This Week at FDA: Kennedy says some fired staff will be reinstated, judge rules against FDA’s LDT rule, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, after firing thousands federal health workers on Tuesday, Department of Health and Human Services Secretary Robert Kennedy Jr. admitted that some of the cuts were a mistake, and a district judge vacated FDA’s laboratory-developed test rule.

Thousands of workers across HHS, including some 3,500 at FDA were abruptly fired on Tuesday as part of President Donald Trump’s effort to reduce the size of the federal government. Many agency staff only found out they had been let go after commuting to work and then being told to go home.

The same day as the firings, the Senate Health, Education, Labor, and Pensions (HELP) Committee announced it would hold a hearing on 10 April with Kennedy called to testify about his department's reorganization plans. The hearing announcement noted Kennedy’s commitment during his confirmation hearing to speak to the committee every quarter to answer questions about the workings of HHS.

Just two days after the firings, ABC News and Politico Pro reported that Kennedy told reporters that some 20% of the fired would be reinstated.

"The part of that, DOGE – we talked about this from the beginning – is we're going to do 80% cuts but 20% of those are going to have to be reinstalled because we'll make mistakes," Kennedy said. However, Kennedy did not elaborate on what programs or staff would be restored.

Former FDA Commissioner Scott Gottlieb warned on X that the US market may become less attractive to drug manufacturers and lead to products coming to Europe first as a result of the cuts.

"Through a generation of congressional actions, investments in expertise and hiring, and careful policymaking, we built the FDA into the most efficient, forward-leaning drug regulatory agency in the world—and established the U.S. as the global center of biopharmaceutical innovation," he said. "Today, the cumulative barrage on that drug-discovery enterprise, threatens to swiftly bring back those frustrating delays for American consumers, particularly affecting rare diseases and areas of significant unmet medical need,” Gottlieb wrote.

After being confirmed as FDA commissioner, the Pink Sheet reported Martin Makary was sworn in to the role in private last week. Makary kicked off his tenure as commissioner with an all-hands meeting on Wednesday, just one day after what some have dubbed as FDA’s “Black Tuesday.” He gave a speech in which he emphasized the need to challenge “deeply held assumptions” and use science and common sense to address America’s health care problems. He spent most of his speech talking about how health outcomes in the US have significantly deteriorated over the last generation, and the agency needs to do its part to address them.

Some FDA staff who spoke to Focus and were granted anonymity due to fear of professional reprisal said they did not find Makary’s words comforting or assuring, especially considering the loss of so many colleagues who were crying in the same buildings the previous day. One source described the speech as “bizarre,” while another said it was “tone deaf” as it focused more on Makary’s personal stories and less on what he was bringing to FDA to ensure the agency could accomplish its public health mission.

The House Committee on Oversight and Government Reform will hold a hearing on 9 April to discuss counterfeit products. The committee said experts will testify on steps FDA can take to reduce inefficiencies and bureaucratic hurdles to allow new products on the market while preventing counterfeit ones.

Drugs & Biologics

Following the latest firings across FDA, the Pink Sheet reported that the Center for Drug Evaluation and Research (CDER) has lost more than a thousand workers and has less than 5,000 employees left. According to an HHS memo, FDA may go through further restructuring as the department looks to "remove unnecessary management layers and offices and streamline them into five shared services offices.”

Reuters reported that Aldeyra Therapeutics received a complete response letter for its investigational drug reproxalap to treat dry eye disease. The agency said the company had failed to demonstrate the drug's efficacy and asked it to conduct at least one more clinical trial to prove that it works.

Medtech

Last year, FDA finalized a rule that would increase its regulatory oversight of laboratory-developed tests (LDTs) and phase out its longstanding enforcement discretion policy. The laboratory testing industry, including the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), sued the agency, arguing that it has doesn’t have the authority to regulate the tests. (RELATED: FDA issues long-awaited LDT final rule, Regulatory Focus 29 April 2024)

This week, a district judge in the Eastern District of Texas vacated the rule and said that the FDA’s attempt to regulate laboratory testing services as medical devices exceeded its statutory authority.

“This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country,” said ACLA President Susan Van Meter in a statement after the ruling was handed down.

The court sided with ACLA's arguments that laboratories provided LDTs as a service rather than a product, even if they were leveraging FDA-regulated products and equipment. The court also said that FDA lacks jurisdiction and authority to regulate the products and vacated the current version of the final rule. (RELATED: Trump administration’s defense of LDT rule catches legal expert by surprise, Regulatory Focus, 21 February 2025)

Phillip Desjardins, a partner at Arnold & Porter, told Focus that FDA now has three options moving forward, including appealing the court's findings.

"Right now, I don't believe that is likely," he said. "I think you have a new FDA leadership in which exercising enforcement over LDTs either is not their top priority, it might not be a priority period, and I wouldn't be surprised if they took no further action or appeal on this issue with the courts."

However, Desjardins said there is one caveat: If FDA does an analysis and thinks the court's order could impact its authority in other areas, it may be motivated to appeal the decision. Alternatively, he said FDA may also decide not to appeal the ruling but leave the rule in the books, recognizing that it is not legally binding, and that the laboratory industry will not comply with it. He said it is probably the path of least resistance in the short term.

According to Desjardins, the third option is that FDA withdraws the rule, recognizing the court's decision that it does not have jurisdiction, which addresses the issue in the short and medium term. However, the agency could come back in a few years when there's been a leadership change and try to issue a similar rule to regulate LDTs.

Ultimately, Desjardins said the court's ruling could have broader implications for the FDA's ability to regulate products, especially in areas where the agency has been using its enforcement discretion.

"If I were FDA I would be looking back [and asking] are there other areas today that we're exercising enforcement discretion that we may choose to change our mind in the future," he said.

Desjardins noted that decades ago, FDA determined LDTs posed low risk to patients and decided to use its enforcement discretion. Since then, how LDTs are marketed and what they are used for has changed, leading the agency to determine they now pose a higher risk and should be subject to greater scrutiny.

With that in mind, Desjardins said the agency might decide to examine other products on which it has applied enforcement discretion and whose risk profiles may change over time.

In recent years, bipartisan efforts have been made to pass legislation, including the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which ACLA contributed to writing without supporting. While the bill came very close to passing, its failure ultimately led FDA to issue the LDT rule.

Desjardins said that despite bipartisan support for diagnostic reform, he doubts there will be any legislative proposal, at least in the next year and a half, to address the issue.

"I don't believe there is appetite right now for a legislative solution in the short term... but I do believe that everybody looking at this issue thinks that a legislative solution is the best path forward," said Desjardins. "It provides the lab industry with certainty, and it also allows them to play a role to hopefully work through what would be workable from a patient perspective, from a consumer perspective, that would make sense in the space in hopefully addressing some of the underlying safety concerns that FDA and maybe other public health advocates have identified."

While the ruling is a big win for the laboratory industry, Desjardins said there is still a great deal of uncertainty about what may happen to the industry in the long term. He said legislative solutions could help bring more certainty to the space.

Traditionally, the next round of the Medical Device User Fee Amendments (MDUFA) negotiations should start this summer, and Desjardins said he expects ACLA will be and should be at the table as it has in the past.

"I honestly don't know the process how all this will play out politically in the next round of user fees, but I have not seen anything proposed that would change the dynamics of whose at the negotiation table, who's involved in those conversations, and my premise would be that having both the diagnostic and the laboratory community involved in the conversation is probably for the better," he added.

Medtronic has issued a class I recall for its Aortic Root Cannula, which is used during cardiopulmonary bypass surgery. The company said it removed the products from the market after discovering a risk of unexpected loose material in the male luer used in the cannula, which could potentially become dislodged and cause serious harm to patients, including death.

This Week at FDA: Kennedy says some fired staff will be reinstated, judge rules against FDA’s LDT rule, and more

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