Kefauver-Harris Amendment 1962 - Introduction To Drug And Medical Device Regulation PDF

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Prachiti Vichare Diagnostic Writing Assignment Fall 2016 RGA 6100-03 Northeastern University

Kefauver-Harris Amendment 1962 Food, Drug and Administration was established for safe and effective use of medicines for the consumers. After its establishment, it underwent various alterations to protect consumer practices. In the year 1962, there was a devastating tragedy which involved a drug named Thalidomide, which was mainly used in Western Europe, for treating a condition of nausea associated with morning sickness, experienced during pregnancy. This incident had great detrimental effects on the nation. Thalidomide mainly caused birth defects in the new-born (i.e. Phocomelia-Limb Malformations). This occurrence further required immediate attention and thus Kefauver- Harris amendment came into the picture.1 Kefauver- Harris Amendment 1962 is an amendment of the earlier Food, Drug and Cosmetic Act 1938; which states that if the drug is to be marketed, the FDA should first approve the marketing application of known entity. The law also launches various other activities which involve practices like - investigation of new drugs, inspection of production facilities on regular basis; provide veracious information i.e. mentioning the side effects of the drugs that are to be

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published which can be done through proper advertisements; and all new rules should be strictly considered while marketing a new drug.2 FDA came into existence before 1962, but due to this amendment, its acceptance was augmented. People started believing the rules and regulations, trusted the department and also believed that it won’t provide false information that will threaten their regime. Furthermore, they felt protected. Now FDA’s drug development process is regarded as a “gold standard” that other countries aspire to match, says Douglas Throckmorton, M.D., deputy director of FDA's center for Drug Evaluation and Research.(3) Such enactment of law had a pronounced impact on the society that every other drug, thereafter, was provided with a proof of its safety and efficacy before its approval. The drugs now accessible in the market are both safe and efficacious to the patients for their indicated illness; somehow the law met its required objectives. REFERENCES 1) Kennedy, S. (2015, February 20). FDA Kefauver-Harris Amendment (1962). Retrieved September 23, 2016, from http://www.imarcresearch.com/blog/bid/361199/FDA-KefauverHarris-Amendment-1962; Kefauver-Harris Amendments Revolutionized Drug Development. (2012,

October).

Retrieved

September

23,

2016,

from

http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM322886.pdf 2) Meadows, M. (2006, January/February). Promoting Safe and Effective Drugs for 100 Years. Retrieved

September

23,

2016,

from

http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffecti veDrugsfor100Years/ 2

3) Kefauver-Harris Amendments Revolutionized Drug Development. (2012, October). Retrieved September

23,

2016,

http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM322886.pdf

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