This Week at FDA: FDA staff raise concerns about peptide conflicts, top Democrat wants DOGE investigation, 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, FDA staff raised concerns internally about conflicts of interest ahead of a panel on peptides next week, a top Democrat is seeking an investigation into the effects of the DOGE cuts on FDA, and the agency’s acting commissioner backtracked on some policies issued by his predecessor.

The Washington Post reported on Friday that some FDA officials raised concerns that some newly instated experts on the Pharmacy Compounding Advisory Committee may have significant commercial conflicts of interest ahead of a 23-24 July meeting to discuss whether seven peptides should be eligible for bulk production by compounding pharmacies. The peptides are purported to treat ulcerative colitis, obesity, insomnia, and other conditions. The officials said the panel members in question have worked for peptide-related businesses and clinics and have promoted peptides.

Politico reported that Rep. Frank Pallone (D-NJ) has asked the Government Accountability Office to evaluate the impact of last year's mass firings of FDA staff by the Department of Government Efficiency (DOGE) on FDA staffing and the use of user fees. The publication also reported that consumers are finding it easier to stumble onto websites that sell knock-off versions of Eli Lilly's next-generation investigational weight-loss drug retatrutide.

Acting FDA Commissioner Kyle Diamantas has clarified that certain policies disseminated in medical journals by his predecessor Marty Makary are not official agency policy or guidance. In a letter to Rep. Diana DeGette (D-CO), he assured the ranking member of the House Energy and Commerce health subcommittee that some of the agency's major policy announcements from the past year that circumvented the agency's good guidance practices are not to be treated as guidance or policy.

Diamantas also published a blog post that echoed much of the messaging from his recent Fourth of July post, emphasizing FDA's key role in ensuring Americans have access to safe and effective healthcare products. In the latest post, he outlines four pillars that are foundational to the agency's mission: maintaining global leadership in innovation, advancing national health security, increasing access to affordable medical products, and preventing chronic diseases while promoting the wellness of Americans.

The Duke-Margolis Institute for Health Policy and FDA are co-hosting a virtual public meeting on 1 September to discuss establishing the Quantitative Medicine Innovation Network (QMIN), intended to promote the use of quantitative medicine research to develop new drugs. They said the meeting will allow participants to discuss scientific and regulatory gaps that the network can address to drive quantitative medicine research.

The Small Business and Industry Assistance at FDA's drug center is hosting a hybrid drug registration and listing workshop on 29 September, where regulators will update the industry on issues such as current validation rules, regulatory requirements, and the compliance framework. The agency said it will also discuss compliance strategies for drug amount reporting requirements and provide an opportunity for questions.

FDA is hosting a hybrid public meeting on 14 September in partnership with other federal agencies to discuss future therapeutic areas that may benefit from psychedelic drugs. The announcement comes on the same day that the agency finalized a 2023 guidance that clarifies its thinking on the topic, based on industry feedback, especially regarding clinical and safety considerations in the design of clinical trials.

In addition, FDA also finalized a guidance this week on evaluating in vivo bioequivalence (BE) for topical corticosteroids. The agency noted that it provides recommendations to sponsors of generic topical dermatologic corticosteroids the in vivo pharmacodynamic approach to demonstrate the BE of topical corticosteroids, including appropriate pilot dose-duration vasoconstrictor response and pivotal vasoconstrictor BE studies.

Academic medical centers are encouraged to participate in a three-day virtual meeting hosted by FDA on 14, 22, and 30 July to discuss what they need to do to meet federal requirements to register clinical studies and report results to www.ClinicalTrials.gov. Each healthcare product center will make presentations during the three days to educate academic medical center staff and researchers about their obligations and how to avoid potential pitfalls.

FDA announced that stakeholders have until 1 August to submit applications for FY 2026 Small Business Requests. The application submission window for the next fiscal year's request also begins on 1 August.

Drugs & biologics

Merck Sharp & Dohme's daily drug Lipfendra (enlicitide) has been approved to reduce low-density lipoprotein cholesterol (LDL-C) in people with high cholesterol or those who have heterozygous familial hypercholesterolemia (HeFH), an inherited type of high cholesterol. FDA noted that it is the first oral therapy to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower bad cholesterol.

Eli Lily's cancer drug Retevmo (selpercatinib) was approved to treat patients as young as two with locally advanced or metastatic solid tumors with a RET gene fusion, diagnosed with an FDA-approved test, who have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. FDA noted that the drug initially received accelerated approval for adults in 2022 and for patients aged two years and older in 2024.

Celcuity's cancer drug Revtorpyk (gedatolisib) was also approved, in combination with fulvestrant, with or without palbociclib, to treat patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. FDA noted that the drug was reviewed under its Real-Time Oncology Review (RTOR) program.

Eisai’s amyloid beta-directed antibody Leqembi (lecanemab-irmb) has been approved for a new starting-dose regimen, administered subcutaneously, to treat Alzheimer's disease, making it the first treatment for the disease that patients can administer at home, either alone or with a caregiver. The drug had previously only been approved as an intravenous starting dosage, with the option for transitioning to intravenous or subcutaneous maintenance dosage after 18 months of treatment.

FDA has approved the first generic versions of Boehringer Ingelheim's cancer drug Gilotrig (afatinib) to treat metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations, as diagnosed by an FDA-approved test, and for the treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy. The agency added that the prescribing information for the generic drugs has the same warnings and precautions as the brand-name drug.

FDA published the latest meeting minutes from its discussions with industry representatives as it negotiates the next Biosimilar User Fee Act (BsUFA) program. During the June meetings, both sides discussed steps to modernize the biologics license application (BLA) review process, improve meeting management by possibly removing biosimilar initial advisory (BIA) meetings, and make changes to the third-party assessment process.

Medtech

FDA wants public input on how certain software that is excluded from agency oversight as medical devices under the 21st Century Cures Act can help promote patient safety, education, and competency. The agency said it will use the feedback, due by 13 August, to develop a report on the risks and benefits of non-device software functions, including those intended for administrative health facility support, wellness, and certain clinical support software.

FDA will host three virtual town halls over the next couple of months to discuss biocompatibility issues, including a 9 September town hall to discuss recent updates to ISO 10993-1(2025), "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The agency said it will share risk assessment approaches for evaluating biocompatibility endpoints for medical devices.

FDA will also host a virtual town hall on 23 September to discuss chemical characterization testing methodology to address biocompatibility endpoints for medical devices, focusing on the standards set by ISO 10993-18. Furthermore, the agency will host a town hall on 7 October to discuss toxicological risk assessments aimed at addressing biocompatibility endpoints for medical devices.

Several companies announced class I recalls this week, including Medtronic, which has removed certain lots of the Harmony Delivery Catheter System (DCS) used for the insertion of the Medtronic Harmony transcatheter pulmonary valve (TPV) from the market due to concerns that the tips may detach. FDA said that if that happens, it will require a secondary intervention to remove the tip, either by endovascular retrieval or surgical intervention.