House advances Fairness in Orphan Drug Exclusivity Act

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The U.S. House of Representatives unanimously advanced the Fairness in Orphan Drug Exclusivity Act on Wednesday.

The bipartisan bill closes a loophole that essentially blocked pharmaceutical competition and prevented new opioid use disorder treatments from coming to market. Introduced by Reps. Madeleine Dean (D-PA), Marc Veasey (D-TX), Earl “Buddy” Carter (R-GA), and David McKinley (R-WV), the bill alters the Orphan Drug Act of 1983, which provided incentives for prescription drug manufacturers to develop products to treat rare diseases by providing the companies with exclusive marketing rights for those therapies that receive an orphan drug indication.

A loophole in the law allows drug manufacturers to obtain this market exclusivity by piggybacking a new drug onto the orphan state of an older drug, essentially blocking new therapies from coming to the market that could aid in the opioid epidemic.

“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,” Dean said. “Thank you to my bipartisan colleagues for supporting this legislation. I am hopeful it will help save some struggling with opioid use disorders.”

The Fairness in Orphan Drug Exclusivity Act would close the loophole by requiring all drugs that obtain market exclusivity under the Orphan Drug Act to show that they have no reasonable expectation of recovering research and development costs through sales in the U.S.

The bill is supported by United, Aimed Alliance, Young People in Recovery, No More ODs – The Savannah Harm Reduction Coalition, A Mother’s Addiction Journey.

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