Bill Ending Orphan Drug Exclusivity Loophole Clears House

May 21, 2021

The House of Representatives on Wednesday voted 402 to 23 to pass bipartisan legislation that would close an orphan drug exclusivity loophole — just one week after the bill was denied passage by House Republicans.

H.R. 1629, the Fairness in Orphan Drug Exclusivity Act, which amends existing legislation to require drugmakers who receive seven years of market exclusivity for a drug that treats a nonrare disease to provide regular updates to the FDA explaining why they can’t reasonably expect to recoup research and development costs from sales within 12 years of launch.

If companies are unable to provide adequate justification to the agency, H.R. 1629 gives the FDA the power to revoke orphan drug exclusivity for the nonrare disease drugs.

Only 23 Republicans voted against the bill Wednesday, a dramatic change from the 250 to 168 floor vote last week when a two-thirds majority was required, keeping the legislation from advancing to the Senate. House Democrats then brought the legislation to the Rules Committee, amending the bill’s rules so that only a simple majority was needed to pass the bill.

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