Federal Food, Drug and Cosmetic(FD&C) Act of 1938 did not accurately regulate drugs.  This Act allowed drug companies to sell a drug”if the FDA did not act within 60 days to prevent its marketing.” In addition,in 1938, the FDA did not have the autonomy to enforce good manufacturing orclinical practices.

During this time period, there were a lot of unsafe andineffective drugs in the market. Senator Kefauver’s investigation into thepharmaceutical industry revealed over-promotion of drugs and false advertisingof the side effects and efficacy of drugs in the market. One of the biggestdrug scandals at that time involved thalidomide. Thalidomide, if taken during the firsttrimester of pregnancy, would kill the fetus, cause the fetus to be blind,deaf, have digestive problems, have missing limbs, shortened limbs,missing/extra fingers or toes or webbed fingers or toes. Due to these sideeffects, thalidomide was not approved for use in the United States. FDA medicalofficer Frances Kelsey stopped the approval of the drug application due toinadequate safety data.

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Despite the disapproval, the William S. Merrill companyattempted to market Kevadon, a brand of thalidomide in the United States, and distributedthe thalidomide to various physicians. “There were 17 births of deformedinfants” because of thalidomide use in the United States. The FDA launched acampaign to recover the drugs to prevent further complications. Thalidomide thathad been approved and used in other countries resulted in thousands of childrenbeing born with birth defects. The Kefauver-Harris Amendment of1962, also known as the Drug Efficacy Amendment Act, was an amendment to theFD Act of 1938. This amendment was signed by President John F.

Kennedy onOctober 10,1962 with the help of Tennessee Senator Estes Kefauver and ArkansasRepresentative Oren Harris. The Kefauver-Harris Amendment changed the way newdrugs were approved and regulated. Before the Thalidomide tragedy, U.S.pharmaceutical companies were able to get their drugs approved by simply showingthe FDA their products were safe. However, now the companies would be required tofile a New Drug Application illustrating safety and effectiveness of the newproducts.

The FDA has 180 days to approve the application before a drug can bemarketed in the United States. Regular inspection of production facilities isalso required. Sponsors need to establish the efficacy of the drug and meet theFDA’s safety requirements, otherwise the drug will not be approved. Pre-1962 drugsthat were already on the market were tested for safety and effectiveness aswell under this amendment. Drug are required to go through multiple phases of clinicaltrials, called Phase I through Phase IV. Any adverse drug reaction also neededto be reported to the FDA. One additional effect of this change to the FD&CAct of 1938 was that it prevented cheap generic versions of drugs from beingmarketed as “breakthrough” drugs under new trade names.

Stricter controls of clinicaltrials were enforced by the FDA as well. The current good clinical practiceelements, that is, rules for clinical trials on human subjects, are in responseto the thalidomide incident in particular. These rules require, defined responsibilitiesfor the Principal Investigator in a study; Institutional Review Board oversight;monitoring of the clinical studies by the sponsor/manufacturer; informed consentfor participating subjects prior to dosing, approved study protocol; anexplanation for any deviation, documentation and record retention; and a testdrug or medical device control sample.   


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