This Week at FDA: Califf urges DOGE to work with FDA, updates on Hurricane-related shortage concerns, 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 Robert Califf urged the incoming Trump administration to collaborate with his agency to find efficiencies, the agency provided updates on its work to mitigate drug and infant formula shortages, and more.

On Sunday, Califf published an op-ed in the Wall Street Journal imploring Elon Musk and Vivek Ramaswamy to work with his agency to improve efficiency. President-elect Donald Trump has said Musk and Ramaswamy will head an advisory body dubbed the Department of Government Efficiency (DOGE), which has been tasked with making recommendations for significant cuts to federal spending and regulations.

Former FDA Commissioner Scott Gottlieb, who served under Trump during his first term, told CNBC he is concerned that if Robert F. Kennedy Jr. is appointed secretary of the Department of Health and Human Services (HHS), his views on vaccines “will cost lives in this country.”

Gottlieb also noted that Trump's nominee for director of the Centers for Disease Control and Prevention (CDC), former House Rep. Dave Weldon (R-FL), has a record of anti-vaccine sentiment, which could compound RFK Jr.'s effect. He said he had raised his concerns with congressional lawmakers and expressed some skepticism about RFK’s ability to get confirmed in the Senate.

FDA provided more information on product shortages caused by Hurricane Helen's impact on Baxter's manufacturing facility in North Cove, NC. The agency said Baxter is releasing a lot of sodium citrate 4% (250ml) manufactured at the facility, South Korean drug manufacturer HK Inno.N Corporation has been granted permission to import certain products, and the American Society for Parenteral and Enteral Nutrition (ASPEN) has issued a tool to help convert dextrose injections to glucose 50% injections to alleviate the drug shortages.

After facing severe criticism for its handling of the 2022 infant formula crisis, FDA has drafted guidance that calls on manufacturers to notify the agency when they permanently discontinue producing infant formula or foresee a production interruption. The agency added that the guidance was informed by its recent experience with infant formula shortage and is intended to improve the resiliency of the infant formula market.

FDA also finalized a guidance on standardizing the content of electronic submissions of new drug applications (NDA) and biologics license applications (BLA) for bioresearch monitoring (BIMO) inspections. The draft of the guidance was published in June, and the medtech industry raised concerns about protecting sensitive information that could affect their data privacy and security.

Kimberlee Trzeciak; FDA deputy commissioner for policy, legislation, and international affairs; penned a blog post about her recent trip to India to attend the World Health Organization’s (WHO) 19th International Conference of Drug Regulatory Authorities (ICDRA) meeting. In her post, she highlighted the work of the FDA and other regulators in working toward global harmonization.

Drugs & biologics

FDA will convene its Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee on 5 February to discuss prospective and retrospective studies looking at the risks and predictors of opioid misuse and overdose. While the studies have been completed, the agency will publish its own background materials before the meeting.

Following several cybersecurity attacks on blood establishments, FDA has published a safety notice to the establishments on cybersecurity best practices. The agency emphasized that blood establishments must be aware of their legal obligations, relevant guidance, proper record-keeping, and advised them to contact it for further information.

Merus N.V.'s cancer drug Bizengri (zenocutuzumab-zbco) has been granted accelerated approval to treat patients with non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma. FDA noted that it is the first drug approved to treat patients with the two forms of cancer that have neuregulin 1 (NRG1) gene fusion.

AstraZeneca's limited-stage small cell lung cancer (LS-SCLC) drug Imfinzi (durvalumab) was approved for adult patients whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy. FDA noted that the drug had received priority review and breakthrough designation and was reviewed under the Oncology Center of Excellence's Project Orbis.

Medtech

FDA published November 2024 data trends from its Global Unique Device Identification Database (GUDID). It received more than 4.5M records with unique device identifiers (UDI) through September 2024; up about half a million records from the previous year.

FDA announced this week it had approved Abbott's Esprit BTK (Below-the-Knee) Everolimus Eluting Resorbable Scaffold System in April. The device is intended to treat chronic limb-threatening ischemia and shouldn’t be used by patients who cannot tolerate blood-thinning drugs, everolimus, polylactic acid, platinum compounds, or other chemicals in the scaffold.

Cardinal Health has issued a class I recall for certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs used to deliver insulin. According to FDA, the company has found some of the devices are incompatible with needleless intravenous (IV) connectors, which could prevent patients from properly receiving their medication.

GE Healthcare has updated instructions for using its Giraffe OmniBed Carestation CS1 and Giraffe Incubator Carestation CS1 devices as part of its class I recall. FDA noted that the company initiated the recall after some incubators registered high levels of formaldehyde, which needed a week of operation to clear the toxic gas before neonates could be placed in them. The new instructions state that devices manufactured after 5 September 2023 do not need to run for a week before use.

As required by the 21st Century Cures Act, FDA published its biennial report on the risks and benefits of non-device software, such as those used for processing and maintaining financial records, claims or billing information, and scheduling. As with previous reports, the agency said such software has mostly benefited patient care.

This Week at FDA: Califf urges DOGE to work with FDA, updates on Hurricane-related shortage concerns, and more

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