Drug Regulation Changes
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New drug approvals based on safety AND efficacy
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Required GMPs and later GLPs
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New controls over Rx advertising
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New patient protection policies
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Retrospective reviews of drugs approved for safety alone between 1938-1960
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DESI Drug Review
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OTC Review
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Thalidomide led to some really significant changes, especially in drug regulation, not just in the US but around the globe as well. Thalidomide caused all countries with food and drug statutes to make similar measures to tighten control over the marketing of new drugs. And these new requirements were upheld by the US Supreme Court.
Drug Regulation Changes -- passage of the 1962 Kefauver-Harris amendments in the wake of the thalidomide crisis, required FDA to approve new drugs that were not only safe, but effective as well. In order to do that, FDA began to set standards for the manufacturing and testing of new products as a guide to "good manufacturing" and "good laboratory" practices, known as GMP and GLP regulations. FDA acted with new authorities to ensure the accuracy and adequacy of prescription Rx advertising. Under the Act, it also instituted some of the earliest government assurances that patients who participated in clinical research trials would be protected.
Finally, one of the most important provisions of the law was the provision for the retrospective review of drugs--both over-the-counter (OTC) and Rx (DESI)--that had been approved between 1938 and 1960 for safety alone. Many ingredients, such as hexachlorophene, disappeared from products on drug-store shelves, while many prescription drugs also disappeared, making way for a whole new generation of pharmaceutical products that were truly effective. Some of these include better heart and blood pressure medications, new anti-depressants, and a whole host of drugs that are now recognized as indispensable in the modern practice of medicine as witnessed by the government's new Medicare Prescription Drug Benefit program.