The FDA has resumed several health and safety activities that had been halted by the partial government shutdown, now in its 24th day.
In a series of tweets on Sunday, FDA Commissioner Scott Gottlieb, M.D. listed the tasks that the agency has added to “excepted, unpaid work.”
“It is not business as usual at FDA. Many key functions aren’t getting done,” Gottlieb tweeted. “But we’re focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission-critical functions.”
The newly excepted tasks exceed what the agency has done in past government shutdowns “because they’re necessary to identify and respond to threats to safety of human life,” Gottlieb tweeted. The current shutdown is the longest in U.S. history and shows no signs of ending. Those activities include:
- Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest-risk products and facilities.
- Surveillance sampling of imported high-risk foods, drugs, and devices, and logistical coordination and laboratory support for allowable inspections and evaluation.
- Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices.
- Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life.
“These actions are being taken in close consultation with, and based on direct feedback from, senior career leadership of FDA, our program officers, and our range of experts,” Gottlieb tweeted. “Our mission is focused squarely on securing consumer safety and protecting Americans during these times.”
Gottlieb also said that the agency will add to this list in the coming days, especially veterinary health activities that directly affect human life and safety.
“The lapse in funding represents one of the most significant operational challenges in FDA’s recent history,” Gottlieb wrote. “But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.”
Activities funded by user fees that the agency has already collected will continue, but FDA will not have the legal authority to accept user fees assessed for fiscal year 2019 until an appropriation or continuing resolution for the agency’s fiscal year is enacted. This means that FDA will not be able to accept any regulatory submissions for FY 2019 that require a fee payment and that are submitted during the lapse period.
Medical device companies pay fees to FDA when they register their businesses and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S., and for certain other types of submissions. These actions fall under the Medical Device User Fee Amendments (MDUFA).
No one from FDA was available for further comment on the agency’s work during the shutdown, but an official from the Alliance for a Stronger FDA said that the agency has constantly been evaluating what it needs to prioritize as the shutdown drags on.
About 50% of device reviews are paid for by user fees, and those are continuing during the shutdown because they’re on a separate funding track from the rest of the FDA, said Steven Grossman, deputy executive director of the alliance, an organization of patient groups, consumer advocates, biomedical research advocates, health professionals and industry representatives. FDA surveillance staff is tracking medtech company recalls and will call agency staffers back to work in the event of a serious recall, Grossman added.
The alliance is also updating an FDA shutdown toolkit on its website because of members’ ongoing concerns.
“I think Dr. Gottlieb and his crew are doing absolutely the best job, and doing this iterative process is the best way to be sure that the American public is safe,” Grossman said.
Shaye Mandle, president and CEO of Minnesota-based trade group Medical Alley, agreed that Gottlieb is doing a good job of keeping the industry up-to-date on how FDA is dealing with the shutdown. The agency’s ability to continue processing medtech applications with previously collected user fees has insulated the industry for now, according to Mandle.
“Nobody is experiencing a specific moment of panic, but I will tell you that there’s broad consensus that this needs to get resolved,” Mandle said. “Even if things return to normal quickly there’s a natural backlog of things and reorganization, et cetera. Time isn’t money in healthcare. Time is life in healthcare.”
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