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  • Agnieszka replied to the topic Thalidomide's Impact on Regulation and the FDA in the forum Introduction to Project Management 8 years, 7 months ago

    What the Thalidomide disaster did to the FDA was not only demonstrate the importance of drug trials, as Chris’s post pointed out, but, even more importantly, tightened surveillance on how these trials were conducted, their results, and the efficacy of the finished drug. Basically, it justified the need for rigorous regulation policies and practices. Unfortunately this meant that new drug development required several long years of testing before the drug could be released into the market. My follow up question is, do strict policies stunt medical innovation and economic growth? I am sure manufacturers and scientists confident in their development eager to see it be used think so.

    If the Thalidomide disaster never happened some other similar disaster would have occurred eventually and inevitably. However, if no such disaster would have happened to this day then Dr. Kelsey would have been out of a job, there would have been no Kefauver-Harris Act, and there would have been more deaths in America caused by unsafe, poorly tested drugs and devices. This would mean more time and money lost at removing these drugs and devices from the market (then redesign, reintroduction, and convincing consumers that they got it right this time), grievance lawsuits, and reimbursements to the victims. As an answer to my own question, stricter policies actually foster medical innovation and economic growth.