This Week at FDA: Kennedy faces Senate scrutiny, Trump’s ‘buyout’ offer to federal employees

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, senators questioned Robert Kennedy Jr. about his qualifications to lead HHS, the Trump administration’s “buyout” push has federal workers on edge, and a look at FDA’s sparse communications amid a comms blackout.

Kennedy faced two days of grilling before the Senate Finance and Health, Education, Labor, and Pensions committees concerning his nomination to serve as the next secretary of the Department of Health and Human Services (HHS). The former independent presidential candidate, who has been labeled an anti-vaxxer and conspiracy theorist by some, was criticized by Democrats on both committees while generally being defended by Republican lawmakers.

During the hearings, Sen. Elizabeth Warren (D-MA) noted that Kennedy has made $2.5M from the law firm Wizner Baum for encouraging people to join lawsuits against vaccine makers and that he will earn another 10% if they win. She asked Kennedy to pledge not to receive any compensation from such lawsuits against drugmakers as HHS secretary, and four years after his term, to which Kennedy declined, arguing it would hamper future litigations against drugmakers. However, The Hill reported that after the hearings, Kennedy wrote to Warren and other Senators that he would divest his financial stake in the lawsuit against vaccine-maker Merck regarding their HPV vaccine.

During the hearings, he was also asked about strengthening the US medical supply chain. He responded by saying it was a major priority for President Donald Trump, who asked him to look into the matter and propose ways to bring drug manufacturing from China back to the US. Earlier in the week, Politico reported that the president plans to impose tariffs on Chinese pharmaceuticals.

President Trump issued several executive orders upon taking office, directing federal agencies to stop and rescind any work related to diversity, inclusion, and equity (DEI) initiatives. Following the orders, FDA removed several guidances related to clinical trial diversity and gender. This week, AgencyIQ noted that the FDA’s Oncology Center of Excellence (OCE) had removed two pilot programs from its website, including Project Community and Project ASIATICA, on top of removing Project Equity from its site last week.

One of the president’s executive orders requires federal workers to return to work from the office five days a week. This week, the Office of Personnel Management (OPM) published a memo requiring all agencies to prepare and submit plans for requiring and implementing the president's order to OPM and the Office of Management and Budget (OMB) by the end of business on 7 February.

On 28 January, OPM sent a letter to federal employees detailing the Trump administration's policies for workers, including its return to office policy. The letter also offered employees the opportunity to resign from their positions by 6 February, which will allow them to "retain all pay and benefits regardless of your daily workload and will be exempted from all applicable in-person work requirements until September 30, 2025 (or earlier if you choose to accelerate your resignation for any reason)."

"If you choose to remain in your current position ... At this time, we cannot give you full assurance regarding the certainty of your position or agency but should your position be eliminated you will be treated with dignity and will be afforded the protections in place for such positions," the letter stated.

OPM later published a Frequently Asked Questions page that stated that federal workers would not need to work at their job during the deferred resignation period if they go on administrative leave, encouraged workers to find a job in the private sector, and said they are welcome to use the time until they officially resign to stay at home or go on vacation. The agency also sent a memo to all department heads and acting heads, directing them to reassign or eliminate the positions of employees who agree to resign, and submit weekly reports on how many employees have accepted the deal.

The deferred resignation offers prompted backlash from several federal workers' unions and lawmakers. According to Federal News Network, Doreen Greenwald, president of the National Treasury Employees Union, which represents HHS employees as well, told workers to reject the deal and said it was unreliable and "a hostile effort to disparage federal employees, weaken agencies and disrupt the valuable services that these employees provide." The Alden Law Group, specializing in federal employment law, also advised workers that there's no guarantee that those who accept the deal will be placed on paid administrative leave.

The Washington Post reported that Sen. Tim Kaine (D-VA) argued the president does not have the authority to offer the deferred resignation deal.

There’s no budget line item to pay people who are not showing up for work,” Kaine said on the Senate floor. “If you accept that offer and resign, he’ll stiff you.”

Troy Tazbaz, director for digital health at the Center for Devices and Radiological Health announced on LinkedIn that he is leaving FDA on his second anniversary at the agency. After Bakul Patel left FDA to work for Google, he took on the role and led the agency’s work in developing policies on artificial intelligence-enabled devices.

Drugs & Biologics

It’s been another quiet week for FDA observers amid the Trump administration’s communications pause for US health agencies, which expires on 1 February. However, a couple of agency emails and notices in the Federal Register indicate that the communications freeze may be starting to ease.

In its first press release of the Trump administration, FDA announced on Thursday that it approved Vertex Pharmaceuticals' Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic treatment of moderate to severe acute pain in adults. The drug received the agency's breakthrough therapy, fast track, and priority review designations.

On 3 February, FDA is expected to publish two revised final guidances on reducing the risk of transmission of disease agents associated with sepsis and another on mycobacterium tuberculosis (Mtb) by human cells, tissues, and cellular and tissue-based products (HCT/P). The guidances were supposed to go into effect within four weeks of being finalized, but now they won't go into effect until 4 May to give the Trump administration extra time to review them.

In the ongoing political fight over the abortion drug mifepristone, grand jurors at the District Court for the Parish of West Baton Rouge in Louisiana issued an indictment against Margaret Carpenter, a New York physician, her company Nightingale Medical, and the mother of a minor who was prescribed the abortion pills across state lines. WAFB reported that it appears to be the first instance of criminal charges brought against a physician for prescribing mifepristone.

Novo Nordisk announced that FDA has approved its highly successful diabetes and weight-loss drug Ozempic (semaglutide) to treat adults at risk of worsening kidney disease and cardiovascular death who have type 2 diabetes and chronic kidney disease (CKD). The company noted it is the only GLP-1 receptor agonist drug approved for that purpose.

Axsome Therapeutics announced that FDA had approved its drug Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. The company expects the drug will be available in the US in four months.

Medtech

FDA warned users about cybersecurity vulnerabilities found in Contec CMS8000 patient monitors and Epsimed MN-120 patient monitors, which are relabeled Contec CMS8000 patient monitors. FDA said the vulnerabilities could enable unauthorized users to control the devices remotely, cause them to not function as intended, compromise the devices or networks they are connected to, or compromise sensitive patient information.

Nova Biomedical issued a class I recall for its StatStrip Glucose and Glucose/Ketone Hospital Meters due to a software issue that could potentially cause the incorrect glucose and/or ketone readings from patients to be transmitted to the hospital medical system. The error could lead to faulty treatment decisions that could seriously harm patients. The company has issued a software update to fix the problems.

Mercury Medical has issued a class I recall for its Neo-Tee T-Piece resuscitators due to a problem with a small spring in the controller that may prevent the device from delivering the proper pressure levels needed for effective ventilation. The issue could reduce positive pressure, affecting the patient's breathing support and causing serious adverse events. Users have been told to identify the affected devices and stop using them.

This Week at FDA: Kennedy faces Senate scrutiny, Trump’s ‘buyout’ offer to federal employees

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