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Considers S. 1552 and companion H.R. 6245, the Drug Industry Antitrust Act, to amend the Federal Food, Drug, and Cosmetic Act and Sherman Antitrust Act to establish drug company licensing procedures, to require FDA to certify the effectiveness of all new drugs, to require advertisements sent to physicians to contain FDA warnings on the drug, and to limit drug company rights to exclusive production of patented drugs.
Considers S. 1552 and companion H.R. 6245, the Drug Industry Antitrust Act, to amend the Federal Food, Drug, and Cosmetic Act and Sherman Antitrust Act to establish drug company licensing procedures, to require FDA to certify the effectiveness of all new drugs, to require advertisements sent to physicians to contain FDA warnings on the drug, and to limit drug company rights to exclusive production of patented drugs.
Committee Serial No. 32. Considers legislation to eliminate anticompetitive practices in the patenting, licensing, and marketing of drugs, and to require FDA standardization of drug names and stricter safety and efficacy standards for new drugs.
The amendments are also known as: Kefauver-Harris Drug Amendments.
Considers S. 1552 and companion H.R. 6245, the Drug Industry Antitrust Act, to amend the Federal Food, Drug, and Cosmetic Act and Sherman Antitrust Act to establish drug company licensing procedures, to require FDA to certify the effectiveness of all new drugs, to require advertisements sent to physicians to contain FDA warnings on the drug, and to limit drug company rights to exclusive production of patented drugs.