UPH Government & External Affairs

Week Ending May 21, 2021 — House Passed the Fairness in Orphan Drug Exclusivity Act

by | May 24, 2021

The bill, sponsored by Rep. Madeleine Dean (D-PA), aims to close a longstanding loophole for orphan drugs—a designation given by the U.S. Food and Drug Administration to drugs that are developed to treat rare diseases or for which the manufacturer does not expect to recoup development costs. This designation comes with seven years of market exclusivity for the drug, but scrutiny over drug prices has led lawmakers to examine how manufacturers use the designation. Rep. Dean’s bill would require manufacturers to show that they will not recover costs within the first 12 years the drug is marketed prior to granting the exclusivity. The bill passed the house 402-23. It is unclear whether it will get picked up in the Senate.