This Week at FDA: RTO challenges, measles response criticism, and FDA’s new infant formula plan

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 faced a variety of challenges as they returned to the office, former public health heads criticized the administration's response to the ongoing measles outbreaks, and the Department of Health and Human Services and FDA launched a joint operation to shore up the nation’s infant formula supply.

FDA staff with a duty station within 50 miles of the agency’s headquarters in Silver Spring, MD, or its field offices around the nation were ordered to return to the office this week under the Trump administration’s return-to-office order. Workers at the White Oak campus headquarters faced a shortage of parking spaces, office space, and equipment, as well as long commutes and security lines. Several FDA staff members told Focus that the conditions were so bad that they are either looking to find another job or know of colleagues who plan to leave the agency.

Reuters reported that, according to sources, the White House is reviewing downsizing plans submitted by federal agency heads last week that are expected to result in the mass firing of thousands of federal workers in the coming weeks. One of the sources said the administration wants to complete the reduction in force process by the end of September.

STAT reported that former FDA Commissioner Scott Gottlieb criticized the Trump administration's handling of the national measles outbreak and its plans to improve the infant formula supply during STAT’s Breakthrough Summit East. During the meeting, Tom Frieden, former director of the Centers for Disease Control and Prevention, also criticized the administration's measles response.

FDA and HHS announced the launch of Operation Stork to increase oversight of infant formulas. The agency is taking steps such as requiring a review of infant formula nutrients, increasing testing for heavy metals and other contaminants, and conducting research with the National Institutes of Health to study health outcomes associated with infant formula.

FDA also launched an online database this week called the Chemical Contaminants Transparency Tool (CCT Tool). The database lists contaminant levels, including tolerances, action levels, and guidance levels, used by the agency to evaluate potential health risks of contaminants in foods.

HHS Secretary Robert Kennedy Jr renewed the public health emergency (PHE) declaration for the national opioid crisis for another 90 days, ensuring the department can continue to use expanded authorities to respond to the crisis. Under the PHE, HHS has been able to collect certain voluntary information and expedite the development of substance use disorder treatments.

Drugs & biologics

FDA delayed implementing a rule on nonprescription drug products with an additional condition for non-prescription use (ACNU), which would establish certain product requirements, including application, labeling, and postmarket reporting requirements. The rule was intended to go into effect on 27 January but was postponed to 21 March after President Trump issued an executive order that froze new rules and regulations from going into effect. Implementation of the rule is now postponed until 27 May.

The Center for Drug Evaluation and Research (CDER) will host its two-day 2025 Generic Drugs Forum starting on 9 April in Rockville, MD. FDA said the hybrid meeting is meant to help educate prospective and current applicants to submit high-quality premarket submissions.

CDER also published its monthly and quarterly activity reports for its generic drug program. In January, the agency received 39 submissions, approved 63 ANDAs, and issued 123 complete response letters.

Merck's cancer drug Keytruda (pembrolizumab) with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy was approved as a first-line treatment for locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). The drug was granted accelerated approval and orphan drug designation.

FDA published the over-the-counter (OTC) monograph drug facility fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year 2025. FY 2025 fee rates for MDF and contract manufacturing organization facilities are $37,556 and $25,037, respectively.

Alnylam Pharmaceuticals announced that FDA had approved the supplemental new drug application (sNDA) for its RNAi drug Amvuttra (vutrisiran) to treat cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent heart failure visits. The expanded indication for Amvuttra makes it the first and only drug approved to treat ATTR-CM and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.

FDA published a slew of warning letters this week to several drugmakers related to violations of current good manufacturing practices (cGMP), including Aspen Pharmacare. Among the complaints, the South African drugmaker was cited for failing to take proper steps to prevent microbiological contamination of drugs meant to be sterile.

Medtech

FDA announced the addition, withdrawal, correction and revision of recognized consensus standards that medtech sponsors can refer to in the premarket submissions. The standards cover a wide range of devices and topics from anesthesiology to sterility.

Medtronic Neurovascular has initiated a class I recall of 027 Compatible Pipeline Vantage Embolization Devices and updating use instructions for 021 Compatible Pipeline Vantage Embolization Devices after receiving reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures to treat bulges in the artery walls of the brain. The products could cause adverse events, including thrombosis, stroke, or death.

Smiths Medical has initiated a class I recall of its ProPort Plastic Implantable Ports used to access veins due to a manufacturing defect that may cause the devices to separate. The defect could delay or disrupt treatment, leak medications such as chemotherapy, or cause fatal air embolisms.

Calyxo has sent an Urgent Device Field Correction notice to healthcare providers about a potential issue with its CVAC System (CVAC Aspiration System and CVAC Image Processor) used during endoscopic urological procedures to treat and remove urinary stones. The company has found that in some cases, patients with thick fluid in their kidneys at the beginning of the procedure may suffer reduced fluid outflow that can cause high pressure in the kidney and potentially lead to death. So far, the company has reported one death associated with the problem.

Becton, Dickinson and Company (BD) has issued a class I recall for its BD Alaris Systems Manager and Care Coordination Engine Infusion adapter software after the company found a risk for outdated automated programming requests to load on the devices. The company said that if the outdated requests are loaded and the rate or dose change is accepted, patients could receive inaccurate treatments, including over- or under-infusion.

This Week at FDA: RTO challenges, measles response criticism, and FDA’s new infant formula plan

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