Fact Check-FDA did not approve thalidomide for pregnant women in 1950s or 1960s

This article has been updated to include a name.

Social media users are falsely claiming that the drug thalidomide was approved by the Food and Drug Administration (FDA) in the 1950s or 1960s.

Thalidomide was marketed internationally to pregnant women in the late 1950s and early 1960s as a treatment for morning sickness. Horrifically, it killed an estimated 80,000 children around the world before they were born, and 20,000 more who survived were born without limbs, with severe nerve damage and an array of other ailments.

Examples of the false claim that the FDA approved the drug can be seen here and here .

Some posts show a now-deleted tweet (archived: ) by Billy Prempeh, Republican candidate for New Jersey’s 9th congressional district, that reads: “Thalidomide was given to pregnant mothers in the 50s and 60s to treat nausea. The result? Severe birth defects. The FDA approves lots of unsafe things. This is about profit not health. Do your due diligence. But hey, what do I know? I’m just some guy named Billy. #TrustFauci”

The FDA never approved the drug thalidomide for use in the 1960s. An article on their website (here) tells the story of how Frances Oldham Kelsey helped stop the application for the drug due to what she saw to be inadequate scientific and safety data.

Kelsey reviewed applications for new drugs, which was a legal requirement to demonstrate safety by drug manufacturers before they went on the market. At the time, the FDA had a 60-day period to reject the application (here).

Thalidomide, developed by the German firm Gruenenthal, was withdrawn from the West German market on Nov. 27, 1961 (here).

A Cincinnati company called William S. Merrell tried to bring thalidomide to the U.S. under the brand name “Kevadon” after it had already been in use by more than a dozen countries.

According to the University of Chicago Medicine (here), Kelsey initially reacted to the thalidomide application filed by William S. Merrell by saying: “It was just too positive; this couldn’t be the perfect drug with no risk.”

Dr. F. Ellis Kelsey, her husband and a pharmacologist at the National Institutes of Health at the time, called one section of the application “an interesting collection of meaningless pseudoscientific jargon apparently intended to impress chemically unsophisticated readers.”

Kelsey saw a letter in the British Medical Journal in which a physician had reported cases of peripheral neuritis, which causes nerve damage in hands and feet, and requested proof from the Merrell company that the drug would not harm a fetus.

William S. Merrell was persistent that this (among other concerns) could be remedied by a warning label on the drug. Meanwhile, reports of increases in birth defects came from Europe and Australia. Kelsey had already rejected the company’s application four times and it finally rescinded its application on the fifth attempt.

The drug had unfortunately been given to around 20,000 Americans during the two clinical trials by Merrell, according to the New York Times and the Smithsonian Magazine ( here , here ).

Kelsey received the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy in 1962 for her work in protecting the public from the drug. The 1962 drug amendments bill passed that year to change drug regulation (here).

In 1998, the FDA approved thalidomide as a prescription drug for the treatment of myeloma and leprosy, with severe use warning labels for the drug here and here .


False. The FDA did not approve thalidomide for use in pregnant women in the 1950s and 1960s. The drug led to deaths and severe ailments in Europe and elsewhere.

This article was produced by the Reuters Fact Check team. Read more about our fact-checking work  here .