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Posted 10 May 2012 | By Alexander Gaffney, RAC
A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA).
The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies, would amend the FD&C Act to include provisions to allow a sponsor to request the breakthrough therapy designation for a drug after the sponsor submits an investigational new drug application (INDA) for that product.
A sponsor's request would be accepted if the drug, either by itself or in combination with other medicines, is intended "to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints."
FDA would then have 60 days to make a decision regarding the sponsor's request. Upon designating a product as a breakthrough therapy, the agency could then expedite the review process in several ways including holding additional meetings with the sponsor, provide advice and communications to the sponsor, provide a cross-disciplinary review team for the product and take steps to ensure the product's clinical trial design is "as efficient as practicable."
The bill is co-sponsored by Reps. Brian Bilbray (R-CA) and Diana DeGette (D-CO) and has been referred to the House Committee on Energy and Commerce for review and markup.
Tags: Designation, 351(a)(1), 505(i), INDA, Breakthrough Therapies, DeGette, Bilbray, House, application, Latest News, Bill, Congress, pharmaceutical, drug, FD&C Act