The FDA's identity crisis

On its hundredth birthday, the Food and Drug Administration is having a bit of an identity crisis. The FDA has long been conflicted as to whether it is primarily a regulatory or a scientific entity, said Peter Barton Hutt, former chief counsel for the administration, at yesterday?s FDA Centennial Conference in Philadelphia. In fact, it was the subject of what Hutt called "one of the funniest congressional debates I?ve sat through" during his FDA tenure in the 1970s. Now, as various ?o

Ishani Ganguli
May 16, 2006
On its hundredth birthday, the Food and Drug Administration is having a bit of an identity crisis. The FDA has long been conflicted as to whether it is primarily a regulatory or a scientific entity, said Peter Barton Hutt, former chief counsel for the administration, at yesterday?s FDA Centennial Conference in Philadelphia. In fact, it was the subject of what Hutt called "one of the funniest congressional debates I?ve sat through" during his FDA tenure in the 1970s. Now, as various ?omics accelerate the growth and complexity of scientific research, acting FDA Commissioner Andrew von Eschenbach told a crowd of pharma reps, consumers, and his own employees, the administration needs to work hard to keep up its scientific image. No doubt its linkurl:recent pronouncement;http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html that linkurl:marijuana;http://www.the-scientist.com/article/display/23081/ has no proven medical benefits, in the face of millenia of the drug's use for such purposes and scientific evidence (as linkurl:reviewed;http://fermat.nap.edu/html/marimed/ by the...
s primarily a regulatory or a scientific entity, said Peter Barton Hutt, former chief counsel for the administration, at yesterday?s FDA Centennial Conference in Philadelphia. In fact, it was the subject of what Hutt called "one of the funniest congressional debates I?ve sat through" during his FDA tenure in the 1970s. Now, as various ?omics accelerate the growth and complexity of scientific research, acting FDA Commissioner Andrew von Eschenbach told a crowd of pharma reps, consumers, and his own employees, the administration needs to work hard to keep up its scientific image. No doubt its linkurl:recent pronouncement;http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html that linkurl:marijuana;http://www.the-scientist.com/article/display/23081/ has no proven medical benefits, in the face of millenia of the drug's use for such purposes and scientific evidence (as linkurl:reviewed;http://fermat.nap.edu/html/marimed/ by the Institute of Medicine) to the contrary, contributes to this assessment in the public eye. But according to Steven Galson, director of the FDA Center for Drug Evaluation and Research, the main impediment is lack of funds. When asked what he would do if he received additional funding, Galson said his priority would be to "keep staff expertise commensurate with advances in science" and hire new experts in emerging fields like pharmacogenomics. Where would this money come from? Congressional funds for the FDA have long been stagnant. As Hutt, now senior counsel at the law firm of Covington & Burling, declared, "the FDA today is being starved to death by Congress and by the people of this country." An increase in user fees from pharmaceutical companies, already the FDA?s major source of funding, is the subject of linkurl:debate;http://www.the-scientist.com/article/display/23055/ as the next iteration of the Prescription Drug User Fee Act makes its way to Capitol Hill. But leaning more heavily on this source invites a host of criticisms about the FDA?s already seemingly cozy relationship with industry. So if the FDA intends to make a better case for itself as a scientifically driven agency, something has to give.

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