On the recordNovember 17, 2020
I thank the gentleman for yielding. Mr. Speaker, I am grateful for the time today to let me speak on this important legislation, and I thank Congresswoman Dean for introducing it. I am glad to be a lead Republican on this bill, as it corrects a loophole in the Orphan Drug Act that has been and very well could be taken advantage of at the expense of the American people's health. As you know, Mr. Speaker, the Orphan Drug Act provides incentives for drug manufacturers to invest in research to bring innovative drugs to market that may not become profitable or that treat a small portion of the population. Unfortunately, a loophole exists that allows some drugs to obtain market exclusivity even though they can easily recoup their R&D costs and turn a profit. This exact problem took place in just the past few years when a drug treating opioid abuse disorders got FDA approval-- orphan status--and a new 7-year exclusivity period, despite the active ingredient remaining the same, all based on the drug's original 1994 orphan designation. This subsequently blocked a new, innovative opioid abuse drug from coming to market during the opioid epidemic--a drug that would help save lives. The Orphan Drug Fairness Act would stop some drugs from obtaining exclusivity, in turn allowing more competition and innovation in the marketplace, benefiting consumers' health and lowering costs. Mr. Speaker, I urge passage of this legislation.
