This Week at FDA: Makary reflects on first year, FDA working to lift peptide restrictions, 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 Commissioner Marty Makary reflected on his first year, FDA is reportedly looking to drop peptide manufacturing restrictions, and more.

It’s been a year since Makary took the reins as FDA commissioner, and Agency IQ did a comprehensive analysis of what he said he wanted to accomplish during his tenure. Some of his notable achievements over the past year include publicly releasing complete response letters (CRL), creating the Commissioner’s National Priority Voucher (CNPV) pilot program, and fulfilling certain key objectives of Health and Human Services (HHS) Secretary Robert Kennedy Jr., including labeling changes for acetaminophen that controversially link its use in pregnancy to autism. AgencyIQ further noted that FDA has fully implemented eight major policy announcements made by Makary and partially implemented another 16. Eight additional policy announcements have seen little progress.

AgencyIQ also reported in its FDA Today: Life Sciences newsletter that, according to FDA, the agency conducted 233 unannounced foreign inspections in FY2025, which is about 45% more than in FY2024. That meant that 90% of FY2025 inspections were announced, down slightly from 94% in FY2024.

One year ago this week, the Trump Administration severed 10,000 HHS workers, including 3,500 FDA employees, according to STAT News. It reported that it was officially Makary's first day as commissioner, and on the one-year anniversary, he gave a speech to agency staff acknowledging a "challenging start" to his tenure. While he thanked staff for their work and emphasized the need to ensure they are adequately resourced, he did not mention issues such as the fact that long-time agency experts have been pushed out over the past year and that their opinions have been overruled.

The New York Times reported this week that FDA is working to lift restrictions on compounding pharmacies from producing more than a dozen injectable peptides that were banned in 2023 due to safety concerns. According to the Times, the drugs have been promoted by Kennedy as good for healing, but critics say they have not been proven to be effective and instead come with significant risks.

Drugs & Biologics

Eli Lilly's Foundayo (orforglipron) is the fifth product and first new molecular entity (NME) approved under the Commissioner's National Priority Voucher (CNPV) pilot program. FDA noted that the drug, indicated for overweight and obesity in adults, was approved only 50 days after the marketing application was filed and 294 days before its Prescription Drug User Fee Amendment (PDUFA) target date.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are seeking public feedback on digital health technologies (DHTs) for remote data acquisition intended for clinical research. The agency said that, as part of PDUFA VII, it wants information on the challenges and opportunities sponsors face when using DHTs for medical research.

CBER has updated its standard operating policy and procedure (SOPP) for filing applications when an applicant protests a refusal-to-file (RTF) action. The agency noted that the revision includes taking our reference to Appendix A of the SOPP and adding applicable regulations.

FDA issued a public safety alert for Amgen's drug Tavneos (avacopan), used to treat severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, for drug-induced liver injury (DILI). The agency said it has received reports of vanishing bile duct syndrome (VBDS) and fatalities associated with the drug and is continuing to monitor postmarketing cases, and recommended users look out for potential liver injury syndromes.

Richard Beger, branch chief at FDA's Division of Systems Biology in the Office of the Chief Scientist, will host a webinar on 9 April to discuss Systems Biology omics and biomarker concepts. The agency said he will present examples, including "metabolomics and miRNA analysis of serum during acetaminophen-induced liver toxicity, proteomic analysis of serum to predict kidney recovery from dialysis, baseline proteomics analysis of blood from patients receiving doxorubicin treatment, and method for discovery and validation of miRNA-proteins pairs in plasma associated with respiratory disease."

Medtech

The Center for Devices and Radiological Health (CDRH) published minutes from its meeting with medtech industry representatives on 11 March as it negotiates the next iteration of the Medical Device User Fee Amendments program, MDUFA VI. According to the minutes, both sides have come to an agreement on issues such as review consistency, the Total Product Life Cycle Advisory Program (TAP) 2.0, trigger reform, carryover funds, and operating reserve, but still need to hash things out over issues such as data source development used for real-world evidence (RWE) and periodic reporting.

FDA published its first quarter FY2026 third-party review organization performance report, which shows that in Q1, third-party review organizations accepted 23 510 (k) submissions. The total number of submissions has been declining over the past few years, with 77 in FY2023, 68 in FY2024, and 67 in FY2025.