Fairness in Orphan Drug Exclusivity Act

Floor Speech

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Ms. DEAN. Madam Speaker, I thank Representative Guthrie and Chairman Pallone for their support of this critical legislation.

Madam Speaker, I rise in support of H.R. 1629, the Fairness in Orphan Drug Exclusivity Act.

This crucial legislation would close a loophole in the current law that can be 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 a condition that affects fewer than 200,000 people in the United States, or is a drug intended for diseases that there is no reasonable expectation to recoup research and development costs.

This legislation focuses on the drugs 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 their research and development costs and efforts.

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 happened when a manufacturer of a buprenorphine product updated an older product that received orphan drug status and subsequently was given a renewed orphan drug exclusivity. Buprenorphine is used as a treatment for opioid use disorder to help those recovering from addiction. Unfortunately, at the time, the opioid epidemic was raging. It was, by no means, a rare disease, and the drug was not a market loser.

Closing this loophole will ensure that products do not receive an unfair market advantage and, therefore, remains consistent with the spirit and intent of the Orphan Drug Act. We must work to ensure people can gain access to newer therapies and medically assisted treatments that are potentially blocked due to orphan designation.

Madam Speaker, I thank Representative Marc Veasey for introducing this legislation along with me. I thank my colleagues in the House for passing this bill without objection on a voice vote just 6 months ago in the 116th Congress.

Again, I thank Chairman Pallone for bringing this bill forward and for his leadership on substance use disorder and behavioral health issues more broadly.

Madam Speaker, I urge Members to support this bill.

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