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The FDA's new sheriff.

David Kessler is that rare creature in cynical Washington: a hero. In the few months since he rode into town to head the beleaguered Food and Drug Administration, he has, for example, terrorized the food industry into using package labels that bear some relation to the contents, cracked down on misleading claims in the drug industry, and, of course, become a media star. He is also leading a revolution in drug testing and approval. The traditional clinical trial will never be the same, and nobody is sure whether that's good news or bad.

Among the reforms announced in November:

* Quicker approval for new drug applications, including a "fast-track" for drugs for life-threatening illnesses. Accelerated approval is supposed to reduce the time it takes to get new drugs to market, from the present ten years to an average of six. Fast-track drugs will move even more swiftly because companies can submit final data after the drug has been in use for a while. Kessler says that the agency agreed to trade approval time for increased ability to get a fast-track drug off the market quickly if problems turn up.

* External review of some new drug applications by outside contractors. Likely contractors include statistical research companies, universities, retired FDA and drug industry employees, and private physicians--and also new, private companies set up for this purpose. The agency is already selecting up to a dozen new drug applications for outside review.

* Accepting data from foreign studies in lieu of repeating the studies here. This may take some time to implement, because it requires bilateral discussions to establish reciprocal approval arrangements, development of common standards for clinical trials and a common format for applications, and a consensus on manufacturing practices.

The changes include an expanded role for institutional review boards, which are now to take sole charge of decisions to proceed with the earliest (Phase I) stage of clinical trials. Kessler also exacted a promise of more staff and money from the White House--although how that is to happen, given federal budget constraints, is not clear.

A populist revolt of sorts contributed to these steps. Consumer groups, especially gay activists, forced the agency to agree to greater speed and lesser insistence on safety when the drug is intended for a life-threatening condition like AIDS. But capitalism is behind the changes too. The pharmaceutical industry is delighted at the prospect of a shorter time to market. Federal and state government pressure to lower prices, plus escalating research and development costs, have been threatening the industry's sales levels ($175 billion a year worldwide) and its apparently recession-proof growth, rate (10 percent annually). The Administration says the new rules will reduce industry R&D expenses by $1 billion a year.

Many in Congress, however, are not pleased. Powerful Democrats complain that outside reviewers would undermine the agency's purpose, and want the changes delayed until Congress can study them. The Administration's response: Not a chance.

The new rules might be viewed with less suspicion if they had come straight from Kessler. But they didn't. They came from a report by the Council on Competitiveness. Nothing covert about the Council's purpose--"to ensure that federal regulations do not place unnecessary burdens on business"--nor about its desire to revamp drug approval, which has been one of the Council's highest priorities.

The Council was already in a shoot-out with legislators about its behind-the-scenes part in reducing other regulations, especially on the environment. Seeking documents from the FDA relating to the Council's role in the new drug rules, a House committee had to issue a subpoena before the agency agreed to turn them over. Kessler insists that many of the Council's recommendations actually originated at FDA.

Like other agencies, the FDA came out of the antigovernment Eighties demoralized and downsized, with drug research staff reduced by 28 percent. Yet between 1980 and 1989, Congress passed twenty laws expanding the agency's duties, and its new product applications grew 82 percent. Kessler, like other bureaucrats, was handed the challenge of doing more with less. His feisty style comes naturally, but he uses it consciously, to leverage his reduced resources. In his view, sounding as if he means business is a no-cost way of galvanizing FDA employees, filling them with a renewed sense of mission, while at the same time sowing fear (and reaping voluntary compliance) among the regulated.

But will this public stance distract attention from less obvious changes that actually ease regulations? Kessler's reverence for the FDA's purpose seems quite genuine. But suppose subsequent commissioners lack his commitment?

For the moment, however, Kessler is still in charge. Future targets: medical devices and conflict of interest. It is getting harder and harder to find expert investigators for drug studies who have no consulting ties or other interests in a drug, and conflict of interest also creates objectivity problems for advisory committees and IRBs. As for device review, says Kessler, that science is twenty years behind the times. What is not clear in all this is whether the new sheriff is saving the interests of the townsfolk or the cattle barons.

Tabitha M. Powledge is a Washington, D. C. science writer and editor.
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Title Annotation:Food and Drug Administration, David A. Kessler
Author:Powledge, Tabitha M.
Publication:The Hastings Center Report
Date:Jan 1, 1992
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