Putting the Brakes on drug Approval: Adefovir

Patient access to HIV drugs in the Unites Stateshas been facilitated by an expedited ‘fast track’process of drug approval by the Food and DrugAdministration (FDA). Although this process cannever be ‘fast’ enough for the individual afflictedwith HIV, regulatory agencies bear the responsibilityto weigh the relative risks and benefits of approvinga drug for which both activity and safety informationmay be limited. It cannot be argued thatthe rapid approval of the protease inhibitors savedthe lives of thousands of HIV-infected individuals.And certainly, in retrospect, delaying the release ofthese drugs would have been foolish even knowingnow that the metabolic side effects of this class ofdrugs were underappreciated. The catalyst for therapid approval of drugs in the 90s was the overridingsentiment shared by patient advocates, industry,academics and government that there was adire urgency to provide access to effective treatments.