STAT+: FDA spikes a drug approval program that inadvertently led to price hikes and shortages
After years of mounting criticism, the federal government is planning to end a controversial program that forces drug makers to win regulatory approval for medicines already on the market that weren never actually approved.
The Unapproved Drugs Initiative 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. More recently, the initiative generated complaints that some companies established monopolies after winning regulatory approval for a medicine, which in turn, led to big price hikes or shortages in some cases.
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