New Bipartisan Bill to Expand Accelerated Approval Pathway

Posted 05 March 2012 | By Alexander Gaffney, RAC 

[Updated 6 March to Include Link to FAST Act.]

An upcoming piece of legislation advanced by Reps. Cliff Stearns (R-FL) and Edolphus Towns (D-NY) would expand the US Food and Drug Administration's (FDA) use of the accelerated approval pathway, reports BioCentury.

The Faster Access to Specialized Treatments (FAST) Act is reportedly similar to Sen. Kay Hagan's (R-NC) bill, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, which was introduced in February.

Hagan's bill would:

  • Increasing access to conflict of interest waivers
  • Changing the makeup of advisory committees to include patient advocates and disease organizations
  • Mandating that FDA provide explanations to sponsors of rejected applications
  • Amend the FDA mission statement to include verbiage about the agency's role in advancing innovation
  • The creation of a management review board within FDA
  • Establish the FDA office of Chief Innovation Director
  • Establish Chief Medical Policy Officers within the Centers for Drug Evaluation Research (CDER), Biologics Evaluation Research (CBER) and Devices and Radiological Health (CDRH)
  • Establish a Clinical Informatics Coordinator to promote health information technology

Stearns and Towns' bill is likely to be unveiled around the next Prescription Drug User Fee Act hearing before the House Energy and Commerce Committee, which is scheduled for 8 March.

Read more:

BioCentury - Lawmakers plan accelerated approval bill

Regulatory Focus - Bill Would Speed Access to Treatments for Life-Threatening Illnesses

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