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FDA's centennial anniversary

November 20, 2006 | A version of this story appeared in Volume 84, Issue 47

This is a response to the article on the Food & Drug Administration's 100th anniversary (C&EN, Sept. 18, page 15). I am a retired FDA chemist and current consultant to the pharmaceutical industry. I was employed at FDA for more than 25 years working in the human drug regulation program and was involved in the review of new drugs.

I believe that FDA now has the largest number of employees and the largest budget in its history. The article mentions "insufficient resources." Sadly, based on my past and current observations, FDA has adequate resources, but by its choice of operating and work processes, wastes them to a not insignificant extent. For example, it may at its own discretion expand its workload by taking on projects beyond its statutory mission, such as the tobacco issue during former commissioner David A. Kessler's tenure. As long as it chooses to undertake such "off-mission" activities, it will never have enough resources.

On the other hand, Congress has made FDA somewhat of a partner with the drug industry via user fees and requires it to review just about every application it receives. Thus the agency has gone, at least partially, from a regulator of the drug industry to a partner in its business enterprise with the advent of user fees.

The accelerated review process that came about by user fees has led to required studies being done in a postapproval fashion. Many of these studies are not started or finished in a timely manner by the industry. That is a disgrace. In the generic drug area, FDA continues to review applications for the same drug no matter how many are submitted or approved. What does the public get out of approval of the sixth or seventh "me-too" drug? Many Office of Generic Drug person-years of labor are wasted on such applications.

It is easy to be critical of FDA because it has many difficult responsibilities and does not perform evenly in meeting them. Criticisms by the Center for Science in the Public Interest are mentioned in the article. While I am, to an extent, a critic of FDA, there are many positive things to admire, two of which are the dedication and skill of most of FDA's employees.

Robert A. Jerussi
Fairfax, Va.



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