The U.S. House Energy and Commerce Committee recently advanced a bill that would close a loophole in the Orphan Drug Act.
The Orphan Drug Act of 1983 provides incentives for prescription drug manufacturers to develop treatments for rare diseases. Under the act, therapies that receive the orphan drug designation, have an exclusive seven-year marketing right.
A loophole in the bill allows manufacturers to obtain seven-year market exclusivity by “piggybacking” on the orphan drug status of an older drug. As a consequence, new therapies are blocked from coming to the market.
The Fairness in Orphan Drug Exclusivity Act would close the loophole by requiring all drugs to obtain seven years of market exclusivity under the second criterion of the orphan designation.
The criteria for the orphan designation are that drug is for a disease or condition that affects fewer than 200,000 people in the United States, or is for diseases or conditions affecting 200,000 or more people where there is no reasonable expectation that costs of research and development will be recovered through sales.
The bill was introduced by Reps. Madeleine Dean (D-PA), Earl L. “Buddy” Carter (R-GA), David McKinley (R-WV) and Marc Veasey (D-TX).
The bill now moves to the full House for consideration.