With no end to the government shutdown in sight, today AdvaMed announced proposed legislation that aims to help “fix” some of the disruption that FDA is experiencing in collecting user fees and reviewing device applications during this (and future) shutdown(s). Concern has been mounting over the shutdown’s impact on the medical device industry, especially the device user fee program. CDRH is currently using existing user fee carryover balances, and only submissions received before the shutdown started are being reviewed—none of the applications that came in during the past month are being reviewed, said Scott Whitaker, president and CEO of AdvaMed, during a conference call with the media today.
“We don’t know how long the shutdown is going to continue,” said Whitaker, adding that there is concern over the long-term impact this will have on the device approval process, because carryover balances are only expected to last two to three months—with three months being a worst-case scenario. And with an average number of device submissions to FDA reaching as high as 300 per month, a prolonged shutdown means a significant backlog.
As a result, AdvaMed is proposing legislation that would allow FDA to continue collecting user fees and continue to review applications that come in with those user fees during a shutdown. The following proposals draft language was provided to the media:
“(a) Notwithstanding a lapse in appropriations for the Food and Drug Administration, the Secretary shall accept device submissions described in section 738(a)(2) of the Food, Drug, and Cosmetic Act and registrations described in section 738(a)(3) of such Act during such lapse in appropriations if an applicable fee has been submitted for such submission or registration, and such fee shall be considered to have been paid and is hereby appropriated and shall remain available until expended.”
“(b)(1) During any time period in which there is a lapse in government appropriations for the Food and Drug Administration, the Secretary shall apply to the process for the review of device applications any fees paid for device submissions described in section 738(a)(2) of the Food, Drug, and Cosmetic Act and registrations described in section 738(a)(3) of such Act, and either a submission has not been received for such submission fee or a remitter has not been identified for such establishment fee, and such fees are hereby appropriated and shall remain available until expended.
“(2) Notwithstanding the application of a user fee for the process for the review of device applications pursuant to paragraph (1), such fee shall be deemed to have been paid for purposes of section 738(f)(1) of the Food, Drug, and Cosmetic Act if the Secretary subsequently receives a submission or registration for such fee.”
“We’re not assuming that this helps resolve the government shutdown,” said Whitaker, but they are anticipating a “protracted shutdown” and are trying to stay ahead of the game. He said thus far, reaction to the proposal has been positive.