Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

What followed has been described as a test of wills. Merrill had tons of the drug in warehouses ready for sale and had given samples to 1,000 American physicians. Dr. Kelsey was aware of accumulating reports of birth defects associated with it. Despite increasing pressure from Richardson-Merrill for approval, she repeatedly asked for more safety data, all of which she found insufficient.

In November 1961, more conclusive evidence from Europe emerged that linked the drug to severe fetal malformations, most commonly affecting the limbs but also involving the ears, eyes, esophagus, and intestines. Richardson-Merrill subsequently withdrew its application and recalled the samples. It is estimated that during its time on the market elsewhere in the world, thalidomide caused deformities in more than 10,000 babies, an estimated 40% of whom died within a year of birth. Only about 40 thalidomide deformities were reported in the United States from the samples Merrill had distributed.

For her vigilance, Dr. Kelsey received numerous honors and awards. She was also called to testify before Congress on legislation to strengthen drug safety oversight. The Kafauver-Harris Amendments of 1962 updated the Food, Drug and Cosmetic Act of 1938 (FDCA) to abolish the 60-day time limit for FDA reviews and require animal testing before human trials can begin, among other measures. It also added efficacy to safety as a criterion for approval.

Congress is currently reevaluating the speed of FDA drug reviews in the form of the 21st Century Cures Act. That law would add billions of dollars in new funding for the National Institutes of Health to stimulate new drug development and streamline the FDA review process to get those drugs to market faster. The House passed a version of the law in July, and the Senate will soon consider it.

Perhaps this would be a good time for Congress to reconsider Dr. Kelsey’s lesson. The FDCA, which first mandated premarket review, followed a 1937 tragedy in which an antibiotic preparation for children, elixir of sulfanilamide, killed 107 people. The Harris-Kefauver Amendments followed America’s near miss with thalidomide. In each case, Congress resisted the allure of rushing innovations to market before they had been adequately vetted.

Frances Kelsey taught us that bureaucracy can save lives. Let’s hope we don’t some day need a Cures for the 21st Century Cures Act to protect us from a reduction in bureaucratic safeguards. Bureaucracy can be frustrating, but is can also be a crucial tool in safeguarding public health.

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About Robert Field

Robert Field is a nationally recognized expert in health care regulation and its role in implementing public policy. He holds a joint appointment at Drexel's schools of law and public health. He is also a lecturer in health care management at the Wharton School of the University of Pennsylvania and a senior fellow of Penn’s Leonard Davis Institute of Health Economics. Professor Field is the author of "Mother of Invention: How the Government Created 'Free-Market' Health Care," and of "Health Care Regulation in America: Complexity, Confrontation and Compromise," both published by Oxford University Press. He also writes and edits a blog on health policy for the Philadelphia Inquirer called the Field Clinic.