Shifting Trends In Marketing Approvals Of Orphan Drugs
Law360 (June 3, 2021, 6:26 PM EDT) -- After stalling the week prior, the U.S. House of Representatives passed the Fairness in Orphan Drug Exclusivity Act on May 19 with an overwhelming majority.
The legislation would amend the Orphan Drug Act by "requiring all drugs that secure seven years of market exclusivity to provide proof that they don't expect to recoup the costs of research and development through sales of a drug."
According to Rep. Madeleine Dean, D-Pa., the bill's primary author, the legislation would close a loophole and "eliminate barriers for innovative medication assisted treatments (MAT) to come to market, boost competition in the marketplace, and drive down...
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