The Kennedy version of the Drug Regulation Reform Act

Abstract

Provisions of Senator Edward Kennedy's version of the Drug Regulation Reform Act of 1979 (S.1075) are discussed. Included in the discussions are pre- and postmarketing approval controls on drug products, product equivalency, drug promotion and information, penalties, and the National Center for Drug Sciences. Provisions of the act are compared with the Carter Administration's 1978 (S.2775, H.R.11611 and H.R.12980) and 1979 (S.1045 and H.R. 4258) drug reform bills. The Kennedy bill does not depart radically from the existing drug approval process but would open it to the public and give FDA more flexibility to impose conditions, such as limited distribution and postmarketing surveillance, to product approval. It establishes drug compendia that would meet federal standards but that preferably would be published by the private sector. Hospitals and other health care institutions are exempted from the bill's patients package insert requirements, except as otherwise regulated by FDA.