Senate Committee Advances Bills To Speed Medtech Regulation
By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee passed a raft of legislation for accelerating the approval of breakthrough devices, combination products, and medical device software.
The first medtech-related bill to pass, S.1077, or the Advancing Breakthrough Devices for Patients Act of 2015, seeks to expand the Food and Drug Administration's (FDA's) expedited review of breakthrough medical devices by including all classes of devices (beyond the current class III only), implementing quicker compliance time frames, and allowing shorter and smaller clinical trials.
Republicans were pushing for a comprehensive list of breakthrough medical devices to be made eligible for expedited review, but a compromise with dissenting Democrats resulted in a shorter list of devices to be covered, according to the Wall Street Journal.
The bill's co-author, Sen. Orrin Hatch (R-Utah), said that “by streamlining the approval process and improving regulatory certainty, we’re giving more patients a fighting chance to improve their lives,” reports the WSJ.
The Senate HELP committee also approved S. 1767, or the Combination Product Regulatory Fairness Act of 2015, which allows FDA to review past studies about the safety and efficacy of combination products, and to rely on previous pre-market approvals. The bill also gives FDA discretion whether to consider the product as a drug, device, or biologic, based on the product's primary intended purpose.
The legislation “will provide needed clarity to the agency’s process for reviewing combination products – whether device/drug, device/biologic or drug/biologic – ensuring more timely and predictable reviews of these novel products and again improving patient access in the long run,” said JC Scott, senior executive VP, government affairs, for the Advanced Medical Technology Association (AdvaMed).
S.1101, or the Medical Electronic Data Technology Enhancement for Consumers’ Health Act (MEDTECH), also advanced. The bill exempts from FDA regulation certain software used in medical devices, including, but not limited to, software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment, or administrative, operational, or financial records software.
FDA already released guidance documents reflecting its intention to not enforce regulations over health apps and certain technologies that receive, transmit, store, or display data from medical devices, if the agency deems them low-risk to patients' safety.
“AdvaMed commends the Senate HELP Committee for advancing three medical technology-related bills that will help ensure more timely patient access to the latest medical innovations and improve the efficiency of FDA’s device review process,” Scott said. “Taken together, these three bills will help improve patient access to some of the latest medical advancements and foster a more efficient, predictable and transparent review process within FDA, all the while maintaining the agency’s strong standards for safety and effectiveness.”
According to Bloomberg, four other related bills were approved by the committee: S. 1878, the Advancing Hope Act of 2015; S. 2055, the Medical Countermeasure Innovation Act of 2015; S. 2512, the Adding Zika Virus to the FDA Priority Review Voucher Program Act; and S. 1597, the Patient-Focused Impact Assessment Act of 2015.
The legislative package is part of a counterpart, comprehensive medical legislation to the 21st Century Cures Act that the House approved last year. Key aspects of that bill seek to provide additional funding for FDA and the National Institutes of Health (NIH), streamlining clinical trials, and advancing personalized medicine.
While AdvaMed commended senators over their passage of the bills for FDA regulatory reform, patient advocacy group National Center for Health Research expressed disappointment.
“We are concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure they are safe and effective. Whether creating a new breakthrough pathway for devices (which already are approved based on much lower standards than drugs) or deregulating health IT software, for example, patients will be at risk,” the group's president, Diana Zuckerman, wrote in a letter to senators.