President Clinton recently directed the Food and Drug Administration to utilize new criteria in evaluating potential cancer treatments. This will allow for an expedited approval process and, it is hoped, facilitate the early access to life-extending drugs.
The Tribune’s article indicated the action was done in response to criticism that possible AIDS treatments were the only drugs getting the expedited FDA review.
But are cancer and AIDS the only two “politically correct” serious illnesses worthy of “special handling” by the FDA? Why are not drugs intended for treatment of those with all fatal or life-threatening diseases eligible for a prompt and efficient review?
As an individual with amyotrophic lateral sclerosis (ALS/Lou Gehrig’s disease), a fatal neurological illness, I am dependent, under current law, on the FDA and its extended and inefficient processes for approving any drug that may extend my life or be a cure. Despite the limited market ALS patients represent in comparison to cancer, a number of pharmaceutical companies are making progress in drugs that will make a real–life or death–difference to me. Those companies, and the many persons whose lives may be saved or extended by their products, deserve an FDA that acts to facilitate research rather than be the bureaucratic stumbling block. If the FDA cannot efficiently respond to all persons with serious illnesses, Congress should reform the entire process.
