Will Risk/Benefit Assessment Bite the Sequestration Dust?

  • by: |
  • 03/06/2013

FDA plans to implement during FY14-FY15 a new structured benefit-risk assessment framework to review new molecular entity (NME) NDAs and original BLAs, according to a five-year draft plan released by the agency. The new framework was one of FDA's commitments under PDUFA V. FDA said it plans to implement the framework when reviewing efficacy supplements for new/expanded indications by FY16, and for all NDAs by FY17. FDA said it will publish completed frameworks for newly approved products on its website.

PDUFA V is part of the FDA Safety and Innovation Act, which was enacted in June 2012 and took effect with the start of the fiscal year in October. The law's new set of rules on the review of applications to market NMEs provide for a longer, more interactive review process between FDA and sponsors.

The draft plan is worthwhile reading – but will it gather dust during sequestration?

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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