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In an unexpected move, the Food and Drug Administration is reversing a decision by the Trump administration to end a controversial program that forces drug makers to win regulatory approval for medicines already on the market, but were never actually approved.

At issue is the Unapproved Drugs Initiative, which was launched in 2006 to gather data on numerous medicines that had been available for years on a grandfathered basis because they predated stricter approval requirements. But the program prompted complaints that some companies established monopolies after winning approval for a drug that, in some cases, led to big price hikes or shortages.


In explaining its decision last November, the Department of Health and Human Services pointed to such concerns as evidence that the program may have had “laudable goals,” but created “unintended consequences” that yielded “very limited benefits.” The agency also claimed a third-party analysis indicated billions of dollars would be saved by ending the initiative.

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