This Week at FDA: New ConOps for drug inspections, AI policy proposal, 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 announced that its drug center and inspections office have agreed to a new concept of operations (ConOps) for coordinating inspections and other compliance activities, a senator released draft legislation that would give FDA new authorities for overseeing artificial intelligence (AI), and the agency has removed a boxed warning from the labels of estradiol patches.
On Thursday, FDA announced an agreement between CDER and the Office of Inspections and Investigations (OII) that covers preapproval, postapproval, surveillance, and for-cause inspection processes for human drugs, replacing a previous version from 2017. Key updates of the ConOps 2.0 include incorporation of Remote Regulatory Assessments (RRAs) and Mutual Recognition Agreement (MRA) inspection reports as evaluation tools. FDA said that “ConOps helps CDER and OII to more effectively manage the growing complexity of the pharmaceutical manufacturing landscape.”
Sen. Bill Cassidy (R-LA), the outgoing chair of the Senate Committee on Health, Education, Labor and Pensions (HELP), has released a discussion draft of a bill, called the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act, or PATIENT AI Act. The bill aims to when an AI-based technology and software tools are subject to oversight by FDA or the Office of the National Coordinator for Health Information Technology (ONC). Additionally, the bill would give FDA new authorities to review changes to software on a rolling basis.
This legislation would make statutory changes intended to support “a more predictable and consistent framework to review and reimburse for AI-based technologies,” according to a press release.
FDA announced on Friday that it is removing warnings from the labels of three estradiol transdermal patches, as reported by The Guardian. The agency did not hold an advisory committee meeting to discuss this change and offered limited details during a press briefing. This announcement comes after the removal of black box warnings from six menopause treatments in February. According to Reuters, rising demand for estrogen patches has not kept pace with supplies, leading to shortages.
HHS Secretary Robert Kennedy Jr.'s new enforcement discretion policy on compounding six unapproved peptides may encounter resistance from various states, according to a report in Politico's Prescription Pulse. States are not obligated to comply with this policy, which was announced this week. "There’s 50 different states that all have 50 different opinions," Will Douglas, owner of Cody Drug, a compounding pharmacy in Texas told the Pulse. "For the next couple of weeks, it’s going to be touch and go with the rollout.”
FDA announced a proposed rule on Thursday to change the nutrient levels in infant formula in three phases. In the first phase, the FDA proposes adjustments to the levels of iodine, vitamin A, vitamin D, and manganese. Additionally, after a comprehensive assessment, the agency confirmed that four other nutrients—chloride, selenium, potassium, and sodium—are at “appropriate” levels. This initiative is part of Operation Stork Speed, aimed at enhancing the quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply. FDA stated that this is the first update to infant formula regulations since 1998. The deadline for submitting public comment is 27 February 2027.
Drugs and Biologics
FDA has released a question-and-answer (Q&A) document aimed at clarifying issues related to the implementation of the International Council for Harmonisation's (ICH) guidelines. These include E14, which focuses on the clinical evaluation of QT/QTc interval prolongation and the proarrhythmic potential of non-antiarrhythmic drugs, and S7B, which addresses the nonclinical evaluation of potential delayed ventricular repolarization (QT interval prolongation) for human pharmaceuticals. The updated Q&A document includes revisions to Questions 5.1, 6.1, and 6.3 for E14, along with new and revised questions in Sections 1 and 3 of S7B.
FDA is asking for scientific data to determine whether the pH cycling test model, a non-animal testing procedure, can be used to test fluoride toothpaste under OTC Monograph M021, which covers over-the-counter cavity-prevention drug products. The model mimics tooth decay and the role of fluoride toothpaste in its prevention.
Medical Devices
FDA on Friday classified three devices as Class II products with special controls, including spinal imaging systems, over-the-counter device to assess the risk of sleep apnea, and software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer.
FDA has issued an early alert to inform customers about the discontinuation and market withdrawal of all Medline brand beds and their associated accessories. This includes homecare beds, bariatric beds, long-term care beds, pendants, accessories, and replacement parts. There is a potential risk of entrapment or asphyxiation if the bed is used with loose or unstable rails. Such risks may lead to patient injury or death. Medline has reported two fatalities and 16 serious injuries related to these concerns.
