“Orphan” drug exclusivity, which is intended to reward drug companies’ investment in the development of certain drugs, might soon be harder to get—and keep.
Over the past several months, Congress introduced two similar bills to amend a “loophole” in the Orphan Drug Act (ODA). On October 17, 2019, a bipartisan group of House members introduced H.R. 4712 (“Fairness in Orphan Drug Exclusivity Act”) (“the House bill”). On February 11, 2020, bipartisan Senators sponsored a companion bill bearing the same title (S. 3271) (“the Senate bill”). Consistent with recent political interest in curbing high drug prices, the proposed legislation is intended to limit the availability of orphan drug exclusivity for certain drugs, with the goal of thereby promoting competition.