Legislation to Make FDA's Regulatory Calculus More Transparent Introduced in Congress

Posted 19 April 2012 | By Alexander Gaffney, RAC 

Sens. Richard Burr (R-NC) and Tom Coburn (R-OK) introduced legislation that would reform the US Food and Drug Administration's (FDA) regulatory transparency by mandating the agency submit to Congress the scientific and regulatory calculus behind pharmaceutical and medical device submission decisions.

Sens. Burr and Coburn said their bill, the Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS' FDA) Act, is "designed to complement the proposed agreements negotiated between the FDA and the drug and device industries by ensuring appropriate transparency and accountability in the FDA's review and decision processes."

"America's patients want access to the latest, most effective life-saving treatments," said Burr in a statement. "This bill will ensure that Congress and the American people hold the FDA accountable for meeting its performance goals so that cutting-edge medical therapies approved by the FDA reach patients as quickly as possible."

The legislation is also aiming to "better ensure patients have the opportunity themselves to weigh possible risks against the probable benefit of a particular drug or device," reports BioCentury.

"The proposed legislation would also require FDA to work with other regulatory agencies to encourage uniform, scientifically-driven clinical trial standards to optimize global trials, and would grant the agency the discretion to exempt devices already approved in certain Western countries from duplicative clinical testing in the U.S.," explained BioCentury. "The bill would also remove limits on issuance of conflict-of-interest waivers for FDA advisory committee participation that were put in place as part of the FDA Amendments Act in 2007, and would require the agency to issue guidance to standardize the advisory committee process."

Read more:

Senators Coburn and Burr Introduce PATIENTS' FDA Act

Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS' FDA) Act

BioCentury - Senators introduce bill to complement PDUFA reauthorization

Bill Summary - PATIENTS FDA Act

Forbes - Sens. Richard Burr and Tom Coburn Introduce a New Plan to Reform the FDA

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