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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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  • Too bad we don’t have any smart people without financial or ideological incentives to look at these regulations in a scientific manner. In Post Fact, Post Science America, there won’t be any objective evaluation of these regulations. We have gone rogue, the lunatics are running the asylum. These regulations were necessary, but industry money and industry insiders now running our FDA and other agencies, won’t even count the dead! They have already done away with device industry, and marketing regulations, leading to countless deaths.

    • Even though many folks have financial or ideological incentives to overlook this data, they may be likely to feel that the loss of 5+years of their lives is worth reconsidering the risk/benefit ratio of these regulations. We are all affected adversely by the 1962 amendments, including those who think they profit by them.

    • Both you, Mavis, and Karen have called attention to the huge conflict of interest that the FDA now has. Somewhere in the neighborhood of 70% of the salaries of examiners come from the “user fees” paid by the drug companies. This started when the 1992 Prescription Drug User Fee Act was passed, which allowed drug companies to pay $100,000 to the FDA for a faster review time. The FDA was hired more examiners with that money. In 2016, the user fee was about $2.4 million. This Act has indeed shaved about a year off of the 14 year development time, which saved many lives. However, when the FDA’s David Graham expressed concern about Vioxx just before its approval, he was told the the FDA’s client was now the drug industry. Sadly, few ethicists seem even to have noticed this huge conflict of interest.

  • This is a very good introduction to Dr. Ruwart’s latest book, “Death by Regulation…”. The unintended consequences of the FDA’s regulatory requirements are clearly demonstrable as shown throughout her book. In spite of the good intentions of the FDA at that time, a re-examination by the FDA of the economic and health impacts is overdue. The Trump administration has put into place actions to remove stifling regulations by the EPA – perhaps it should consider similar actions with the FDA. Time will tell.

    • Loved your comments Mike & Mavis!! The people running the FDA have gotten so out of hand…perhaps their intentions in 1962 were noble….however, I believe that the MIGHTY DOLLAR has taken control. And that is a huge hurdle to overcome with sensible, logical, rational & ethical thought.

  • Thank you Dr Ruwart for informing us on this amendment. I don’t think the average American thinks about how regulations that have been in place for decades affects medicine today. This is a must-read for everyone!!

    • You and Mavis are right about the control of the FDA. In 1992, the Prescription User Fee Act allowed drug companies to pay $100,000 to get a faster review of their data when they applied for approval. In 2016, the user fee was $2.4 million, which supplies about 50-70% of the salaries of the reviewers. Consequently, when FDA’s Dr. David Graham expressed concern about Vioxx’s side effects just before it was approved, his supervisor told him that the FDA’s client was the pharmaceutical industry. This is a huge conflict of interest for the FDA, yet sadly few ethicists seem to notice.

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