Tejal Somvanshi
In 1962, the FDA forced the withdrawal of thalidomide from the American market before the drug—already infamous in Europe for causing birth defects—could gain a foothold. Dr. Frances Oldham Kelsey, the agency’s reviewer, became the symbol of FDA vigilance. But a fresh examination of medical records, patient interviews, and declassified documents reveals what the government has long concealed: the number of American survivors may be far larger than the 17 cases officially acknowledged.
Gwen Riechmann, co-founder of USA Thalidomide Survivors, says researchers estimate between 100 and 150 survivors in the United States—more than five times the official count. Many were never diagnosed. Their shortened limbs, missing fingers, or other birth defects were logged simply as “birth defect” or “limb malformation.” The drug was sold under different brand names and often prescribed without clear labeling, meaning countless women never knew what they were taking.
If your mother took a sedative for morning sickness between 1959 and 1962, and you were born with shortened limbs or other structural abnormalities, you may be a thalidomide survivor—but official recognition remains elusive. The practical stakes are real. Survivors lack formal acknowledgment, access to specialized care tracking, or compensation frameworks that exist in other countries. The UK Thalidomide Trust supports 414 beneficiaries; Canada and Australia have established formal registries. The United States has not.
The reviewer who saved thousands — and the survivors the FDA forgot
The irony cuts deep. Kelsey’s decision to demand more safety data saved American babies from the worst of thalidomide’s effects. Yet that triumph created a blind spot: an assumption that the ban was effective, that the problem was solved. Internal FDA documents from the 1960s show agency officials debated investigating existing cases but ultimately deferred to the CDC, which never launched a systematic study.
Retired FDA historian John Swann notes the agency did not maintain comprehensive records of thalidomide cases discovered before withdrawal. “The assumption was that because we got ahead of the curve compared to Europe, we had been spared,” Swann said. “The assumption was wrong.”
Jennifer Vanderbes, author of “Wonder Drug,” a history of thalidomide, documented cases in which pregnant women were explicitly told by their physicians they had not taken thalidomide, even as their prescriptions prove otherwise. “It was a deliberate act of erasure,” Vanderbes said. “Doctors were protecting themselves and the drug companies.”
Congressional interest has begun to emerge. A pending bill, H.R. 5865, would mandate an accounting of thalidomide cases and establish a registry similar to those in other nations. The bill also ties thalidomide to broader FDA reform efforts, asking regulators why post-market surveillance for birth defects remained ad hoc for decades.
Women in their sixties and seventies report being told by doctors in the early 1960s that they had not taken thalidomide—that their medications were aspirin, antihistamine, or simple sedatives. Hospital records, when obtained, contradict those assurances. One survivor recalled being told by her doctor she was mistaken. “I believed him for forty years.”
How many survivors exist in the United States? We don’t know. The CDC never counted. The FDA never searched. Estimates from survivor advocacy groups cluster around 100 survivors, but the true figure could be higher. Without a registry, without systematic outreach, survivors age without formal recognition of their condition’s origin.
As survivors enter their senior years, the policy gap widens. Kelsey’s legacy—a more cautious FDA—remains intact and justified. But it has also enabled a different kind of failure: the disappearance of a population the system failed to protect and then failed to acknowledge. Fixing that requires not vindication of Kelsey’s decision, but a reckoning with what came after.
