Fairness in Orphan Drug Exclusivity Act

Floor Speech

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Ms. DEAN. Mr. Speaker, I rise in support of H.R. 4712, the Fairness in Orphan Drug Exclusivity Act.

This legislation would close a current loophole that is used to block competition in the pharmaceutical marketplace. This could deny innovative treatments for opioid use disorder and limit the types of treatments for those in recovery and what they can access.

The Orphan Drug Act of 1983 has 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.

For the latter criterion, this legislation would require all drug manufacturers who obtain orphan drug status to prove that they have no reasonable expectation that they will recover their R&D costs. Importantly, this legislation is narrowly tailored and would not affect any product that does receive orphan drug status under the first criterion.

The scenario this legislation works to prevent, as the chairman has said, is companies 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. Closing this loophole would ensure that a product does not receive unfair market advantage and, therefore, remains consistent with the spirit and the intent of the Orphan Drug Act.

In addition, H.R. 4712 clears barriers for innovative medication- assisted treatments, or MATs, coming to market that will help treat those with substance use disorder. Substance use disorder is by no means a rare disease and should not be treated as such. Medication- assisted treatments can and do save lives.

According to the National Institute on Drug Abuse, in 2016 more than 2.1 million Americans were living with opioid use disorder, but just over 17 percent of people received specialty treatment. Medication- assisted treatment is one of those personalized options. We must work to ensure more people can gain access to newer therapies and MAT treatments that are currently blocked due to an orphan designation.

Mr. Speaker, I thank the bipartisan group of legislators who introduced this bill with me: Congressmen Buddy Carter, Marc Veasey, and David McKinley, as well as Chairman Pallone and Ranking Member Burgess, for supporting the bill, and passing it unanimously out of the Energy and Commerce Committee.

Mr. Speaker, I urge all Members to support this bill.

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