Drug Approvals

Frances (Oldham) Kelsey was born in British Columbia, Canada in 1914. Being very bright, she graduated from high school at age 15 and received her Bachelor’s degree when she was 20 and her Master’s at age 21. When she applied for the Ph.D. program in Pharmacology at the University of Chicago, she was mistakenly admitted. Her professor thought that Frances was a man’s name.

While a student at the University of Chicago, she identified a solvent that had caused the death of 107 people. This helped to spur the U.S. Congress to pass legislation providing oversight of food, drugs, and cosmetics.

She stayed at the University of Chicago after receiving her Ph.D. and began working on finding a cure for malaria.  It was during this time that she made a discovery that would later become a breakthrough in understanding an increase in birth defects. The discovery that she made was that some drugs being used passed through the placental barrier in pregnant women.

In 1960, Frances was hired by the FDA as one of very few physicians available to review drug approvals. One of her first assignments was to review the drug thalidomide which was being prescribed to prevent morning sickness. The drug had already been approved in over 20 countries.

Frances insisted that the drug be fully tested before it was approved. When the drug was tested, it was found to cross the placental barrier and cause serious birth defects. In countries where thalidomide had been approved, children were being born badly deformed.

Frances went from being scorned to becoming a heroine. But more important, legislation was passed in 1962 to strengthen drug approvals. What seems to be a no-brainer today was not in legislation until Frances had stood her ground on thalidomide approvals.

The legislation required:

  • Demonstrated effectiveness of drugs for their intended use.
  • A report on any adverse reactions.
  • Consent of patients participating in drug studies.

She received one of the highest awards given for civilian service in both the U.S. and Canada. She continued to work for the FDA until she was 90 (45 years). She passed away at the age of 101.

When we think of beginnings, we think of them as being associated with a definite date. The U.S. Congress had grudgingly passed legislation controlling the oversight of drugs. But this legislation was largely ineffective until Frances Kelsey’s refusal to approve thalidomide. Sometimes it takes a tragedy to provide a backbone for a true beginning.

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            “To us, she was always our heroine, even if what she did was in another country.” –  Mercédes Benegbi (a thalidomide victim)

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