In 2006, the Food and Drug Administration launched a program to require drug makers to win approval of medicines that — believe it or not — were being sold without the agency’s imprimatur or remove them from the market. At the time, hundreds of treatments were readily available because some companies failed to comply with a 1962 law mandating companies prove drugs were effective.
Unfortunately, the FDA effort has had some unforeseen consequences.
More medicines may have received needed regulatory approval, but often enough, shortages ensued, prices rose, and there was no new clinical evidence to support the vast majority of the medicines that were approved, according to a new study published in the Journal of Managed Care & Specialty Pharmacy.
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