В 1960 году Фрэнсис Келси была нанята в FDA одним из 4-х специалистов, занимающимся в то время рассмотрением досье лекарственных препаратов для разрешения к продаже на территории страны. Одним из первых её заданий была заявка на разрешение продажи в США препарата талидомид (под торговой маркой Kevadon), поданная фармацевтической компанией Richardson-Merrell. Препарат позиционировался в качестве транквилизатора и болеутоляющего средства с показанием назначать препарат беременным женщинам при утреннем недомогании. Несмотря на то, что он уже был одобрен в Канаде и более чем в 20 европейских и африканских странах, Келси была обеспокоена некоторыми данными, свидетельствующими об опасных побочных эффектах у больных, принимавших препарат повторно. Испытывая серьёзное давление со стороны компании, она оттягивала одобрение препарата и просила проведения дальнейших клинических исследований для выявления вероятных побочных эффектов, в результате чего талидомид не поступил на рынок США. В ноябре 1961 года начали появляться сообщения из Германии и Соединенного Королевства, что матери, которые принимали талидомид во время беременности в настоящее время имеют детей с тяжелыми врожденными дефектами.
За блокирование распространения талидомида в США Келси была награждена премией за Выдающуюся Гражданскую службу.
Dr. Frances Oldham Kelsey — the pharmacologist whose bold stance against inadequate drug testing saved countless newborns from the perils of thalidomide, a drug which caused severe birth defects in over 10,000 infants — was born on this day in 1914. On her first month on the job at the U.S. Food and Drug Administration in 1960, the Canadian-born scientist resisted pressure from thalidomide’s manufacturer to quickly approve the drug, which was already being widely prescribed in Europe as a sedative for pregnant women experiencing morning sickness. As a result of Dr. Kelsey’s insistence on further safety testing, the drug was never approved in the United States, saving an untold number of children from its devastating effects.
When Dr. Kelsey started working at the FDA, she was part of a new generation of scientists who wanted to ensure that drugs were proven safe and effective before being marketed to the public. At the time, the FDA did not have the authority to enforce these requirements and pharmaceutical companies often engaged in minimal safety testing. It was even a common practice for companies to send new or experimental drugs to doctors for them to try out on their patients.
When Dr. Kelsey received the application from the Richardson-Merrell Company for approval of thalidomide, the company expected a fast approval since the drug was already in use in numerous countries including Germany, the UK, Canada, and Australia. Distrustful of the information provided by the company and, as she later explained, feeling that its representatives were «at no time being wholly frank with me» about the drug’s safety, Dr. Kelsey told the company further tests were needed. Over several months, the company continued to submit their application and Dr. Kelsey continued to reject it citing the need for additional tests.
Throughout this period, the company complained to her supervisors, contacted her repeatedly, and, as written in a 1962 Washington Post story, she «[lived] the while with insinuations that she was a bureaucratic nitpicker, unreasonable – even, she said, stupid.» Dr. Kelsey’s determined stance was vindicated eight months after the company’s initial filing when evidence from Europe showed that thalidomide was the cause of severe birth defects. In Germany alone, between 5,000 and 7,000 children were born without limbs or with flipper-like limbs, of which only 40% survived, and numerous cases emerged in other countries. In the US, fewer than 100 babies were born with thalidomide-related birth defects; the drug was never licensed in the US due to Dr. Kelsey’s efforts however a small number of pregnant women were exposed to it through samples provided to doctors from the drug company.
After news of the thalidomide disaster broke, there was huge public outcry for better drug testing and the U.S. Congress unanimously passed the Kefauver Harris Amendment in 1962 to strengthen drug regulations and gave the FDA enforcement authority. Dr. Kelsey was selected to help write the rules governing clinical trials — rules that have since been adopted throughout the industrialized world — and then oversee their enforcement as the chief of the Division of New Drugs.
On August 7, 1962, Dr. Kelsey became the second woman ever to receive the country’s highest civilian honor when President John F. Kennedy awarded her the President’s Award for Distinguished Federal Civilian Service. Dr. Kelsey’s far-reaching impact on science and drug testing was described by Harvard historian Daniel Carpenter as follows: «She had a huge effect on the science that we all take for granted today… She and the F.D.A. had a huge role in determining the terms and sequence of what is now modern clinical science.»
In 2005, Dr. Kelsey retired from the FDA at the age of 90 after 45 years of service and they established the Dr. Frances O. Kelsey Award to «celebrate courage and scientific decision-making» in her honor. This determined scientist, whose courageous actions helped save the lives of countless people, passed away in 2015 at the age of 101.