Rep. Veasey (TX-33) Applauds Passage of Fairness in Orphan Drug Exclusivity Act

WASHINGTON, D.C. – Today, Rep. Veasey (TX-33) applauded the passage of the Fairness in Orphan Drug Exclusivity Act (H.R. 1629). The legislation was re-introduced by Reps. Dean (PA-04) and Veasey (TX-33) earlier this year and will expand life-saving opioid treatment options by closing the loophole that could be used to block pharmaceutical competition and prevent innovative treatments for opioid use disorder from coming to market.

"I applaud today's passage of the Fairness in Orphan Drug Exclusivity Act and I am glad that our Democratic Majority pushed ahead with bringing it to the floor again for a vote after last week's partisan attempt to hold this legislation hostage," said Rep. Veasey (TX-33). "Fighting the opioid epidemic cannot wait any longer. In the past 20 years, we have seen a drastic increase in opioid addiction with nearly every state in the nation seeing a spike in overdose deaths. Passing our Fairness in Orphan Drug Exclusivity Act will help curb this senseless loss of life by expanding treatment options and driving down costs of new medicine."

Background

For decades, The Orphan Drug Act of 1983 has provided incentives for prescription drug manufacturers to develop products to treat rare diseases — including an exclusive seven-year marketing right for therapies that receive an orphan drug indication.

For a drug to qualify for orphan designation, certain criteria must be met:

- The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States; or

- For diseases or conditions affecting 200,000 or more people, there is no reasonable expectation that costs of research and development (R&D) of the drug can be recovered through sales.

Because opioid use disorder affects millions of Americans, the first criterion does not apply to new opioid medications.

However, a loophole allows manufacturers to obtain seven-year market exclusivity under the second criterion by "piggybacking" on the orphan drug status of an older drug – even if they expect to easily recoup their R&D costs on the new version.

The Fairness in Orphan Drug Exclusivity Act would close this loophole by making a minor update to the Orphan Drug Act – requiring all drugs that obtain seven years of market exclusivity under the second criterion to show that they have no reasonable expectation of recovering R&D costs through sales in the United States.

You can watch Rep. Veasey's floor speech supporting the legislation here.

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