The Scientist : NewsBlog Print: The FDA's identity crisis

The Scientist: NewsBlog:

The FDA's identity crisis

[Entry posted at 17th May 2006 08:17 PM GMT]

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 recent pronouncement that marijuana has no proven medical benefits, in the face of millenia of the drug's use for such purposes and scientific evidence (as reviewed 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 debate 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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comment:

smoked marijuana vs vaporization

by Derek Rosenzweig

[Comment posted 2006-05-18 11:19:10]

The FDA claims that marijuana has no future as a "smoked" delivery system, but they fail to recognize the value of vaporization. From http://www.norml.org/index.cfm?Group_ID=6885 :

"Previous research by California NORML and others have demonstrated that cannabis vaporization suppresses many potentially harmful respiratory toxins by heating cannabis to a temperature where active cannabinoid vapors form (typically around 180-190 degrees Celsius), but below the point of combustion where noxious smoke and associated toxins (i.e., carcinogenic hydrocarbons) are produced (near 230 degrees Celsius)."

While more funding so they can do research is all well and good, but the research around marijuana has already been done. Since the 1950s when they first started doing real research, everything points towards marijuana having significant medicinal value. The simple fact is that they can't patent the chemicals that make marijuana active, and that is why they refuse to give it medicinal status. It all comes down to the greenback.

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PDUFA

by Merrill Goozner

[Comment posted 2006-05-18 11:19:01]

Users fees are not ipso facto bad. But the current Prescription Drug User Fee Act ties the user fees to a specific task: the review of new drugs. In a tax-constrained environment, industry fees could be raised without raising consumer hackles if the agency, through Congress, was free to determine the best way to spend the money. Beef up the agency's post-marketing surveillance system, create an independent safety assessment arm that was well funded and empowered to conduct its own research and trials, and the agency might have the political flexibility to hire new people with the latest skills for assessing new therapeutic approaches.

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