STAT+: FDA revives a controversial program the Trump administration ended over ‘inaccuracies’

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.

Continue to STAT+ to read the full story…