ARTICLE SUMMARY:
A new voluntary program for early, intensive collaboration between FDA and companies developing devices.
FDA is proposing a new voluntary program for early, intensive collaboration for companies developing devices in its ongoing MDUFA V negotiations with industry groups. CDRH Director Jeff Shuren unveiled the plan, called the TPLC Advisory Program (TAP), during a May 19 panel session at the Food and Drug Law Institute Annual Meeting. Loosely, the TAP program would combine elements of FDA’s existing Pre-Sub, Breakthrough Device, Early Payor Feedback/Parallel Review programs, and the real-time engagement performed for COVID-19 products, but for the broader sweep of devices going through the agency. While MDUFA user-fee funding historically has focused almost exclusively on funding premarket review activities, FDA wants to expand its frame to fund early engagement about long-term development issues, as well as reimbursement and market adoption considerations, which have become bigger pain points for industry while the review process has become more predictable, Shuren said. “As we look at MDUFA V, we think there is a way we can truly transform the ecosystem and deal with a number of these pain points to get safe and effective technologies to patients,” he noted.
The program would establish a new team of TAP Advisors trained to provide more “dynamic, strategic advice” tailored to each company. It would also expand expertise and capacity of the core review staff to engage in early, rapid, frequent dialogue well before a premarket submission is made, and bring in payor, provider, and patient groups as needed. FDA confirmed the proposal is dependent on industry agreeing to provide the necessary user fees to fund it. So far, companies have pushed for a more austere approach to the MDUFA V funding agreement. (See “Negotiation Time: Industry Plans Hard Line in Imminent MDUFA V Talks,” Market Pathways, January 20, 2021.)
Excerpted from “Pathways’ Picks May 19: MDR in a Week, FDA on TAP, and More to Watch,” Market Pathways, May 19, 2021.
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