Is the FDA Working for Drug Makers or Drug Users?

Is the FDA Working for Drug Makers or Drug Users?
The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images
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The U.S. Federal Food and Drug Administration’s (FDA) origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. But its founding was not sufficient to prevent poor-quality food and medication from flooding the market. By 1938, in response to public outrage, Congress passed the Food, Drug, and Cosmetic Act, which granted the FDA increased authority in protecting U.S. consumers.

Early Success

Despite its shortcomings, the entirely taxpayer-funded FDA did once protect consumers. Rejecting the drug thalidomide is perhaps one of the most glorious examples of this protection. Thalidomide, used to treat morning sickness in pregnant women in the late 1950s, was approved by dozens of countries.
Dr. Frances Oldham Kelsey, one of only a handful of medical officers at the FDA at the time, was tasked with reviewing the thalidomide application. Despite constant pressure from the drug company, Dr. Kelsey refused to approve the application because she felt it lacked scientifically reliable evidence of the drug’s safety.
Xiaoxu Sean Lin
Xiaoxu Sean Lin
Ph.D.
Xiaoxu Sean Lin is an assistant professor in the Biomedical Science Department at Feitian College in Middletown, New York. He is also a frequent analyst and commentator for Epoch Media Group, VOA, and RFA. He is a veteran who served as a U.S. Army microbiologist and also a member of Committee on the Present Danger: China.
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