Sign-On to Ask Senator Warren to Include OPEN in the Upcoming Senate Bill on Innovation

The EveryLife Foundation for Rare Diseases has asked that advocacy organizations sign-on to this letter urging Senator Elizabeth Warren (D-MA) to support the OPEN ACT (Orphan Product Extensions Now, Accelerating Cures & Treatments).  A link to the letter can be found below, and the letter’s text can be read after the break.

MA Sign-On Letter to Senator Warren: Support the OPEN ACT!


Dear Senator Warren:

On behalf of the rare disease patients and their families living in Massachusetts, the undersigned organizations are writing to request your support for bipartisan legislation that would significantly increase the number of treatments for rare diseases. With 95 percent of rare diseases having no FDA-approved treatment, it is critical that Congress enact policies that will bring aid to the nearly 30 million Americans suffering from a rare disease or condition.

We urge you to support the inclusion of S. 1421, the Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN ACT), in the Senate’s medical research and innovation legislation being considered this fall.  This bipartisan bill sponsored by Senators Amy Klobuchar (D-MN) and Orrin Hatch (R-UT) would lead to the development of hundreds of safe, effective, and affordable rare disease treatments within the next several years by incentivizing drug makers and innovators to “repurpose” already approved drugs for life-threatening rare diseases and pediatric cancers. In exchange for investing the resources to achieve an FDA-approved rare disease indication on the medicine’s label, the OPEN ACT would grant six months of market exclusivity to repurposed drug.

Requiring drug makers and innovators to obtain FDA-approval for the rare disease treatment means that patients can have confidence that the medicines they are taking are thoroughly tested for safety and effectiveness, and that researchers have studied and determine dosage levels. This would decrease unmonitored off-label use and would clear the way for insurance coverage.

As the Senate Health, Education, Labor and Pensions Committee, as well as the full Senate, considers medical research legislation this fall, we would ask that you join the more than 150 rare disease organizations across the country in supporting the inclusion of the OPEN ACT, S. 1421 in this legislative package.