FDA program unintentionally causes price hikes

Several drugs — medicines that are on the market, ready to be prescribed — are still unapproved. That’s because they came into being before the current regulatory practices were set in place — so they were simply grandfathered in, without much scrutiny. The FDA, in response, launched the Unapproved Drugs Initiative back in 2006, in an attempt to make sure that many of these older drugs are indeed safe and effective.

But it’s come at a cost, STAT’s Ed Silverman writes. Such intense examination of decades-old drugs has prompted many companies to quit manufacturing them — allowing others to gain a monopoly and charge sky-high prices. A new study shows that just four such examples could add $20.3 billion to U.S. health care spending.