PATIENTS' FDA Act introduced to make agency more accountable

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U.S. Senators Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) have introduced the Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS’ FDA) Act, a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.

"Meaningful congressional oversight will ensure that the FDA is held accountable for its performance goals and is fulfilling its public health mission on behalf of patients in a predictable and timely manner, including decisions on life-saving drugs and devices," the senators said in a statement. "This will help keep medical innovation and job creation from going overseas, which jeopardizes American patients’ access to the most cutting-edge medical therapies and advances."

“Government red-tape at the FDA is stifling scientific investment and innovation, which is a disservice to North Carolina’s medical innovators and even worse can delay patients’ access to medical therapies. Our bill will help identify areas where the FDA needs to do better,” Burr said.

Burr cited a GAO report that says that the FDA is taking longer and longer to make final decisions on life-saving medical devices and not meeting vital performance standards due to a complete lack of congressional oversight. “When a government agency consistently shows signs of failing to meet its public mission and is failing to help some of the very people it was intended to protect, there is no one else to blame but Washington. Instead of harming life-saving innovation, the PATIENTS’ FDA Act ensures a rigorous, careful, transparent, and accountable system, and more importantly, gives patients the access to care that they deserve,” Coburn says.

The senators said the PATIENTS’ FDA Act will enable Congress to fulfill its duty to the U.S. people by ensuring that the FDA is promoting the public health through its review and regulation of medical products. Because the FDA’s work on behalf of patients is supported not only by user fees, but also by taxpayer dollars, Congress has a critical oversight role in ensuring the FDA is meeting its requirements under the law, they said.

The act includes several objectives including the following:

  • Ensuring greater transparency and accountability in FDA decision-making;
  • Recalibrating risk-benefit considerations;
  • Reducing unnecessary delays and regulatory burdens;
  • Strengthening the advisory committee process for patients;
  • Medical device regulatory improvements; and
  • Strengthening management to support the FDA’s public health mission.

A summary of the act is available here.