House Passes Bill Targeting Orphan Drug Exclusivity

Law360 (November 17, 2020, 10:32 PM EST) -- The U.S. House of Representatives on Tuesday passed a bill that would require drugmakers to prove they don't expect to recoup research and development costs through sales of a new drug if they want market exclusivity under a shield for drugs that treat rare diseases.

In a voice vote, the House passed H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, which was introduced by Reps. Madeleine Dean, D-Pa., Marc Veasey, D-Texas, Earl "Buddy" Carter, R-Ga., and David McKinley, R-W.Va., to rein in manufacturers' abuse of exclusive approvals for these drugs. Exclusivity is the period when drugmakers get a monopoly on selling...

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