Politicians react to HHS and FDA firings during OMUFA and cybersecurity hearings

Two House Energy and Commerce committee hearings on Tuesday – one focused on the reauthorization of the Over-the-Counter Monograph Drug User Fee Act (OMUFA) and the other on cybersecurity vulnerabilities in legacy medical devices – were sidetracked by reactions to the mass firing of staff at the US Food and Drug Administration (FDA) and other federal health agencies that unfolded as the hearings took place.

At both hearings, legislators and some witnesses expressed strong condemnation of the layoffs, which were announced by Department of Health and Human Services (HHS) Secretary Robert Kennedy last week and are expected to affect some 10,000 staff across HHS, including 3,500 at FDA.

During the Health Subcommittee’s hearing on OMUFA reauthorization, which is set to expire on 30 September, much of the on-topic discussion was directed toward FDA’s regulation of sunscreen.

Witnesses, addressing the topic at hand, expressed concern that other countries, like Australia, use newer chemical filters that offer better protection than the sunscreen products available in the US. The FDA's ability to approve new sunscreen ingredients is limited by the federal Food, Drug, and Cosmetic Act, which categorizes these products as drugs. This classification necessitates animal testing, unlike cosmetics, which do not have the same testing requirement.

Rep. Morgan Griffith (R-VA) lamented that “we are 20 to 30 years behind the Australians on sunscreens.”

Democrats on the committee quickly pivoted to criticism of the Trump administration's cuts to HHS and FDA, as staff across HHS were notified by email, or in some cases upon arrival at their duty station, that their positions had been eliminated. They also expressed surprise that the hearing was taking place on the same day as the layoffs and raised concerns about the resignation of the agency’s top biologics regulator, Peter Marks, who was asked to resign last week.

“Frankly, I can’t believe we are all sitting in this room and having a routine hearing today like nothing’s going on when I woke up to the headlines this morning,” said Health Committee Ranking Member Diana DeGette (D-CO). “There is only one entity that can fix FDA, and that is Congress … FDA is being dismantled before our very eyes, and we are sitting here talking about sunscreens.”

DeGette also lamented Marks’ resignation. “We all worked closely I think everyone in this room has been impressed with his rigor and his fairness,” she said.

She asked Scott Faber, senior vice president of government affairs at Environmental Working Group, to comment on the impact of the firings on the review of OTC drugs.

Faber testified that “cutting 3500 people … makes no sense.” He added that “having worked on [the Food Safety Modernization Act] FSMA with many of you, I know that more people will be affected by foodborne illness … We will all be less safe because of the actions taken this morning.”

Rep. Frank Pallone (D- NJ), ranking member of the full committee, said that “the Trump administration is aiming to hollow out the agency to find tax savings and giant tax breaks for their millionaire friends and they want to get rid of those who will not bend to their anti-science initiatives and medical quackery.”

“These forced layoffs will result in dangerous products slipping through the cracks, while promising new treatments will face delays in getting to Americans,” Pallone added.

Rep. Kim Schrier (D-WA) said that “there is no way cutting 20 percent of the workforce will not affect reviews,” she said and added that some staff “were barred even from getting into the building.”

“Is this really happening in the United States of America? Are we replacing scientists with quacks and are treating measles with Vitamin A?” said Rep Lizzie Fletcher (D-TX). “Does it really matter if we authorize OMUFA” if much of the FDA staff is removed, she added.

The only Republican to comment on the cuts during the hearing was Rep. Brett Guthrie (R-KY). He said “we have to have the proper oversight” of FDA but that “we knew that we had to make things run more efficiently.” He added that “we are going to make sure this is done in the correct way.”

In response, Pallone stated, "I understand that you discuss the agency becoming more efficient. However, the issue I see is that these cuts are indiscriminate." He added, "We need to hold a hearing where you can bring Kennedy in and ask, 'Why are you doing this? It is your obligation to hold a hearing and provide these answers.'"

During an overlapping hearing on cybersecurity vulnerabilities in legacy medical devices held by the House Energy and Commerce Oversight and Investigations Subcommittee, the Republican majority largely stuck to the script and avoided mention of the cuts at HHS and FDA, while Democrats on the committee used the hearing as an opportunity to denounce the mass firings and dismantling of the federal health workforce.

In her opening statement, Subcommittee Ranking Member Yvette Clarke (D-NY) asked how the committee can focus on a specific topic amid the mass layoffs across federal health agencies.

“I have difficulty seeing how we can have a hearing about how the FDA should approach legacy medical device cybersecurity, without first addressing the fact that the Trump Administration and DOGE are dismantling the very agency responsible for medical device safety,” Clarke said, pointing out that the committee doesn’t know how many FDA staff tasked with overseeing cybersecurity issues are being fired.

Pallone also questioned the appropriateness of the hearing amid the layoffs and restructuring across HHS. “The topic of this hearing, while important during normal times, is deeply divorced from the reality that we’re in. The Trump Administration has launched an unprecedented attack on the federal health workforce. The committee Republicans are ignoring that fact and instead examining the narrow issue of cybersecurity in legacy medical devices,” he said.

“At this very moment, there are civil servants at HHS buildings who have shown up to do their important work but are being told that their position has been terminated – and I think they deserve much better than how they’re being treated now,” Pallone added. “You can’t cut 3,500 employees from FDA and say to the American people that there will be no effect on their health and safety."

“FDA cannot address cybersecurity vulnerabilities of legacy medical devices if cybersecurity experts at FDA are fired, and we still don’t have firm details on the results of first round of DOGE layoffs at HHS,” Pallone said. He added that Democrats on the committee have asked HHS for specifics on the previous round of layoffs but have not been given a response.

Later in the hearing, Clarke asked whether the staff reductions at FDA will impact the review, approval, and oversight of medical devices.

“I think any reduction would have a tremendous negative impact on the cybersecurity of medical devices,” said Kevin Fu, Northeastern University professor and former acting director of medical device cybersecurity at the Center for Devices and Radiological Health (CDRH). Even losing just a few cybersecurity experts at the agency would make it “very difficult to address the next Contec kind of vulnerability or the next ransomware outage that affects, at nation-scale, hospitals across the country,” he added.

“Yes, it will have an impact,” said, Erik Decker, vice president and chief information security officer at Intermountain Healthcare, noting that hospitals, manufacturers, and FDA need to work together to manage cybersecurity throughout the product lifecycle.

Midway through the hearing, Subcommittee Chairman Gary Palmer (R-AL) attempted to address the confusion surrounding the layoffs. “We recognize there’s some confusion around the modernization effort for the American people, and we’ve already requested a briefing from HHS so we can have a better of the potential impact to our constituents.”

However, Rep. Lori Trahan (D-MA) followed up by asking Palmer whether the briefing will be bipartisan. Palmer declined to answer and said he’d let her know at a later time.

Politicians react to HHS and FDA firings during OMUFA and cybersecurity hearings

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