This Week at FDA: HHS reorg features deep FDA staff cuts; Makary, Bhattacharya confirmed for FDA and NIH

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. The Trump administration announced laying off another 10,000 HHS workers, and Martin Makary and Jay Bhattacharya were confirmed to lead FDA and NIH, respectively.

This week, Robert Kennedy Jr., secretary of the US Department of Health and Human Services (HHS), announced plans to reorganize the department and terminate another 10,000 workers, including 3,500 from the Food and Drug Administration (FDA). He described HHS as a sprawling bureaucracy with tremendous waste and duplication and said job cuts and restructuring would make it more efficient.

While federal labor unions representing HHS workers promised to fight the plan, President Donald Trump signed an executive order ending collective bargaining with federal labor unions on national security grounds under the Civil Service Reform Act of 1978. HHS would be one of the agencies affected by the order.

After the executive order was signed, the Office of Personnel Management (OPM) issued a memo stating that the Federal Service Labor-Management Relations Statute and the Foreign Service Labor-Management Relations Statute (FSLMRS) would no longer apply to certain agencies and agency subdivisions, including HHS. The memo also includes new performance metrics, such as limiting Performance Improvement Plans (PIPs) to 30 days from 120 days and using Chapter 75 of Title 5 of the United States Code to fire workers immediately in certain cases.

The Senate confirmed Martin Makary as the next FDA commissioner and Jay Bhattacharya as the next director of the National Institutes of Health (NIH). Senators voted 56 to 44 and 53 to 47 to confirm Makary and Bhattacharya, respectively.

Barclay Butler was named FDA deputy commissioner for operations and chief operating officer at the Office of Operations. He had previously served as an independent consultant for Barclay Consulting Services and spent more than a decade at the Defense Health Agency.

The House Energy and Commerce (E&C) Committee has scheduled a hearing on 1 April to discuss over-the-counter (OTC) drug regulation. The meeting will allow lawmakers to hear from experts and stakeholders about the Over-The-Counter Monograph Drug User Fee Amendment (OMUFA) program.

FDA updated its Data Standards Catalog, in which the agency renamed and reorganized certain terminologies for clarity, corrected some data standards dates, and more. A key update is that the catalog has renamed the Center for Food Safety and Applied Nutrition (CFSAN) to the Human Foods Program, which was part of a major reorganization last year.

FDA updated its Study Data Technical Conformance Guide, which includes specifications, recommendations, and general considerations for submitting standardized study data using FDA-supported data standards. The updates include updates to four sections of the guide and two new sections.

Drugs & Biologics

The Center for Drug Evaluation and Research’s Accelerating Rare disease Cures (ARC) Program has published two educational videos for stakeholders on using endpoints and natural history study data to develop rare disease drugs. The videos are the first in a series of videos and educational materials that ARC plans to create as part of its Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative to educate stakeholders on rare disease drug development.

FDA has expanded the indication for Novartis' cancer drug Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has been expanded by FDA to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy. Novartis said the expanded indication means patients can now be treated with the drug before receiving chemotherapy, which approximately triples the number of patients eligible for Pluvicto.

Exelixis cancer drug Cabometyx (cabozantinib) was approved by FDA to treat patients 12 years and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). The drug was reviewed under Project Orbis through the Oncology Center of Excellence, which allowed it to be reviewed by the Australian Therapeutic Goods Administration (TGA) and Switzerland’s Swissmedic simultaneously. However, the other two regulators are still evaluating it.

The Center for Research on Complex Generics and FDA have opened registration for a two-day workshop starting 29 April entitled "Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration." The workshop will address using in vitro permeation tests (IVPT) to develop topical drugs.

Sanofi's Qfitlia (fitusiran) has been approved by FDA to treat patients 12 years and older with hemophilia A or B, with or without factor inhibitors. The agency said the approval was a significant step as the drug can be administered less frequently compared to other available treatments.

Medtech

The Center for Devices and Radiological Health (CDRH) published an independent assessment of its Medical Device User Fee Amendment (MDUFA) program, conducted by Eagle Hill Consulting. The report makes three recommendations: implementing a comprehensive framework for workforce metric reporting, centralizing workforce reporting to improve communication, and expanding the current governance framework.

Smiths Medical has issued a class. I recall removing several types of intubation ORAL/NASAL Endotracheal Tubes from the market due to their smaller-than-expected diameters, which may cause underventilation and potential death. The company said that while there have been no deaths so far, there have been eight reported injuries.

Visby Medical’s Visby Medical Women’s Sexual Health Test was granted de novo authorization by FDA as the first at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis that doesn’t require a prescription. It is intended for women with or without symptoms and provides results in about 30 minutes.

FDA published updated information on Bayer's Essure birth control device, which was pulled off the market after a slew of serious adverse events were reported. Even though Bayer removed the products from the US market in 2019, the FDA has continued monitoring and reporting on them from its Manufacturer and User Facility Device Experience (MAUDE) database.

This Week at FDA: HHS reorg features deep FDA staff cuts; Makary, Bhattacharya confirmed for FDA and NIH

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