Back in 2006, the FDA launched an effort to force drug companies to win regulatory approval for medicines already on the market that actually were never approved. Numerous treatments had been available for years on a grandfathered basis because they predated stricter requirements.
But while the FDA program, called the Unapproved Drugs Initiative, succeeded in ensuring many older medicines are now safe and effective, it has come at a cost. Some companies decided to stop selling their drugs, leaving others with a monopoly that allowed them to charge sky-high prices. And a new analysis claims four such examples may be adding a combined $20.3 billion to U.S. health care spending.