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Pallone and Eshoo on House Passage of the Fairness in Orphan Drug Exclusivity Act

May 19, 2021
Press Release

Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) released the following joint statement today after the House of Representatives passed H.R. 1629, the Fairness in Orphan Drug Exclusivity Act: 

“The bipartisan Fairness in Orphan Drug Exclusivity Act will help address soaring prescription drug costs by closing a loophole that has been used to unfairly block generic drugs from coming to market,” Pallone and Eshoo said. “This important legislation will preserve the intent of the original Orphan Drug Act by encouraging research and discovery of new therapies to treat and cure rare diseases, while also ensuring that brand manufacturers do not use the program to stifle generic competition from coming to market. We commend Congresswoman Dean for her leadership on lowering prescription drug costs and look forward to continuing to work together to get this commonsense bill signed into law.” 

H.R. 1629, the “Fairness in Orphan Drug Exclusivity Act,” was introduced by Rep. Madeleine Dean (D-PA). The bill closes a loophole in the Orphan Drug Act by requiring drug manufacturers seeking orphan drug designations under the rarely used cost recovery pathway to demonstrate that the costs they incur in developing and making those drugs available in the United States for such disease or condition cannot be recovered. The legislation requires the Food and Drug Administration and the manufacturer of such drug to take into account the sales of all of the manufacturer’s drugs developed under the same orphan drug designation in making this determination. This legislation will ensure that the incentives provided under the Orphan Drug Act are only provided to manufacturers that meet the criteria of the program as intended. The bill passed on the House Floor by a vote of 402-23.