This Week: Senate HELP to vote on Overton, FDA shelves CNPV, 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, we learned that the Senate health committee has scheduled a vote to advance the nomination of President Trump’s pick for FDA commissioner, that the FDA has shelved a controversial drug voucher program, and that it has warned of risks of a rare eye condition resulting from the use of GLP-1 products.
The Senate Health, Education, Labor and Pensions (HELP) committee announced it will vote on Heidi Overton's nomination to lead the US Food and Drug Administration (FDA) on Wednesday. If the vote passes, her nomination will move to the full Senate for confirmation. According to Politico, several key Republican senators, including outgoing committee chair Bill Cassidy (R-LA), have said they haven't decided whether to support her.
Politico also noted that acting FDA Commissioner Kyle Diamantas is expected to leave the administration at the end of the year. A source said that if Overton is not confirmed, the administration may ask Sara Brenner, the former acting FDA commissioner, to return in an acting capacity.
Reuters reported that, according to anonymous sources, the FDA has shelved the Commissioner's National Priority Voucher (CNPV) program, created by former FDA Commissioner Marty Makary and touted by the Trump Administration to significantly speed drugs to market that address specific national priorities. Critics of the program have questioned its legality and say it could be used to give preferential treatment to drugmakers that comply with President Donald Trump's demands.
FDA has issued a statement requiring a safety labeling change for glucagon-like peptide-1 (GLP-1) receptor agonists, warning users of a potential increased risk of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the diabetes drugs that have become popular for weight loss. The agency noted that while NAION can cause acute, painless vision loss in one eye that may progress to permanent vision loss, it is a rare condition.
FDA issued a final guidance on validation of certain in vitro diagnostics for emerging pathogens during a public health emergency this week. It details the recommended test data and information sponsors should submit with their pre-Emergency Use Authorization (EUA) submissions.
FDA published the updated over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists. The agency named almost 80 pages' worth of facilities that have not paid their OMUFA fees.
Drugs & Biologics
FDA approved Bayer's drug Sunharbo (asundexian) as the first factor XIa (FXIa) inhibitor to help reduce the risk of stroke in adults after a recent mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. The agency noted that the drug received fast-track and priority review.
Eugia US announced a recall of vials of vancomycin hydrochloride after glass particulates were found in its injections, according to the FDA. The company said it has notified its distributors and customers about the issue and warned them that glass particulates may cause life-threatening embolisms.
EMD Serono's cancer kinase inhibitor Pimjetmi (pimicotinib) was approved by FDA to treat adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity. The drug was given fast-track and breakthrough therapy designation.
Postmarket adverse event reports reviewed by FDA have found safety signals of malignancies, including confirmed reports of product-related insertional oncogenesis involving the GLI1 (Glioma-Associated Oncogene Homolog 1) gene, in some patients treated for spinal muscular atrophy (SMA) with Novartis' intravenous infusion adeno-associated virus (AAV) vector-based gene therapy Zolgensma (onasemnogene abeparvovec). The agency said that it is continuing to investigate the issue and, despite risks of tumors associated with Zolgensma and its intrathecal injection version, Itvisma, the benefits of the treatments continue to outweigh their risks for their approved uses.
Medtech
The Center for Devices and Radiological Health (CDRH) published a discussion paper on evaluating the benefits and risks of robotic medical devices that have autonomous or remote teleoperation capabilities. The agency said its intent is to promote early, open dialogue on the topic, especially regarding issues such as terminology and risk mitigation.
FDA issued an early alert for Intersurgical's 22mm smoothbore breathing tubes and systems after the company found that a manufacturing error had caused the soft connectors on some products to disconnect from the tubes, which could lead to loss of ventilation and serious adverse events, including brain damage and death. Intersurgical has sent letters to customers to remove certain lots of the products from use.
FDA also issued an early warning for Arrow International products that include its Spring Wire Guide after the company found quality issues that could cause the hydraulic coating to break apart and be released into the patient's bloodstream, leading to life-threatening embolisms. Arrow International, a subsidiary of Teleflex, has sent letters to customers with a list of products to remove from shelves that may have been affected.
FDA proposed reclassifying immunohistochemistry (IHC) test systems indicated for use with a corresponding approved oncology therapeutic product from class III products to class II products with special controls. The agency also proposed mitigation measures to satisfy the special controls requirements, including certain design verifications and validations.
After issuing an early alert last month, FDA has upgraded the recent recall for Cardinal Health presource packs that include BD Alaris Pump infusion sets to a class I recall. The company said some Alaris Pumps have been found to underperform and could be life-threatening, and it has sent its customers updated instructions for use on how to handle the situation.
