WASHINGTON - The FDA's administrative reform of its regulation of cancer therapies represents a public commitment by the agency to put into uniform practice measures that it has, for the most part, already implemented on an ad hoc basis, according to several senior managers of biotech companies with cancer therapies in the pipeline.

Although they welcomed the recent proclamations by President Clinton and FDA Commissioner David Kessler that the agency would transform its best practices into standard operating procedures, the industry executives told BioCentury that the tone of the announcements may be more important than the substance, and the most important audience might be FDA staff, rather than the patients and industry officials to whom they were ostensibly addressed.

Recalibrating risk

A change from the FDA's current tendency to a one size fits all, zero-risk tolerance policy to a policy that allows for higher risk quotients in the case of all life-threatening diseases, would be more important than any of the specific policy changes, they said.

If the attitudes Kessler expressed permeated the agency (see BioCentury, April 1), sponsors would see fewer bureaucratic impediments and patients and physicians would have more options for dealing with often fatal cancers for which there are no effective therapies. On the other hand, in the absence of such a cultural change, the "new" policies might have little impact.

Some executives are skeptical of Kessler's claims that FDA's decision to accept surrogate data, especially evidence of tumor shrinkage, will play a dramatic role in speeding the development of new cancer drugs. They pointed out that tumor shrinkage has been the basis of approvals for cancer therapies in the past, notably the approval of Taxotere for ovarian cancer, and the agency has accepted it as the primary end point in several ongoing Phase II and III trials for cancer therapies.