IN RECENT years growing dissatisfaction with existing federal drug law has been expressed by numerous groups. Physicians have complained of excessive delays in the introduction of new drugs and of growing intrusion by the Food and Drug Administration into the practice of medicine. The pharmaceutical industry has contended that resources are increasingly being shifted from productive research to administrative compliance.
Consumerists, a predominantly young, healthy, and cause-oriented group, have berated the FDA for not regulating industry and physicians more tightly, to general approbation in the news media and Congress. On the other hand, genuine respresentatives of patients and the sick themselves have recently moved in precisely the opposite direction. For example, in the case of valproate sodium, the Epilepsy Foundation of America strongly urged the FDA and Congress to accelerate approval of this valuable new drug for seizure control.1,2
Even more dramatically, cancer patients and their families have rejected