meijers-free-prescription-drug-program-hits-milestone-with-50-million-prescriptions. [FN6] . “Reforming pharmacy benefit manager practices may lead to drug cost savings,” June 21, 2019, available at: https:// www.sciencedaily.com/releases/2019/06/190621140356.htm. [FN7] . “FTC Staff Issues FY 2016 Report on Branded Drug Firms' Patent Settlements with Generic Competitors,” May 23, 2019,” available at: https://www.ftc.gov/news-events/press-releases/2019/05/ftc-staff-issues-fy-2016-report-branded-drug-firms-patent. [FN8] . Richard G. Frank, Andrew Hicks, Ernst R. Berndt, “The Price to Consumers of Generic Pharmaceuticals: Beyond the Headlines,” NBER Paper No. 26120, July 2019, available at: https://www.nber.org/papers/w26120. [FN9] . “ACP Addresses High Cost of Prescription Drugs in New Policy Papers,” November 12, 2019, available at: https://www.acponline.org/ acp-newsroom/acp-addresses-high-cost-of-prescription-drugs-in-new-policy-papers. [FN10] . “Klobuchar, Grassley Continue Bipartisan Legacy of Senator McCain, Reintroduce Legislation to Import Less Expensive Prescription Drugs from Canada,” January 10, 2019, available at: https://www.klobuchar.senate.gov/public/index.cfm/news-releases?ID=E169B21A-7C9F-4568-AAE8-4B4E3AAC6372. [FN11] . “Report to The Vermont Legislature, Wholesale Importation Program for Prescription Drugs Legislative Report,” Vermont Agency of Human Services, January 3, 2019, available at: “https://nashp.org/wp-content/ uploads/2019/01/Report-to-VT-Legislature-on-Rx-Wholesale-Importation-1_3_2019.pdf.” [FN12] . “Baker Seeks Savings on Prescription Drugs,” January 14, 2019, available at: https://www.senatorbaker.com/2019/01/14/baker-seeks-savings-on-prescription-drugs/. [FN13] . “Senate Co-Sponsorship Memoranda,” January 8, 2018, available at: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -17- https://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=S&SPick=20190&cosponId=27531. [FN14] . “Governor Ron DeSantis Announces Plan for Prescription Drug Importation Program,” February 20, 2019, available at: https://www.flgov.com/2019/02/20/governor-ron-desantis-announces-plan-for-prescription-drug- importation-program/. [FN15] . “Assemblymember Wood and Attorney General Becerra Announce Bill to Outlaw “Pay for Delay” Tactics of Drug Companies,” February 20, 2019, available at: https://a02.asmdc.org/press-releases/20190220-assemblymember-wood-and-attorney-general- becerra-announce-bill-outlaw-pay. [FN16] . “Attacking High Cost Of Prescription Drugs,” February 28, 2019, available at: http://www.housedems.ct.gov/scanlon/article/attacking- high-cost-prescription-drugs. [FN17] . “Prescription Drug Cost Reduction Measures,” https://leg.colorado.gov/bills/hb19-1296 HB19-1296. [FN18] . “FTC Charges Surescripts with Illegal Monopolization of E-Prescription Markets,” April 24, 2019, available at: https://www.ftc.gov/news-events/press-releases/2019/04/ftc-charges-surescripts-illegal-monopolization-e-prescription. [FN19] . “Yost Joins Lawsuit Against 20 Generic Drug Manufacturers in Conspiracy to Fix Prices for More Than 100 Generic Drugs,” May 13, 2019, available at: https://www.ohioattorneygeneral.gov/Media/News-Releases/May-2019/Yost-Joins-Lawsuit-Against-20-Generic- Drug-Manufac. [FN20] . “Attorney General Moody Files Major Antitrust Action Against Generic Drug Companies,” May 13, 2019, available at: http:// www.myfloridalegal.com/newsrel.nsf/newsreleases/25544B6CAD3C1A6D852583F9004B25C3. [FN21] . “Governor Mills Signs Into Law Comprehensive Prescription Drug Reform Package,” June 24, 2019, available at: https:// www.maine.gov/governor/mills/news/governor-mills-signs-law-comprehensive-prescription-drug-reform-package-2019-06-24. [FN22] . “Attorney General Becerra Secures Nearly $70 Million against Several Drug Companies for Delaying Competition and Increasing Drug Prices,” July 29, 2019, available at: https://oag.ca.gov/news/press-releases/attorney-general-becerra-secures-nearly-70-million-against- several-drug. [FN23] . “Congressman Joe Morelle Sponsors Legislation to Lower the Cost Of Prescription Drugs,” October 4, 2019, available at: https://morelle.house.gov/media/press-releases/congressman-joe-morelle-sponsors-legislation-lower- cost-prescription-drugs. [FN24] . “Governor Gavin Newsom Signs Legislation Banning “Pay for Delay” to Fight Runaway Prescription Drug Costs,” October 7, 2019, available at: https://www.gov.ca.gov/2019/10/07/governor-gavin-newsom-signs-legislation-banning-pay-for-delay-to-fight-runaway- prescription-drug-costs/. [FN25] . “Brindisi Provides Bipartisan Solution to Bring Down Drug Costs for Americans,” October 11, 2019, available at: https:// brindisi.house.gov/media/press-releases/brindisi-provides-bipartisan-solution-bring-down-drug-costs-americans. [FN26] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -18- . “U.S. House Votes 403-0 to Pass Spanberger's Bill to Help Lower Drug Costs for Central Virginia Seniors & Families,” October 29, 2019, available at: https://spanberger.house.gov/news/documentsingle.aspx?DocumentID=2197. Produced by Thomson Reuters Accelus Regulatory Intelligence 05-Feb-2020 © 2020 Thomson Reuters. No claim to original U.S. Government Works. -19-