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Amy Ritter was Scientific Editor, BioPharm International.
Senator Kay R. Hagan (NC) introduced a piece of legislation called the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act.
Senator Kay R. Hagan (NC) introduced a piece of legislation called the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act. The bill is intended to accelerate the approval process for medicines targeted to conditions for which there are no effective treatments. The bill will be referred to the Senate Health, Education, Labor and Pensions (HELP) Committee that oversees healthcare issues.
Specifically, the bill aims to accelerate approval for treatments that target an unmet medical need, that significantly enhance the standard of care, or are highly targeted therapies for distinct subpopulations. Hagan hopes that conditions for which there are currently no or limited therapeutic options will benefit from the same leg-up that was given to HIV/AIDS treatments in the 1990’s.
According to the backgrounder, the bill contains specific recommendations for accelerating approval, including enhancing FDA access to external scientific and medical expertise, and including patient advocates and disease research organizations in Advisory Committee reviews. The bill also calls for establishing several new positions at FDA to ensure that the agency is up to date on the latest scientific and policy issues, including Chief Medical Policy Officers at the major branches of FDA to address emerging medical and scientific policy issues, and a Chief Innovation Director to ensure rapid development, testing, and review of new drugs and devices.
It should be noted that FDA already has mechanisms for speeding up approval of drugs intended for unmet medical needs: fast track approval, accelerated approval, and priority review. The TREAT Act does not authorize any new funding for FDA, but proposes to reorganize FDA’s internal processes to ensure more consistency and clarity. While many sponsors complain that FDA is lacking in consistency and clarity, I’m curious to see how adding extra director-level positions will improve either.