Bill Would Speed Access to Treatments for Life-Threatening Illnesses

Posted 16 February 2012 | By Alexander Gaffney, RAC 

Senator Kay Hagan (R-NC) introduced a bill in the Senate on 15 February that would accelerate the review and approval of treatments for rare, neglected or serious diseases.

Hagan's bill, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, would also make a number of changes at the US Food and Drug Administration (FDA), including :

  • 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

Hagan noted that the bill intends to transform "FDA's internal processes to ensure more consistency and clarity," but does not contain any government funding to accomplish these tasks.

"This legislation creates a consistent process and a clear and effective pathway at FDA that will encourage the development of innovative treatments for patients otherwise dependent on the uncertainty of medical breakthroughs," said Hagan in a press release.

The bill already has the support of the Biotechnology Industry Association (BIO), the National Organization for Rare Disorders (NORD), Friends of Cancer Research (FOCR).

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