Washington, D.C.—Senator Orrin Hatch, R-Utah, the senior Republican in the United States Senate, introduced the Orphan Product Extensions Now Accelerating Cures and Treatments Act (OPEN ACT) of 2017. The OPEN ACT would build on the success of the Orphan Drug Act to provide incentives to increase market potential for companies that repurpose previously approved drugs for the treatment of rare diseases. Repurposing drugs is typically faster, cheaper, and safer than traditional drug development.

“Since Congressman Henry Waxman and I first championed the Orphan Drug Act in 1983, helping medical innovators treat rare diseases has remained among my top priorities,”Hatch said. “This bill is a natural step in expanding that effort to close the gap for rare diseases that do not have treatments. My proposal builds on past work to ensure that rare disease patients have access to the treatments they need.”

Background

Complex rare diseases with small patient populations have limited market potential, so there are few economic incentives to develop new drugs targeting rare conditions. The Orphan Drug Act was a successful first step towards addressing this issue, and led to numerous new lifesaving technologies. While there are 7,000 rare diseases that impact 30 million Americans, 95 percent of these diseases still have no treatments.

The OPEN ACT, S. 1509, would provide an additional six months of market exclusivity to drugs that are repurposed and approved by the Food and Drug Administration to treat rare diseases. This law would apply to currently approved drugs that are still under patent. The six-month extension would be in addition to other types of exclusivity, such as pediatric or qualified infectious disease product exclusivity.

The OPEN ACT is supported by 224 patient organizations.   back...
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