Senators Introduce Bill To Expedite FDA Approval Of Breakthrough Medical Devices
By Jof Enriquez,
Follow me on Twitter @jofenriq
Three U.S. senators recently introduced a bill that seeks to expedite the development and approval of breakthrough medical devices for patients whose needs are unmet by current FDA-approved devices.
Sens. Richard Burr (R-N.C.), Michael Bennet (D-Colo.), and Orrin Hatch (R-Utah) recently introduced the Advancing Breakthrough Devices for Patients Act (ABDP Act) which is heavily based on breakthrough therapies portion of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), according to an article from the Regulatory Affairs Professional Society (RAPS).
“Building on the success of the Breakthrough Therapy designation for drugs, this legislation applies the similar principles and ‘all hands-on-deck’ approach to devices, while also complementing and enhancing the existing tools, such as priority review, currently in place for devices,” stated an explanation [PDF] published by Burr’s office.
If the legislation is passed, the FDA would have the responsibility to help manufacturers go through an expedited review process for device technologies that “represent breakthrough technologies, for which no approved alternatives exist, offer significant advantages over existing approved or cleared alternatives, or the availability of which is in the best interest of patients,” according to the explanation. The FDA would also help ensure clinical trials are performed as efficiently as possible and would need to issue final guidance documents as expected.
The ADBP Act would require the FDA to grant or deny within 60 days a request for breakthrough designation from a medical device company. Upon granting designation, the agency would assign staff led by a team leader with subject matter expertise for each device under review. The team would review the device sponsor’s manufacturing facility and compliance with the FDA’s Quality System Regulation (QSR) standards. The FDA would also be responsible for permitting, when appropriate, a shift of some data collection requirements from pre-market to post-market.
As RAPS noted, it is unclear how the FDA would apply a “best interest of patients” standard in designating a “breakthrough” device, as this is open to a wide range of interpretations from companies, patients, and legislators with potentially different agendas. Moreover, the ADBP bill — like the FDASIA law before it — does not appropriate funds for resource-intensive breakthrough therapy reviews. This could defeat the purpose of expedited reviews, as lack of funding would slow down the process.
Regardless, industry trade organization AdvaMed threw its support behind the ADBP legislation.
“While FDA has made great strides in recent years to improve the efficiency and predictability of the medical technology review process, more can be done to ensure that the most cutting-edge innovations — those that have the potential to provide the greatest patient benefit — are made available to patients and physicians, something the agency acknowledges as well,” read an AdvaMed statement. “This legislation will help create a more seamless and efficient pathway for breakthrough medical technologies, building on initiatives already underway within FDA and called for under AdvaMed’s Innovation Agenda.”
The FDA recently published final guidance on its device-specific “Expedited Access Pathway” (EAP) program to speed up the approval of safe and effective medical devices that address unmet public health needs. It is based on the FDA’s Center for Devices and Radiological Health (CDRH) Innovation Pathway, piloted in 2011, to facilitate the development and expedite the review of breakthrough technologies.