This Week at FDA: Upcoming Senate markup, first OTC CGM for children, 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. A key Senate committee will consider several important pieces of legislation that affect the healthcare products industry next week, FDA has approved a new sunscreen for the US market, and the agency published several guidances, including one on developing human genome editing products.

The Senate Committee on Health, Education, Labor and Pensions scheduled a markup of three FDA-related bills on 17 June. They include the Biosimilar Red Tape Elimination Act, intended to expedite biosimilars' market entry; the Medication Affordability and Patent Integrity Act, to reform the drug patent system; and the Ensuring Timely Access to Generics Act, to update oversight of the citizen petition process that has been used to stall generics' market entry.

Dexcom's Stelo Glucose Biosensor System has been cleared by FDA as the first over-the-counter integrated continuous glucose meter for patients as young as two years old who do not use insulin. The product had previously been indicated for those over 18 and uses a wearable sensor paired with an application on a smartphone or other smart device to continuously measure, record, analyze, and display glucose readings.

For the first time in decades, FDA has expanded the list of sunscreen ingredients with the addition of bemotrizinol to the over-the-counter (OTC) monograph for sunscreen ingredients. The addition is the first since the late 1990s, according to FDA. The agency noted that bemotrizinol had been used in Europe and other countries for decades.

In anticipation of the Generic Drug User Fee Amendments Science and Research Public Workshop held 8 and 9 June, Iilun Murphy, director of the Office of Generic Drugs at the Center for Drug Evaluation and Research (CDER), and Mike Kopcha, director of the Office of Pharmaceutical Quality at CDER, penned a blog post on how the agency regulates generic drugs and highlighted some of the agency's recent decisions, such as publishing a slew of product-specific guidance. They emphasized that the agency strongly supports bringing drug manufacturing back to the US to ensure supply chain security and resilience, and that it is working with stakeholders to speed products to market.

FDA sent out its Notification of Annual BsUFA Fees correspondence as part of the FY 2027 Biosimilar User Fee Amendments (BsUFA) program, detailing the user fees manufacturers need to submit. The agency reminded companies that, in line with an executive order, payments must be made from a US bank by electronic check, credit card, or wire transfer.

FDA published a draft guidance on next-generation sequencing-based methods used in nonclinical studies that may be used to support the start of investigational human genome editing (GE) product clinical trials. The agency said the recommendations in the guidance complement nonclinical, clinical, and CMC considerations in a similar 2024 GE guidance.

FDA also published a draft guidance for applicants of new drug applications (NDA) when submitting patent information to their NDA using a Form FDA 3542a or Form FDA 3542. A Form FDA 3542a is submitted when an NDA applicant submits information on a patent that claims a drug substance, drug product, or method of using the drug that is the subject of an unapproved original NDA, amendment to an NDA, or supplement to an NDA. A Form FDA 3542, on the other hand, is for NDA holders who submit the same information, but only for an approved NDA or an approved supplement to an NDA.

After receiving similar requests for more time, FDA also extended the comment period for a request for information on repurposing drugs for unmet needs. The agency has extended the comment period to another 30 days until 13 July.

As part of the Trump administration's efforts to remove unnecessary regulations, FDA said it is amending regulations to update organizational and contact information on its website. The agency said information on the FDA’s organization, including its central and field offices, will be listed in its staff manual guides, and relevant contact information for FDA offices, including email addresses, will be available on its website.

Drugs & biologics

A label update to GlaxoSmithKline's OTC weight loss drug alli (orlistat) has been approved by FDA to include a rare risk of acute kidney injury. Users are told to talk to their healthcare provider if they've ever had kidney disease or kidney stones, and to stop using the drug if they develop symptoms of kidney injury or kidney stones.

CDER's Small Business and Industry Assistance (SBIA) office will host three hour-long virtual training sessions for staff at academic medical centers to learn about federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov. The sessions will take place on 14, 22, and 30 July and include a pre-recorded training portion followed by a live Q&A session with agency staff.

The comment period for a request for information from FDA seeking feedback on several guidances on scale-up and postapproval changes for specific dosage forms has been extended for another 30 days to 13 July. The agency said it made the decision after receiving stakeholder requests for more time to submit comments.

Becton, Dickinson and Company has issued a recall for specific lots of its ChloraPrep Clear 1 mL single sterile and FREPP Clear 1.5 mL applicators with paper lidding due to concerns of fungal contamination that may lead to growth of the fungus Aspergillus penicillioides. FDA said the fungus introduced on the skin or bloodstream could lead to a serious systemic infection, sepsis, illness, and death.

Medtech

Several medical devices have been classified by FDA as class II products with special controls via the de novo pathway, including combined acoustic and electrical external stimulation devices for the relief of tinnitus. The mitigation measures for the devices include conducting biocompatibility evaluations, performing clinical and non-clinical performance testing, and updating labeling information.

Simple point-of-care devices to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings were similarly classified to class II with special controls. The devices need to adopt mitigation measures such as labeling information updates, certain design verification and validation, and the use of specific specimen collection methods.

FDA also classified spinal muscular atrophy newborn screening test systems to class II devices with special controls. The agency requires the devices to undergo mitigation measures, including certain design verification and validation procedures and the publication of certain labeling information.

FDA has issued an early alert for certain Hamilton Medical coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators due to concerns that they may not perform as intended, leading to suboptimal gas flow. The company has reported four serious injuries due to the issue, but no deaths.

The FDA also issued an early alert about certain Baxter Volara System single-patient-use circuits that may leak air and medication from the nebulizer cup during therapy. The agency noted that the issue could lead to improper locking of the nebulizer after medication is added to the cup, which could adversely affect delivery of prescribed therapy, and so far, the company has reported one serious injury.