Pallone and Eshoo on House Passage on Fairness in Orphan Drug Exclusivity Act
Energy and Trade Committee Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairman Anna G. Eshoo (D-CA) today released the following joint statement after that the House of Representatives passed HR 1629, the Orphan Drug Exclusivity Act:
“The bipartisan Fairness in Exclusivity of Orphan Drugs Act will help tackle soaring prescription drug costs by closing a loophole that has been used to unfairly prevent generic drugs from coming to market.” Pallone and Eshoo replied. “This important legislation will preserve the intent of the original Orphan Medicines Act by encouraging research and discovery of new therapies to treat and cure rare diseases, while ensuring that brand-name makers do not use the program to stifle generic competition in the market. We applaud Congresswoman Dean for her leadership in reducing prescription drug costs, and we look forward to continuing to work together to push through this common sense bill. ”
HR 1629, The “Fairness in Exclusivity of Orphan Drugs Act”, was introduced by Representative Madeleine Dean (D-PA). The bill fills a loophole in the Orphan Drug Act by requiring drug manufacturers who seek orphan drug designations under the rarely used route of cost recovery to demonstrate that the costs they incur for developing and making these drugs available in the United States for such a disease or condition cannot be restored. Legislation requires the Food and Drug Administration and the manufacturer of this drug to take into account the sales of all of the manufacturer’s drugs developed under the same orphan drug designation when making this decision. This legislation will ensure that the incentives under the Orphan Medicines Act are only provided to manufacturers who meet the program criteria as intended. The bill was passed on the House floor by a vote of 402-23.