During my 19 years as a research scientist at the Upjohn Company, the regulatory burden imposed by the open-ended Drug Amendments Act of 1962 was mushrooming. My coworkers and I joked that because of this dramatic change to the mission of the FDA, made largely as a response to the European thalidomide crisis, we spent so much time meeting the FDA’s development demands that we had little time to discover new drugs.
Like most gallows humor, such comments masked the very real concern that instead of finding drugs that would save lives, we were checking regulatory boxes. We never dared to hint at these concerns in public for fear that the FDA might retaliate by dragging its feet to delay our company’s drug approvals.
The amendments gave the FDA the authority to require proof of effectiveness — not just safety — before approving a new drug. It could dictate which manufacturing standards needed to be met before animal testing, which animal tests needed to be done before clinical trials, and which human studies were needed for approval. The amendments also gave the FDA jurisdiction over advertising and labeling.
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