The bill, called the “PATIENTS’ FDA Act (pdf),” is designed to complement the proposed agreements negotiated between the FDA and the drug and device industries and calls for transparency in the review and decision progress against the initiatives and metrics agreed to in these prescription drug, generic drug, biosimilar and medical device user fee agreements.
The bill is divided into the following six sections (titles):
- 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
- Strengthening management to support the FDA’s public health mission
“Last month, GAO gave us a report confirming what we already suspected: 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,” said Sen. Coburn, in the release. “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.”
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