Bill to close orphan drug loophole clears House

The House voted unanimously Nov. 18 to pass the Fairness in Orphan Drug Exclusivity Act, according to Rep. Madeleine Dean, D-Pa., a co-sponsor of the bill. 

The act closes what critics have called a "loophole that blocks pharmaceutical competition and prevents innovative treatments for opioid use disorder from coming to the market."

The Orphan Drug Act of 1983 provides incentives for drugmakers to develop drugs to treat rare diseases, including seven years of marketing exclusivity for drugs granted orphan designation. This allows drugmakers to be financially able to develop drugs that treat small populations of people. 

To receive orphan status, a drug must treat a disease that affects less than 200,000 Americans. But the law also provides the same marketing exclusivity for drugs that treat more people than that if drugmakers cannot recoup research and development costs by sales of the drug in the U.S. This is the loophole that critics say has blocked competition and prevented new treatments for opioid use disorder from coming to market. 

The new act requires drugmakers that obtain the seven-year marketing exclusivity for a drug that can treat a disease affecting more than 200,000 Americans  to prove that they have no reasonable expectation of recovering research and development costs through U.S. sales. 

"The Fairness in Orphan Drug Exclusivity Act will create more treatment options for patients and providers, boost competition in the marketplace, and drive down the cost of new medicines. Thank you to my bipartisan colleagues for supporting this legislation. I am hopeful it will help save some struggling with opioid use disorders," Ms. Dean said. The bill was co-sponsored by Reps. Earl Carter, R-Ga., Marc Veasey, D-Texas, and David McKinley, R-W.V.

Read the full news release here.

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