50th Anniversary of Thalidomide Nightmare and Follow-up Legislation

This year marks the 50th anniversary of two monumental events in the history of regulatory medicine.

First there was the worldwide realization that thalidomide, a drug doctors in Europe, Canada and elsewhere were giving to their pregnant patients to relieve morning sickness, was in fact causing thousands of cases of birth defects.

US Not Safe

Initially, politicians thought they had managed to avoid the thalidomide nightmare in the United States. This was largely due to the refusal of FDA medical officer Frances Kelsey, Ph.D., M.D., who turned down the manufacturer William S. Merrill's request to sell the drug in the US. Kelsey was unconvinced of the data.

That was in 1959. When the panic hit in 1962, regulatory agents thought the US was in the clear only to learn that William S. Merrill had quietly distributed thalidomide to 1,200 US doctors. The hunt uncovered much of the distributed drug but not before as many as 17 children were born with birth defects attributed to thalidomide.

Source: FDA Consumer Health Information

Kennedy Legislation

In response, later that same year President John F. Kennedy signed landmark legislation known as the Kefauver-Harris Amendments.

Sponsored in Congress by Sen. Estes Kefauver (D-Tenn.) and Rep. Oren Harris (D-Ark.), the Kefauver-Harris Amendments were amendmants to the Federal Food, Drug and Cosmetic (FD&C) Act, and they acted as a framework in which drug manufacturers were required to prove scientifically that a medication was not only safe, but effective.

Scientific safeguards were established and contiue to be used today by the FDA to ensure that consumers will not be the victims of unsafe and ineffective medications.

Impact

According to FDA Commissioner Margaret Hamburg, M.D., the 1938 FD&C Act had serious shortcomings, notably that it was legal for drug manufacturers to sell their product if the FDA simply had not acted within 60 days to prevent the company from beginning to market the product.

Furthermore the FDA lacked any authority whatsoever in the enforcement of the manufacturing process.

Said Hamburg, "With the passage of the amendments, FDA was no longer a helpless bystander while unproven medicines were streaming into pharmacies and onto patients' bedside tables."

Source: FDA Consumer Health Information

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