The New Drugs, Reports of Information for Drug Effectiveness Federal Register notice (July 9, 1966) provides historical information. Drugs classified as lacking substantial evidence of effectiveness and those identical, related or similar to it can no longer be marketed and are subject to enforcement action as unapproved new drugs. If a hearing request is denied or if no hearing is requested, FDA publishes its final determination in the Federal Register withdrawing FDA approval due to lacking substantial evidence of effectiveness. The agency considers these requests and either grants or denies it. If FDA’s final DESI determination classifies a drug as lacking substantial evidence of effectiveness, the agency will provide notice of an opportunity for a hearing.After FDA approves the application, the drug’s regulatory status is the same as any other drugs approved by FDA for safety and efficacy and is no longer considered part of DESI.
Drugs marketed as identical, related or similar to a DESI drug that FDA classified as effective require either an approved NDA or abbreviated new drug application (ANDA), as appropriate, to be marketed. Medicines with a new drug application (NDA) approved before 1962 only for safety require an approved supplement to the original application if found to be effective under DESI.
The amendment required FDA to evaluate the effectiveness of the drugs the agency had approved only for safety between 1938, when Congress enacted the FD&C Act requiring new drugs be shown safe prior to marketing, and 1962. FDA’s administrative process to consider the effectiveness of drugs that had been approved only for safety between 19 is called the drug efficacy study implementation (DESI).Ĭongress amended the Federal Food, Drug, and Cosmetic Act in 1962 to require that new drugs be shown effective, as well as safe, to obtain FDA approval.