Political Quotes

“Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I too rise in support of H.R. 4712. This is the Fairness in Orphan Drug Exclusivity Act as you have heard. I want to thank Representatives Carter, McKinley, Dean, and Veasey for their work and leadership on this important legislation. The Orphan Drug Act was enacted to incentivize the development of drugs for rare diseases by providing products that receive an orphan drug designation 7 years of market exclusivity. That means a drug produced by another manufacturer that contains the same active ingredient to treat the same condition is barred from entering the market during this time period. One way a drug can receive an orphan designation and subsequent marketing exclusivity is by the manufacturer's demonstration that there is no reasonable expectation that the cost of developing the drug will be recovered. However, we have seen in recent years that some drug manufacturers, in an effort to block competitors from entering the market, have taken advantage of a loophole in this law. Existing law allows an orphan drug designation and marketing exclusivity to carry forward to future versions of the same drug without requiring the manufacturer to demonstrate the drug has not been, and remains unlikely to be, profitable. This legislation closes that loophole.…”