The ongoing partial federal government shutdown has meant staff furloughs and some delayed routine services by the FDA, excluding fee-funded activities. The medtech industry hasn’t been complaining about it yet, but time will tell, according to some experts.
“Agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds,” the federal watchdog said on its website. “… All our work is important, but only some of our work is permitted to continue during a lapse in funding.”
The Medical Alley Association in Minnesota has been asking its members if the shutdown has been affecting their companies, according to Frank Jaskulke, VP of intelligence for the trade group.
“Certainly, none of them are happy about it, but we haven’t had anyone call and tell us it specifically impacts the work they’re doing,” Jaskulke said. “I expect that would change if it keeps dragging on.”
FDA said that critical public health activities that will continue include:
- Emergency response to foodborne illness and the flu.
- Supporting high-risk food and medical product recalls when products endanger consumers and patients.
- Pursuing civil investigations public health appears at imminent risk.
- Pursuing criminal investigations.
- Screening imported food and medical products.
- Addressing other critical public health issues that involve imminent threats to the safety of human life.
“Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue,” the agency said. “FDA would be unable to support some routine regulatory and compliance activities. This includes some medical product, animal drug, and most food-related activities. FDA will also pause routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.”
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).
“You worry about clearances and approvals,” Jaskulke said. “They can’t take new (MDUFA) money.”
Mike Drues, president of the Vascular Sciences regulatory consulting firm, said he hasn’t noticed any slowdown in responses from FDA on the presubmission applications he’s working on for clients.
“Publicly, FDA has said that activities that are user-fee funded are not being affected,” Drues said. “I spend a lot of my time doing presubs. There is no presub user fee, at least not yet, although give Congress a little time. That said, with regard to presubs, I’ve got several pending right now, probably three or four, and we’re still getting responses from FDA reviewers.”
Madris Tomes, a former FDA analyst who is founder and CEO of medical device safety information software company Device Events, worked at FDA during the furlough of 2013. Tomes was unsure whether the agency is following the same protocol for the current shutdown, but described her experience thus:
“The pre-market reviewers continue work on approving/clearing new devices as long as the application was received prior to the shutdown. This is because they are funded by MDUFA (industry fees),” she said. “The post-market surveillance division that reviews adverse event reports (~65K per month) is furloughed unless there is a (Public Health Service) person on staff to read them. This left that division with one reviewer who focused on death reports and code blue (serious injury or death could occur). That’s a huge amount of reading for one person.”
FDA employed 17,397 before the partial shutdown. It listed 9,107 as “authorized by law” to continue working during the shutdown, 1,237 as necessary to the “safety of human life and protection of property,” and thus also allowed to continue working. It wasn’t clear how many of the total 7,053 furloughed FDA employees work in its Center for Devices and Radiological Health, which regulates medical devices. The shutdown is in its 14th day.
FDA Commissioner Scott Gottlieb wrote a general message to agency employees on its website.
“I know this lapse in appropriations funding creates personal uncertainty for many of you, and private hardships,” Gottlieb wrote. “I also know how deeply you care about the FDA’s mission, and the obligations we have to the American people. There are many Americans who live vulnerable lives, for whom the protections of public health that we provide are especially important.
“I hope you know that this current situation in no way reflects any diminished view on the importance of that mission. It’s in times of challenge that the significance of our role is most clear, and when our commitment to carrying on our essential functions is most critical.”