The three regulatory bills are expected to be paired with Democratic priorities related to funding the NIH and FDA in a comprehensive package akin to the 21st Century Cures Act, which passed in the House. The two parties were reportedly struggling to come to an agreement, but good old-fashioned compromise helped secure passage of several bills through the Senate’s Health Education, Labor and Pensions (HELP) Committee.
For example, a bill to accelerate approval of breakthrough devices contains a shorter list of eligible devices than the Republicans would have preferred. “I would not have been voting yes had a lot of work not been done,” committee member Sen. Tammy Baldwin (D-WI) told The Wall Street Journal. Questions about the extent of funding for the NIH, and how it would be financed, remain, the WSJ reports. Agreements on NIH and FDA funding will be needed to secure Democratic votes for final passage.
Out of the five (5) bills that made it past the committee, the three bills with direct relevance to med tech are The Advancing Breakthrough Medical Devices for Patients Act of 2015, The Combination Products Innovation Act of 2015 and The Medical Electronic Data Technology Enhancement for Consumers Health Act. The breakthrough medical devices bill builds on the FDA’s Expedited Access Pathway, which was implemented last year, and has a handful of devices in the pipeline.
Most notably the proposed condition for entry into the program appear broader than the current mandate, which restricts eligibility for the EAP to devices that “demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.” The bill would permit devices that have the potential, when compared to approved alternatives, to “reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies.” As is currently the case, only devices for which no approved alternatives exist would be eligible.
In addition, the bill calls on Congress to assign a team of staffers for each device in the pathway and take other steps to speedily review the device, including agreement to a data development plan and efficient clinical trials, both of which are currently called for in the existing pathway’s guidance. Meanwhile, the bill on combination products would tip the scale in favoring of review of drug/device products via the less stringent device pathway. It achieves this aim by ensuring sponsors can meet with the FDA within 30 days if their combination product review plan is rejected by the agency. It also requires the FDA to provide justification if a combination product is not designated as a device, and respond to the sponsor in 90 days regarding additional studies.
In addition, the bill clarifies that the “Secretary shall not determine that the primary mode of action is that of a drug or biological product solely because the combination product has any chemical action within or on the human body.”
The FDA is aware that combination product decisions are some of the most contentious (and litigious). In a recent blog post it told stakeholders to “stay tuned for more information about other key priorities and initiatives (albeit inter-agency ones) aimed at modernizing the review of combination products.”
Finally, the Medical Electronic Data Technology Enhancement for Consumers’ Health Act excludes many types of software from FDA regulation. In fact, the agency has already released guidance saying it will opt not to regulate various software; AdvaMed said the bill will “codify FDA’s current regulatory paradigm for medical technologies that utilize software.”
Overall, the trade association was pleased with the latest development, saying, “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.” However, Diana Zuckerman, President of the National Center for Health Research, wrote in a letter to senators on the HELP Committee, “We are concerned that the focus of these bills is on getting medical products to market more quickly, instead of making sure that they are safe and effective,” according to The Wall Street Journal.
Many at the FDA are concerned a comprehensive package would lead to “unfunded mandates,” highlighting the importance of the agency funding component of a final bill.
The Agency just asked the device to pay an additional $500 million in user fees during negotiations over the reauthorization of the Medical Device User Fee Act.
REFERENCE: Fierce Medical Devices; 10 MAR 2016; Varun Saxena