This Week at FDA: Peptide dispute, clinical trial legislation, 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, a drug safety group filed a citizen petition with FDA opposing the marketing of unapproved compounded peptides, a bipartisan bill was introduced to reform clinical trial participation and review, and more.
HHS Secretary Kennedy Jr. on Tuesday said the Trump administration aims to establish a state-regulated marketplace for certain unapproved peptides, according to Inside Health Policy. He argued that allowing access to these peptides through 503A compounders would offer additional safety protections for consumers might otherwise purchase from unregulated gray- or black-market sellers.
At the same time, FDA’s potential move to enable the compounding of certain peptides has come under fire from The Partnership for Safe Medicines, a drug-safety advocacy group, which filed a citizen petition this week, asking the agency to stop the compounding of certain peptides, according to Politico’s Prescription Pulse. The group contends that compounding the peptides is illegal and poses safety risks.
HHS and FDA submitted an interim access policy to OMB, which would temporarily allow specialized compounding pharmacies to produce these peptides pending permanent rules. Over the summer, an FDA advisory committee recommended adding six peptides: BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax to the 503A compounding list.
Legislation introduced on Thursday by Rep. Jake Auchincloss (D-MA) and Rep. Morgan Griffith (R-MA) aims to simplify the process for patients to participate in clinical trials and reduce the time it takes to start them, according to a report by CNBC. The proposed legislation, known as the Faster Clinical Trials Act, also seeks to advance the use of human-based models, artificial intelligence, and other alternatives to animal testing, and would attempt to address some of the common causes of clinical holds to reduce delays.
The legislation also proposes a Center for Clinical Trial Innovation (CCI) within the Center for Drug Evaluation and Research to lead the Cures in Care Initiative, which is meant to integrate research into routine care, according to a statement from Rep. Auchincloss’s office. The bill calls for the CCI to establish at least three trial networks within its first year.
Politico reported that pharmaceutical companies are spending record amounts lobbying policy makers, with new federal filings showing Eli Lilly, Merck and Regeneron reporting spending more on lobbying in Q3 2026 alone than they have in over a decade. Eli Lilly reportedly spent more than $9.6 million so far this year.
Calley Means, a senior adviser to HHS Secretary Kennedy, handed in his resignation on Thursday, reportedly due to delays in implementing food policies tied to the Make America Healthy Again movement, The Hill reports.
Drugs and Biologics
FDA announced the approval of GSK’s Hibsago (bepirovirsen) injection to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis. The agency said Hibsago is the first FDA-approved antisense oligonucleotide to treat this condition.
FDA’s Office of Generic Drugs (OGD) has identified several key priorities for generic drug research in FY 2027. These priorities include focusing on methods to address nitrosamine impurities and improving the efficiency of equivalence approaches for complex active ingredients. These goals were detailed in OGD’s annual report, which identifies eight areas of interest.
On Monday, FDA granted accelerated approval for a new use of GSK’s immunotherapy Jemperli (dostarlimab-gxly) to treat locally advanced rectal cancer. This is an alternative to current treatments that can have a lasting impact on patients’ daily life. Patients with locally advanced rectal cancer often receive chemotherapy and radiation prior to surgery, which can affect bowel, urinary, and sexual function, as well as fertility.
FDA has released a final guidance on submitting clinical trial data to assess the ability to operate a motor vehicle. The document outlines the technical specifications for submitting data from a clinical trial designed to evaluate how a drug or biological product may affect driving ability, which is necessary to support a marketing application.
FDA warned consumers about counterfeit over-the-counter eye drops found in Florida and Georgia. These products may also be in Louisiana, Mississippi, North Carolina and possibly other states. DLC Laboratory tested two counterfeit products and found bacterial contamination.
CDER released its annual report for the Accelerating Rare disease CURES (ARC) program. The report discusses the program’s accomplishments in scientific and regulatory innovations, engagement and education, and operations.
FDA will be hosting a public virtual workshop 12-19 November on maintaining treatment for ovarian cancer. The workshop will delve into such topics as interpreting progression-free survival (PFS), use of other efficacy endpoints, and safety and dosing regimen considerations.
The Food and Drug Law Institute (FDLI) will host its 2026 advertising and promotion for medical products conference on 28-29 October in Washington, DC. The meeting will convene representatives from federal agencies and industry to explore government initiatives regarding medical product advertising and promotion and to explore enforcement trends.
FDLI will also host a one-day educational conference on orphan drugs in Boston on 2 December. The meeting will examine the legal and regulatory issues that are unique to orphan drugs and rare disease therapies.
Medical Devices
The Center for Devices and Radiological Health (CDRH) has launched a new webpage on predetermined change control plans (PCCPs). The webpage discusses the value of PCCPs, modifications that can be made to PCCPs, and the types of marketing submission types that can include a PCCP.
CDRH announced that Nova Biomedical has sent a letter to affected customers, advising them to remove its StatStrip glucose hospital meters from use or sale until a new software update becomes available.
