Kefauver-Harris Amendment Essay Example | Topics and Well Written Essays - 500 words

Kefauver-Harris Amendment - Essay Example 127-128). The communal protest caused by the Thalidomide calamity near the beginning of 1960s hastily directed to the road of new set of laws and an unusual sentiment regarding untried drugs. In an attempt to stop happening one more analogous tragedy at the rear of the Thalidomide mishap, the U.S. Parliament, in 1962, passed the Kefauver-Harris Drug Amendment, ordering austere controls on drug checking, promotion and selling. The edict asserted for the first time that hottest drugs must be made known to be helpful before being advertised. In addition, it proposed stringent regulations for sound engineering practices, the intention being to augment quality control in the manufacturing route. The new codes would step up to transform not only the approach Americans participated in drug experiments but also their anticipations for the safety of drugs approved by the U.S. Food and Drug Administration. Kefauver-Harris Drug Amendment conceded collectively by the Congress to strengthened control over recommended and unproven drugs and to make certain greater drug protection. It was acknowledged that no drug is actually harmless unless it is also effectual. Before publicizing a drug, its manufacturers now had to demonstrate to FDA not just safety, but also provide considerable verification of effectiveness for the product's future utilization -- a milestone proceed in medical record.