This Week at FDA: Midterms may complicate Overton confirmation, influence user fee reauthorization, 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’re looking at some of the ways the midterm election results could impact FDA over the next two years, starting with the confirmation prospects for President Trump’s pick for FDA commissioner and how Democrats may use their newfound oversight powers.
With Democrats regaining control of both chambers of Congress, Trump’s nominee for FDA commissioner, Heidi Overton, may have a challenging path ahead, according to a report from FDA Webview. Republicans have a small window to confirm Overton before handing over the reins to Democrats in January; however, her nomination has still not been voted on by the Senate Health, Education, Labor and Pensions (HELP) Committee and several Republicans have expressed concerns about her views on vaccine policy and the abortion drug mifepristone.
Democrats' big win in both chambers means the party can take significant action on issues such as oversight and drug pricing and gives Democratic leaders more influence over FDA policies during the user fee reauthorization process next year, according to a report from Politico’s Prescription Pulse which cited lobbyists and former Hill aides. However, Politico notes that some policies retain bipartisan support, such as a recently introduced bill by Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA) that aims to expedite reviews for early-stage clinical trials.
A report from STAT indicates that the midterms will have significant implications for the upcoming user fee agreements. Sen. Bernie Sanders (I-VT), a major critic of the program, is expected to assume leadership of the HELP Committee, which has jurisdiction over user fee legislation. Although Sanders voted in favor of the legislation in 2022, he opposed it during the previous three funding cycles.
In the House, Rep. Frank Pallone (D-NJ) announced his intention to regain the chairmanship of the Energy and Commerce Committee in January, as reported by Politico. In a letter obtained by Politico, Pallone outlined his top health care priorities, which would include reversing Republican-led cuts to Medicaid benefits, lowering prescription drug prices for the private insurance market and ensuring nationwide access to reproductive health benefits, such as in vitro fertilization.
Robert Garcia (D-CA), the top Democrat on the House Oversight Committee formally announced his bid to chair the committee in a letter to colleagues on Thursday, according to a report in Politico. On election night, he told the Trump administration to “lawyer up.” Garcia previously told the news outlet in June that he plans to pursue investigations into HHS Secretary Kennedy Jr.’s conduct. He said he “wouldn’t rule out subpoena requests or articles of impeachment against Kennedy, depending on how potential investigations progress.” Sen. Angela Alsobrooks (D-MD), also a member of the Senate HELP Committee, has already said that Kennedy needs to go. “The time is now. RFK Jr. must resign or be fired. End of discussion,” she wrote on Wednesday.
Although the MAHA political movement experienced a defeat in the recent elections, its goals of preventing chronic diseases and advocating for healthier food, align with the health agendas of Democratic candidates such as Abdul El-Sayed, who is set to become Michigan's next senator, and Rob Sand, the incoming governor of Iowa, according to an opinion piece in Stat.
Drugs and Biologics
FDA on Thursday granted accelerated approval to Janssen Biotech’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) following platinum-based chemotherapy and immunotherapy. HNSCC is an aggressive and life-threatening disease with a significant unmet need for effective therapies.
FDA tentatively approved a generic version of Gilead’s Yeztugo (lenacapavir) the world’s only twice-a-year shot to prevent HIV, announced MedPage Today. This approval can expedite regulatory approval processes in other countries.
On Tuesday, FDA posted a warning letter to Guangdong Bangze Medicine Co., Ltd., in Guangdong Sheng, China, for “significant violations” of current good manufacturing practices (GMPS) in the firm’s production of over-the-counter drug products. Violations included failure to test samples of each component for identity and conformity with all appropriate written specifications.
On Tuesday, President Trump signed into H.R. 8205 into law, according to a White House announcement. The “Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026” extends and reauthorizes programs and research grants supporting ALS and other rare neurodegenerative diseases through fiscal year 2031.
Medical Devices
FDA on Friday classified the external mechanical stimulator for the relief of congestion into class II products with special controls. FDA is taking this action “because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device.”
FDA issued a warning letter to Next Medical Products Company in Branchburg, NJ, for multiple violations of its quality system regulations for its Clear Image Ultrasound Gel for its inadequate environmental controls and failure to establish procedures for implementing corrective and preventive action.
