FDA Drug Approval--A Lengthy Process That Delays the Availability of Important New Drugs

Responsible for regulating the testing and marketing of all human drugs in the United States, the Food and Drug Administration (FDA) must ensure that the public health is protected by carefully assessing the risks and benefits associated with new drugs and making such drugs available to the public as soon as possible. The Federal Food, Drug and Cosmetic Act gives FDA the legal authority and responsibility for regulating and approving new drugs. The Act requires that FDA approve new drug applications (NDA's) within 180 days, or about 6 months after they are filed, or that FDA give an applicant notice of an opportunity for a hearing on the application's deficiencies. Where more time is needed, the Act permits the time to be extended by mutual agreement between FDA and the applicant. The GAO review of the FDA drug approval process consisted of: (1) obtaining the views and concerns of the drug industry, pharmaceutical associations, and other knowledgeable members of academia and FDA officials; (2) comparing drug approval procedures in Canada and eight European countries with those of the United States; (3) analyzing the FDA review process for selected NDA's; (4) analyzing the work load of FDA physicians, chemists, and pharmacologists involved in reviewing NDA's; (5) interviewing FDA reviewers of NDA's for their perceptions of the drug approval process; and (6) reviewing the FDA use of scientific and management information systems in its drug approval activities.