New FDA Commissioner Nomination Soon?
Washington rumors, so far unconfirmed, are that Jane Henny, M.D., may be nominated to become the next commissioner of the U.S. Food and Drug Administration. Dr. Henny, currently at the University of New Mexico, is a cancer researcher who was formerly a deputy commissioner at the FDA. She is largely unknown to the AIDS community.No matter who is nominated, AIDS activists and organizations need to pay attention to the process of selection and installation of a new commissioner. We need to understand and agree on what our major interests are, be aware of the Senate confirmation process, and build relationships with the new commissioner.
Here are some of the issues we have heard in talking with AIDS activists who are familiar with what is happening in Washington:
The new FDA reform law calls for expansion of clinical-trials information services to include all serious or life-threatening diseases--a change which AIDS organizations strongly support. The AIDS clinical trials information system has worked very well; the concern now is that instead of building on this model, the older cancer model may be chosen instead. It lists only government trials, and in other ways, too, gives less information to patients.
The phase IV (post-marketing) clinical trials, which companies agree to do in return for earlier approval, need to be monitored and followed up.
The new reform law calls for a fast-track system for early approval of important drugs, based on the current accelerated approval and expanded access mechanisms in AIDS--a change everyone supports. There will be many details and specifics in setting up this system, and because early access is so important to people with AIDS, our community should be involved when these specifics are decided.
The FDA needs to continue pressuring companies to determine pediatric doses for important drugs.
Now is the time to further discover and develop our consensus around these and other FDA issues, so that we can present our concerns effectively at this critical time. Hopefully the AIDS community will continue to have access to the commissioner's office, as it did under former commissioner David Kessler, M.D.
