FDA Seeks Swifter Approval of Drugs for Some Life-Threatening or Debilitating Diseases

Abstract

THE FOOD AND DRUG Administration (FDA) is seeking to accelerate approval of drugs for patients with life-threatening or debilitating diseases. Obvious candidates are drugs against acquired immunodeficieny syndrome (AIDS) and anticancer treatments. The agency issued an interim rule, published in theFederal Register, that expands Phase II clinical trials to provide enough data on safety and efficacy of designated drugs to enable them to bypass Phase III studies and be considered for approval. Although there are provisions for comment on the rule, it actually took effect on the publication date a month ago. If the FDA staff considers it necessary, such drugs would continue to be monitored by a postmarketing surveillance system. This will be decided on a case-by-case basis. To further speed the approval process, the agency will convene advisory committees as needed to consider the data from the expanded Phase II studies. Studies ready for consideration thus won't