Fairness in Orphan Drug Exclusivity Act
Floor Speech
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. It requires manufacturers to demonstrate there is no reasonable expectation that the costs of research and development will be recovered for each successor drug, while still preserving incentives for orphan drug development.
While disagreements do remain, Mr. Speaker, on whether these amendments should apply retroactively, those differences should not prevent us from addressing this important issue today.
So I look forward to continuing negotiations on these differences as we work with the Senate and get a bill down to the President's desk for signature.
BREAK IN TRANSCRIPT
Mr. WALDEN. Mr. Speaker, I do not have any more speakers on my side of the aisle on this matter.
Mr. Speaker, I urge colleagues to approve the bill, and I yield back the balance of my time.
BREAK IN TRANSCRIPT
Source