The FDA's New Sheriff

Abstract

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 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). …