Manatt Health Partner Rachel Sher was quoted in MedTech Dive on Congress’ reauthorization of the Food and Drug Administration’s (FDA) user fee programs, which provide funding for reviewing devices, pharmaceuticals and other medical products over the next five years.
The article explained that Congress is working to pass the package of legislation as the deadline for the bill approaches. Sher discussed how the FDA may be affected if Congress is late, as it relies on user fees to fund the review and approval of medical devices. “Without the ability to collect and spend user fees, the review time for medical product applications will increase,” Sher said. She also addressed how missing the deadline may affect the FDA’s ability to hire new staff, but noted that Congress has not missed it since 1997. “Leaders of the committees of jurisdiction have reiterated their commitment to timely reauthorization,” Sher commented. “These are experienced legislators who understand the serious consequences, for patients and the industry alike, if they do not act before the expiration of the law.”
Read the full article here.