Opinion: Don’t let the maker of a buprenorphine drug abuse the Orphan Drug Act

The 30 million Americans with rare diseases should feel as encouraged as I am by the ongoing and enthusiastic commitment the Food and Drug Administration has made to advancing the approval of orphan drugs. But a loophole exploited by a pharmaceutical company threatens the integrity of this vital act.

Over the past few years, fully one-third of new drugs approved by the FDA have been for rare diseases. The of orphan indications approved by the FDA jumped from 594 in 2016 to more than 770 in 2018. These approvals reflect not, passed by Congress in 1983 to provide incentives for companies to develop orphan drugs. The act gives companies seven years of exclusivity for drugs given an orphan indication, a 25% tax credit for qualified clinical trials, and the waiver of application fees.