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, President Donald Trump took office and wasted no time signing a slew of executive orders that significantly affect the US Food and Drug Administration (FDA). He also appointed personnel appointments and took broad steps to increase political control over federal agencies.

Soon after taking the oath of office as the 47th president, Trump issued scores of executive orders and directives from the White House, including some that affect how US health agencies communicate with the public, hire staff, and address public health issues. While the orders are not surprising, they signal how the president plans to run US health agencies; how he views diversity, equity, and inclusion (DEI); and how he intends to deal with federal officials that he thinks are not executing his policies.

President Trump also designated acting leaders at several departments and agencies, including naming Dorothy Fink, an endocrinologist, as acting secretary of Health and Human Services (HHS) while Robert F. Kennedy Jr., Trump’s nominee, is vetted by the Senate. Fink served as assistant secretary for women’s health during Trump’s first presidency and is currently HHS deputy assistant secretary for women’s health and director of the Office of Women’s Health.

Politico reported that Sara Brenner, chief medical officer for in vitro diagnostics and associate director for medical affairs at the Center for Devices and Radiological Health (CDRH), has been promoted to FDA principal deputy commissioner and named acting commissioner, while Martin Makary, a John’s Hopkins surgeon, goes through the Senate confirmation process for the commissioner role. Brenner served as senior policy advisor for health and biomedical innovation in Trump’s White House Office of Science and Technology Policy in 2018 and 2019, before becoming diagnostics data lead at the HHS National COVID-19 Response Data Strategy and Execution Workgroup.

FDA updated several other key positions on its leadership page, including Ritu Nalubola as acting deputy commissioner for policy, legislation, and international affairs; Angelique Herbert as FDA acting chief operating officer; and Heidi Rebello as acting associate commissioner for external affairs.

National Treasury Employees Union (NTEU) filed a lawsuit against Trump’s executive order to reclassify certain federal career civil service employees as “Schedule Policy/Career,” known as “Schedule F” employees during his last presidency. The move would give the president more authority to fire such civil servants. The union, which represents HHS employees, said, “reclassifying large numbers of employees … with the intent of making them at-will employees is contrary to Congress’s intent in establishing broad protections for most federal employees.”

Although Trump issued a freeze on implementing new regulations and on external communications, FDA published a final guidance on bioanalytical method validation for biomarkers. The agency said the guidance is intended to help sponsors of investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), on how to validate bioanalytical methods used to evaluate biomarker concentrations.

Sen. Bill Cassidy, R-LA, chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, opened the first meeting of the committee of the 119 Congress on 21 January by stating that despite their differences, Democrats and Republicans on the committee agree on the need to address the high cost of prescription drugs.

Biocentury reported that Patrizia Cavazzoni, former Center for Drug Evaluation and Research (CDER) director, wants a new approval pathway for drugs that treat ultrarare diseases. She argued that the agency’s regulatory flexibility isn’t enough to spur development of ultrarare disease drugs and current regulations and the laws have not been able to keep up with scientific advancements.

Friends of Cancer Research (FOCR) announced that former CDER Director Janet Woodcock has joined its board. Woodcock worked at FDA for almost four decades and served as the head of the agency’s drug center for more than two of those. She also served as the principal deputy commissioner at the agency before her departure in early 2024.

Drugs & biologics

FDA added a boxed warning for Teva Pharmaceuticals’ and Sandoz’s multiple sclerosis drugs Copaxone (glatiramer acetate injection) and Glatopa (glatiramer acetate injection) for the potential to cause anaphylaxis shock, which the agency characterized as “a rare but serious allergic reaction.” While most patients at risk for an allergic reaction to the drug may show symptoms within an hour of taking it, the agency said others may show symptoms years after starting the medication.

Johnson & Johnson announced that its anti-depression nasal spray Spravato (esketamine) had been approved as the first and only monotherapy to treat adults with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. The company said a third of adults treated for depression have treatment-resistant depression (TRD) and do not respond to oral antidepressants alone.

Medtech

Several FDA officials, including CDRH Director Michele Tarver, published a study in the journal Plastic and Reconstructive Surgery on understanding patient preference for smooth versus textured breast implants. Textured implants have a greater risk of causing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) but a lower risk for capsular contracture (CC). The study found that patients were generally willing to accept the higher risk of BIA-ALCL associated with textured implants to potentially benefit from reduced risk of CC and having a more teardrop-shaped implant.

Roche announced that it has received FDA 510(k) clearance with a Clinical Laboratory Improvement Amendments (CLIA) waiver for its cobas liat molecular tests intended to diagnose sexually transmitted infections at the point of care. The tests allow clinicians to diagnose diseases such as chlamydia and gonorrhea (CT/NG) and chlamydia and gonorrhea and Mycoplasma genitalium (CT/NG/MG) using a single sample.

https://www.raps.org/news-and-articles/news-articles/2025/1/this-week-trump-signs-slew-of-eo,-appoints-new-off