This Week at FDA: HHS staff assessments raise concerns, former FDA chiefs criticize DOGE, 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, there are reports that some staff are concerned that a new HHS performance assessment could be a prelude to more layoffs, former FDA chiefs criticized last year’s mass firings, and more.
STAT News reported that some staff at the US Department of Health and Human Services (HHS) are suspicious of a new requirement in their annual review: submitting a 6,000-word self-assessment by 16 October. Speaking anonymously to the news outlet, federal workers said they worry that the move may be part of the Trump administration's 2025 reduction-in-force (RIF) efforts and/or efforts to make them quit.
STAT News also reported that former FDA Commissioners Robert Califf and Scott Gottlieb criticized the Trump administration's RIF efforts through the Department of Government Efficiency (DOGE) last year during a talk at the 2026 STAT Summit. Califf said it would go down as "one of the biggest disasters in American history," while Gottlieb bemoaned the loss of institutional memory at the agency. Former acting FDA Commissioner Ned Sharpless also criticized the cuts, calling them "arbitrary," and said medical product companies now must deal with more junior, less experienced reviewers.
Semafor reported that White House aide and FDA commissioner-nominee Heidi Overton played a larger role than previously known in pushing to reduce the number of Centers for Disease Control and Prevention (CDC)-recommended vaccines for children from 17 to 11. One former administration official claims that she was the driving force behind the change made in January.
Peptides have been of particular interest to FDA under HHS Secretary Robert Kennedy Jr., who has advocated for more widespread use. Reuters reported that the Office of Management and Budget (OMB) is reviewing a new proposed FDA rule to allow easier compounding of certain peptides, following a controversial recommendation by an FDA panel to loosen restrictions on them.
FDA finalized two guidances on blood donation: one on donor blood pressure and pulse eligibility requirements and another on blood and blood component donations. In both guidances, the biggest change from the draft versions was that the agency clarified the circumstances under which it would exercise its regulatory discretion not to act against blood establishments for failing to comply with certain regulatory requirements.
FDA has added four more videos to its 10-video series for patients and healthcare providers to address opioid use disorder (OUD). The campaign, titled Prescribe with Confidence, includes new videos featuring Amy Techau, a rural community mental health nurse practitioner, who discusses evidence-based treatments, compassionate care, and patient recovery stories.
Drugs & Biologics
An expanded indication for Altor BioScience's cancer drug Anktiva (nogapendekin alfa inbakicept-pmln) has been approved to treat adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC). FDA had previously only approved the drug to treat those with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors that included patients with high-grade papillary-only tumors.
Alcon's eye drop Brytly (apraclonidine, 0.125%) has been approved as the first nonprescription eye drop containing apraclonidine to treat eye redness from minor irritations. The agency noted that the nonprescription eye drops are approved only for patients 12 and older and shouldn't be used more than twice a day.
Par Health has issued a voluntary recall of its argatroban injection, a thrombin inhibitor used to prevent or treat heparin-induced thrombocytopenia (HIT). FDA said the company found potentially life-threatening particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, in certain lots of the drugs.
Medtech
The Center for Devices and Radiological Health (CDRH) will host a hybrid conference on 22 October as part of the FDA Grand Rounds series to discuss the center's Real-World Evidence (RWE) Program. Top officials, including CDRH Director Michele Tarver; Sanjula Jain-Nagpal, FDA associate director of policy and research strategy; and Daniel Caños, director of CDRH's Office of Product Evaluation and Quality (OPEQ), will be presenting at the meeting.
A previous early alert for Medline's convenience kits that included BD ChloraPrep applicators was upgraded to a class I recall by FDA. The agency said that Medline has sent letters to customers advising them to cease use of the kits due to concerns that they may be prone to fungal contamination under certain environmental conditions.
FDA also issued an early alert about certain Edwards Lifesciences delivery systems used for SAPIEN M3 transcatheter mitral valve replacements, citing concerns that the balloons may burst during inflation. The company has asked customers to cease using the products and has so far reported one death and one serious injury related to the issue.
The Focused Ultrasound Foundation and FDA are co-hosting a public hybrid workshop on 10 November to discuss developing transcranial ultrasound devices for neurological and psychiatric uses. The workshop is described as a research roundtable in which expert stakeholders will discuss topics including safety considerations and patient risks, nonclinical assessments, clinical trial design, and more.
CDRH reminded stakeholders to comment on a discussion paper published in August regarding the regulation of generative AI-enabled devices. Stakeholders have until 19 October to comment on the discussion paper that addresses questions such as risk assessments, premarket evaluations, post-market monitoring, and other issues related to genAI.
