Sens. Richard Burr (R-N.C.) and Tom Coburn (R-Okla.) introduced a new bill today aimed at reducing the medical device industry’s regulatory burden.
The duo’s "Patients’ Act" (Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA) would "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," according to a press release.
The bill, intended to complement the Medical Device User Fee & Modernization Act, accomplishes this with 6 main initiatives designed to:
- Increase transparency
- Recalibrate risk-benefit considerations
- Reduce paperwork and review delays
- Beef up the expert review system
- Narrow certain FDA controls on 510(k) and investigational device exemptions
- Strengthen FDA’s management processes
"America’s patients want access to the latest, most effective life-saving treatments," Burr said in prepared remarks. "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."
The senators pointed to a Government Accountability Office report released last month that found that, although the FDA met most of its performance goals, "FDA review time and time to final decision for both types of PMAs generally increased" between 2003 and 2010.
"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," Coburn said in prepared remarks. "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."
Among the bill’s provisions are rules mandating that:
- "FDA will be required to document the scientific and regulatory rationale for any significant drug and device decisions to the sponsor or applicant that submitted the application or report."
- "FDA will be required to work with other specific regulatory authorities of similar standing, medical research companies, and international organizations to foster and encourage uniform, scientifically driven clinical trial standards around the world."
- "FDA will be required to ensure legal review of regulatory letters by the Agency’s Office of Chief Counsel occurs before such letters are distributed publicly."
- "FDA will be prohibited from disapproving clinical research based on a determination that the device will not meet the standards for approval or clearance."
The partnership of Coburn and Burr has tackled MDUFMA before. Last summer the 2 called for the medical device user fee reauthorization measure to act as a catalyst for changes at the FDA.
In a letter addressed to the various councils representing the life sciences industry, Burr and Coburn wrote that "reauthorization of the U.S. Food & Drug Administration user fee agreements provides an important opportunity to address the root causes of the threats to our nation’s leadership in medical innovation.
"As you negotiate the next user fee agreement and prepare to submit the proposal to congress, we wish to underscore the necessity of restoring regulatory certainty and predictability," they wrote.
Burr in particular has been a vocal critic of the FDA, casting a skeptical eye on the federal watchdog agency’s promise to meet performance goals in exchange for a doubling of medical device user fees in the MDUFMA III negotiations at a recent Senate Health, Education, Labor & Pensions committee hearing.