Apparently the Thalidomide scandal is what prompted the FDA to be legislated?
But they still obviously can also make mistakes.
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The scandal briefly flared in the United States, where the drug was given to about 20,000 Americans in loosely run clinical trials sponsored by two American drug makers. The crisis led to passage of modern drug safety laws in the United States that required pharmaceutical companies to prove their medicines worked through rigorous clinical trials.
But the babies whose mothers took thalidomide in the United States were largely forgotten. Today, more than half a century later, people who believe they are the U.S. survivors of thalidomide have found one another through Google searches and Facebook groups, joining forces to fight for justice, recognition and compensation.
Historians say the lesson of thalidomide is one that society is still learning the hard way. Hundreds of thousands of Americans have died in an opioid epidemic that has its roots in the Food and Drug Administration’s approval of the painkiller OxyContin and
dishonest, aggressive marketing of the drug by its maker, Purdue Pharma.
Today, as the coronavirus circles the globe — claiming thousands of lives — there is a renewed push to rush potential cures to market, even if it means bypassing the checks and balances that were thalidomide’s legacy.
Jennifer Vanderbes, who is researching a book about the history of thalidomide in the United States, said society owed the survivors in America a debt of gratitude.
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The U.S. was supposed to have escaped the devastation of a drug that caused birth defects in babies overseas. This is the almost forgotten story of its toll in America.
www.nytimes.com