ARTICLE SUMMARY:
In this week’s roundup: US lawmakers try to avert a shutdown; billion-dollar gap in MDUFA V talks; insights from FDA on biocompatibility, change protocols, eSubmissions; China makes a series of moves to shore up its device clinical trial policies; EU policymakers eye “borderline” products and IVD Regulation stresses; India government considers delaying new regulatory mandates in light of COVID-19; and more.
US lawmakers have until midnight Thursday to ward off a government shutdown amid a continuing pandemic response. Meanwhile, the gap between FDA’s and industry’s positions in ongoing user fee negotiations remains about a billion-dollars wide. That and much more from the US, China, and Europe in this week’s Pathways’ Picks roundup of what you need to know in the global medtech policy sphere.
FDA Picks
Finances, fees, insights, and more:
The shutdown lowdown. Democrats in Congress have announced they reach agreement on a short-term (through December 3) bill to fund the federal government to prevent a shutdown. They hope to pass it on Thursday, hours before the fiscal year ends. A shutdown, now or later in the year, would pile more pressure on an FDA that remains in pandemic-response mode. According to a contingency plan posted in August, FDA would be able to retain 69% of its staff in the event of shutdown by leveraging carryover user fee funds and retaining some staff that is officially considered “vital” for human health. The remaining 31% would be furloughed at a time when the agency has just recently returned most of its review offices (except IVDs) closer to pre-pandemic functioning. Officials have already warned the device center will miss some MDUFA IV performance goals as a result of the compounding COVID-19 pressures. A shutdown that goes on for more than few days will only make the situation worse.
Billion-dollar gap. In the context of these financial pressures, FDA is looking for a big influx in funds in the next device user fee program, well beyond what industry says it can support. According to materials obtained by Market Pathways from a closed-door negotiation meeting last week, FDA is seeking about $2.5 billion in industry fees in the fiscal years 2023-2027 MDUFA V program, more than double what device trade groups have proposed. FDA’s plan would maintain pre-pandemic review performance while launching the TPLC Advisory Program (TAP). Read more in our latest report from the MDUFA V negotiations: “More Than a Billion-Dollar Gap Between FDA and Industry User Fee Positions,” Market Pathways, September 24, 2021.
