Lawmakers Consider Bipartisan Bills on Drug Exclusivity, Safety

A House subcommittee took up four bipartisan drug bills, including one that would close a loophole in the FDA’s orphan drug program.

H.R. 4712 would require drugmakers who gain the designation based on a cost-recovery analysis to demonstrate “the absence of any reasonable expectation” of cost recovery every year during the seven-year exclusivity period. The cost-recovery mechanism has only been used three times since it was passed in 1983.

Members of the Energy and Commerce Committee’s health subcommittee cited the FDA’s revocation of orphan drug status from Indivior’s overdose-treatment Sublocade (buprenorphine) in November 2019. The agency admitted that it made a mistake in granting the designation because it “was unreasonable to conclude that there would be no cost recovery from sales of buprenorphine.”