At the meeting, Kessler expressed his commitment to establishing a new approach for speeding access to important new drugs. An extensive legal and practical review was launched, with the goal of publishing a formal, written plan in the Federal Register to invite public commentary before final approval. Unfortunately, the frantic work involved in the ddI approval had to be done by many of the same FDA people, so the expected launch date of the new plan has been moved forward a number of times. The current expectation is that the plan will be published sometime in the fall of 1991. After a 45 day period for public comments, the plan may be revised if needed and made a formal part of FDA practice.
Strong views exist for and against the plan.
Many people have not yet taken a position since they haven't seen the plan itself. The plan would apply only to drugs needed for life-threatening illnesses, as defined in previous FDA policies. Clearly, this includes AIDS and HIV infection. It would permit full marketing approval after a drug's safety and dosage had been established and at the first evidence that it improved, to a statistically significant degree, the key surrogate markers of the disease for which it was intended. In HIV infection, this would mean markers such as the CD4 helper cell count or measures of the level of virus.