Political Quotes

“I thank Ranking Member Rodgers and Chairman Pallone for their leadership on this bill. I, once again, rise in support of H.R. 1629, the Fairness in Orphan Drug Exclusivity Act. This crucial legislation would close a current loophole that is used to block competition in the pharmaceutical marketplace. The Orphan Drug Act of 1983 provided incentives for prescription drug manufacturers to develop products to treat rare diseases. This includes an exclusive 7-year marketing right for therapies that receive an orphan drug designation. For a drug to qualify, it must either be a treatment for a disease or condition that affects fewer than 200,000 people in the United States or a drug intended for diseases that there is no reasonable expectation to recoup research and development costs. It would require all drug manufacturers who obtain orphan drug status to prove that they have no reasonable expectation that they will recover R&D costs. This legislation works to prevent companies from continuing to use orphan drug exclusivity status for a newly approved drug with an identical ingredient to the former version without having to prove the inability to recoup costs. This exact circumstance, as the chairman described, happened when a manufacturer of a buprenorphine product tweaked an older product that had received orphan drug status and subsequently was given a renewed orphan drug exclusivity.…”