Ne MOT. ORD je tar on, a BAO RK. JAM eT, AD & Ph ates me hee wernt 604d WS be Oi, bee, OO, er Rue, aecree, Fe RIE ao, Ae ee ee CAMELS MEE, Sater ae, Om, MU, . ome COLES, OLA mri ©, Dhreeater, MM, yi C { D CO, ( { ~ @. { benny, Ooh, te, bererd HIE Gi MS 23 TLC m~) Let Cn m_ > VITCY Qg Les, une cases, THRM. . COM:MITTEE ON perteceses A We Cnet COVER NIMEMVAL AFFAIRS CL Ae SERRE CE CTOM _ cee count WASHINGION, OC. 20510 . ‘January 3, 1975 The Honoradie Elmer Staats Comporeoller General of the United States . , Washington, D. C. 20548 ‘Dear Mr. Staats: rs] n fo } | As you are aware, the Governmen irs and Human Re- sources Committees have active and 1 ding interests in the performance of the Food and Drug Administrat regulatexy policies. As you may recall, in 19 -=> Feairs Subcommittee on Executive Reorzanization and Government Researcn conducted an extensive investigation of the Food and Drug Administzaticn. A major focus of that investigation con- cerned Federal involvement in vaccine regulation, enc specific- ally, the performance of the Division of Biologic Standards (DBS) at the National Institutes of Health. As part of this investiga- tion, the General Accounting Office conducted 2 study entitled "Problems Involving Effectiveness of Vaccines.” As a result of these efforts, the role of the Federal Government in the regula- tion of vaccines was substantially changed, and the D835 was trans~ ferred to the Food and Drug Administration as the Bureau of Bio- logics (BOB). Over the past several years, the Human Resources Subcommittee on Health and Scientiric Research has held extensive hearings on vaccine policy. Both Committees are aware of the increasing evidence that there are still significant problems in the Federal Government's regulation of biologics. The swine fiu program, whatever its merits, resulted in a substantial loss in public confidence in the Federal Government's assurances 2s tO the safety and effec- tiveness of vaccines in general. It would be a tragedy if this lack of confidence translated into reluctance on the part of the public to take the many vaccines which have been clearly proven to be safe, effective and essential, such as measles, polio, rubella, mumps, tetanus, diphtheria, and whooping cough. a The Federal Covernment's swine flu program*raised many important questions relating to the Federal Government's efforts to ensure that the public is immunized against serious health threats. Your recent report dated June 27, 1977, entitled "The Kr i Peneean. An Manveandentes Venture in Preventive . The Honorable Elmer Staats - | . “January 3, 1978 Page Two ’ Medicine’ is an important first stcp in pointing out strengths and weaknesses of our Federal response to this perceived threat. As such, it is an important first step in restoring public con- fidence in the Federal public health establishment. However, we believe more work needs to be done. - It has been several years since the Bureau of Biologics _ began regulating vaccines from within the Food and Drug Admin- istration. In recent months, serious questions have again been raised about the effectiveness of BOB; therefore, on benalf of ‘both the Governmental Affairs and Human Resources Committees, we request that the General Accounting Office undertake a study -of the activities of the Bureau of Biologics, specifically answer- ing the following questions: : A. How useful and effective is the Bureau's adverse reac- tion reporzing system? To what degree are adverse reactions rioted by physicians, public health cfiicers and biclogics manu- facturezs' personnel reported to the BOB, and coes the system ensure that reported adverse reaction information is channeled to those who would be helped by receipt of this information? J rind B. How effective is the Bureau's program to regulate the informational content cf labels o£ biologics in general and vaccines in particular? C. How effective has the Bureau regulated .allergenics to ensure efficacy as well as safety, potency and purity? D. How reliable are the Bureau's biological test methods such as the CCA test for influenza vaccine, the neurovirulence test for polio, measles, and other vaccines and tests to detect viral contaminants in vaccin2s prepared in chicken eggs, chicken cell and other animal cultures, and in artificial media? E. How effectively does the Bureau examine vaccines and other biologics for trace metals and other extraneous materials and what: are the medical consequences of the presence of trace metals in biologics? . F. How effective is the Bureau's management in the follow- ing areas: 1. In maintenance and morale of individual staff members? 2. In maintenance of clear lines of authority in its decision-making activities? - ‘ * 1. “" . Vhe Honorable Eliuner Staats BO January 3, 1978— Page Three _ * 3. In its ability to provide for, ensure, and an take cognizance of dissenting opinions generated within ior ane without the Bureau; and ; . po 4, In the general administration of its responsi- bility to ensure safe, potent, pure and effective biologics? G. How is the Bureau now applying what was learned from ‘ the swine flu vaccination program in the isasles immunization area? H. What is the relationship between the research and con- ; trol functions of the Bur2au, and are most or. any of its research - activities more appropriate for concuct under the auspices of the National Institutes of Health? “ awe 2 - I. is there an adequate and tinely supply of vaccines available for use in the United States? What are the obstacles fo continued availability? How many firms.are involved in the mantufacrure of vaccines? Which vaccines are produced by only one or two companies? Is the continued availability of these vaccines assured or does it depend on certain conditions? What wo are they? J. What is the current state of the liability controversy with vaccines? How is liability handled tocay? What is the potential for liability questions threatening the continued availability of vaccines? i ? > K. Is adequate informed consent obtained when vaccines are , administered? When two forms of vaccine are available, as with the polio vaccine (live or killed), now is infermed consent hendled? What impact does this have on a company's liability? In addition, we request that the General Accounting Office look at the relationship between the Center for Disease Control, the National Institutes of Health, and the Food and Drug Admin- istration with respect to tneir mdividual roles in setting national vaccine policy. How well are they coordinating their efforts? Finally, we would like the General Accounting Office to investigate the professional relationships between those pro- fessionals working in any capacity to assist BOB in setting i various vaccine policies and the major pharmaceutical manu- facturers, To wnat extent do such relationships raise the possibility of real or apparent conflicts of interest? wee | ‘The Honorable Elmer Staats a January 3, -1978 - . Page Four estigation. Forward to a productive inv We are looking ration. Thank you for your coope With best wishes, Sincerely, (Hs i at $s Abe Ribicoft if LO sry ¢ . Harrison A. Williams Richard 5S. Schweiker