The Food and Drug Administration today announced new drug approval procedures to speed development of treatments for life-threatening diseases like AIDS. In essense, the new regulation would create a mechanism for the FDA to work with drug companies in the earliest stages of a drug's development to refine preliminary tests in animals and humans to get the most useful data in the shortest possible time. While that clearly could shorten the approval time for drugs that subsequently prove to be safe and effective, in most cases it would require a larger financial commitment from drug developers long before they have any realistic assessment of whether the drug will eventually pan out and thus enable them to recover their research investment. FDA Commissioner Frank E. Young acknowledged at a news conference that the revised procedures would show results only if private pharmaceutical companies take advantage of new opportunities to get the FDA involved in earlier stages of drug development. The word ``may'' is scattered throughout the proposal, establishing clearly that it creates new options for drug companies rather than requirements in the drug approval process. The regulation is being published in the Federal Register as an ``interim rule'' with a 60-day public comment period, meaning it is effective immediately. Young said repeatedly that he did not want to ``overpromise'' the likelihood of dramatic changes in early development of drugs for AIDS, cancer and other life-threatening diseases. Nonetheless, he defended the agency against charges by AIDS activists that the new regulations are politically motivated to help the campaign of Vice President George Bush _ who has headed the Reagan administration's effort on easing regulatory red tape at the FDA and other federal agencies. Young pointed out that Bush and Massachusetts Gov. Michael Dukakis agreed at their first debate that they are in essential agreement on how to cope with the AIDS epidemic, including support for federal anti-discrimination to protect people carrying the AIDS virus. The FDA commissioner used two analogies in explaining his view of how the new regulations would work: as a college professor giving students a clear idea of the answers he was looking for on an essay test question, rather than leaving for the students to guess what was on the professor's mind; and of the agency being more like a baseball catcher _ ``helping call the signals'' _ rather than strictly as an umpire _ ``just calling safe and out.'' In simplified terms, the new procedures encourage drug developers to meet with FDA regulators when they are getting ready to go into Phase II testing _ after preliminary animal and human tests have established the safety of a drug. The idea is that the FDA would help the companies design studies specifically greared to answering the scientific questions about a drug that the agency considers most pressing. If that happens, and the Phase II tests clearly establish that the drug is effective, the final step before approval _ Phase III testing on reasonably large numbers of patients _ could be sharply curtailed or perhaps even bypassed. Emphasizing that the new procedures would be used only for drugs designed to treat life-threatening diseases where no effective therapy is available, Young said, ``a treatment could be approved even if some questions reamin to be answered by researchers.'' ``There might be questions about the very best way to use a drug, the lowest dose that was effective, for example,'' he said. ``Such questions could be studied after the drug was approved and would not delay its approval.''
