September 19, 1973

Dr. Gerald D. Laubach
President

Pfizer Inc.

235 East 42nd Street
New York, New York 10017

Dear Dr. Laubach,

I am very grateful to you for taking time to reply by your letter
of August 23rd to my academic inquiries. I enjoy the opportunity to
read the material you sent me; perhaps inevitably it does not quite go
to the heart of the problem, namely the shrewdness of your own analysis
of the contingencies that a drug might face in the course of its
development.

The bereaucratic irrationalities of the FDA procedures have elicited
such an angry, emorional response among sowe of ay friends in the
pharmaceutical industry that I wondered whether this may not aleo have
clouded their judgment about making the most effective empirical adjustments
to the real situation. I was interested in developing a point of view
about the possible costs, as well aa conceivable benefits, that may sten
from the last decade pattern of FDA regulations. To the extent that the
industry fails to internalize the constraints, however irrational they may
be, that they may face in seeking drug approval they may continue to
make large investments in drug development without adequately anticipating
the actual problems they will face in seeking approval. I was simply
conjecturing that this might be a problem, and I was struck by the remark _
attributed to you by Business Week that your own batting average at Extwer /-/. .. 5
had been remarkably high. If so, this then means that you have policies
for eccommodating to the existing system which are pragmatically more
successful than applies to others. One might then argue that the social
cost of the regulatory framework is amplified by your less insightful
colleagues} failure to make the most efficient accomaodation to the real
world. Your remark that your "loss of candidates after completion of Phase II
clinical trials has been a rarity" probably does speak to a remarkable degree
of insight and judgment on your part. This being the case, it is easy to
sfapathize with your focus on irrational delay rather than inadequately
predicted refusal as your main problem with the agency.

Well, we might all be hopeful that there may be some change in the
texture of the FDA's bureaucratic process during the current period.
Certainly it is a very important policy consideration to focus on the issue
of bureaucratic implementation rather than the basic validity of the current
law as the major problem that you face. To that extent arguments like those
of Sam Pelzmann that we ought to do away with the FDA altogether are
probably really not very helpful.

Sincerely yours,

Joshua Lederberg
Professor of Genetics

JL/rr