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Bipartisan Senate Bill Aims To Accelerate Orphan-Drug Development

Wednesday, September 23, 2015   (0 Comments)
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The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S. 2030) was introduced in the Senate on Tuesday by U.S. Senators Michael Bennet (D-CO), Richard Burr (R-NC), Elizabeth Warren (D-MA), and Orrin Hatch (R-UT). The legislation would affirm the FDA's authority to allow drug and device makers "to use their own data supporting the approval of a targeted therapy to help facilitate additional targeted therapies to treat patients with the same rare disease," according to Senate sponsors. 

The bill is supported by multiple patient/disease advocacy organizations like Parent Project Muscular Dystrophy, the Muscular Dystrophy Association, the Duchenne Alliance and the National Organization for Rare Disorders (NORD). 

The FDA Office of Orphan Products Development (OOPD) currently incentivizes the development of products for rare diseases by offering orphan status to drugs and biologics intended to treat diseases/disorders that affect fewer than 200,000 people in the US. With that comes with seven years of marketing exclusivity during which time the product is shielded from generic competition, as well as tax credits, grants and user fee waivers.

It is unclear how exactly the bill will aid in the development of targeted rare disease treatments. The proposed legislation does not seek to change FDA's current approval standards. Its likelihood of passage may be slim given a lack of specifics on how exactly the bill would help speed the development of rare disease treatments.

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