5 things to know about the FDA's flawed approach to accelerated drug approvals

Kristi Alcayaga's teenage son, Michael, was able to try a cancer drug called clofarabine that got an accelerated approval from the Food and Drug Administration. But the medicine didn't help him. (Jovelle Tamayo for NPR)

A special Food and Drug Administration process to get patients earlier access to new drugs has come under fire.

The accelerated approval process speeds medicines to market based on preliminary study data. But there's a condition: The drugmaker needs to do an additional study after the drug is on the market to prove the drug really works. If the study doesn't pan out, the drug can be pulled off the market.