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Wednesday
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17 September, 2025 |
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Ousted CDC Director Susan Monarez testified before the Senate HELP Committee today, offering another sign that RFK Jr. is facing more heat from fellow Republicans as his revamped ACIP meets Thursday and Friday. While the committee has set an agenda to vote on changes to CDC recommendations for MMR, Hepatitis B and Covid-19 vaccines, the largest association of US health insurers said Tuesday they will continue to cover all ACIP-recommended vaccines that were recommended as of the beginning of this month. |
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Zachary Brennan |
Senior Editor, Endpoints News
@ZacharyBrennan
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FDA Commissioner Marty Makary (Drew Angerer/AFP via Getty Images) |
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by Zachary Brennan
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The FDA on Tuesday released 40 letters sent to companies as part of its crackdown on pharmaceutical ads, revealing some of its criticisms on how risks and benefits of drugs are presented. The untitled
letters concentrated mostly on television ads from Pfizer, Novartis, Bristol Myers Squibb, AbbVie, Alnylam, Boehringer Ingelheim, Sanofi, AstraZeneca and others. Several companies received multiple letters each. Bristol Myers, for example, received three untitled letters for "false or misleading" TV ads related to their blockbuster cancer drug Opdivo and their cardiomyopathy drug Camzyos. In the letter, the agency took issue with the safety explanations in each, among other concerns. |
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by Ngai Yeung
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The FDA issued warning letters to telehealth companies for making "false or misleading" claims about compounded GLP-1 obesity drugs. The letters were part of a larger group of warnings posted on Tuesday that were sent to online pharmacies, pharmaceutical giants, telehealth startups and other companies as part of the Trump
administration's clampdown on drug advertising. Among the telehealth companies that received letters were Hims & Hers and Remedy Meds, which bought fellow digital health platform Thirty Madison for $500 million. Both sell compounded versions of popular weight loss drugs. While these compounded drugs are not approved by the FDA, they surged in popularity over the past few years during the nationwide
shortage of GLP-1 drugs. Some telehealth companies capitalized on the demand, building entire businesses around the alternative versions. |
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by Zachary Brennan
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For years, the end of every pharmaceutical ad has been a well-worn convention: After smiling patients are done walking down the beach, or singing while walking down the beach, a voice reads a summary of side effects and risks that may come with treatment. Under the FDA, those brief warnings have been a compromise between regulator and industry, trying to strike a
balance between what people will pay attention to during a brief break in their show or game, and a complete picture of the complex set of trade-offs that comes with many medications. This week's announcement by the FDA that it plans to upend that policy on side effects could completely change — or dismantle — that convention, and potentially drug advertising as a whole. |
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CDER Director George Tidmarsh (FDA via YouTube) |
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by Zachary Brennan
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The FDA's top drug regulator denied a report that said he might "abandon" certain advisory committee meetings that often review controversial drug candidates before potential approval. Center for Drug Evaluation and Research Director George Tidmarsh said earlier this week that the agency “would like to get away” from
assembling its outside expert panels to examine and vote on individual drugs because “I don’t think they’re needed," according to a KFF Health News story published Friday. The report said FDA leaders seek to "abandon" these expert reviews. When asked if he would abandon or eliminate adcomms that focus on individual drug applications, Tidmarsh denied it, telling Endpoints News, "Abandon? I have
never said that." Tidmarsh did not respond to a request for more clarity on his views around adcomms. |
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by Max Bayer
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Covid-19 shot makers have not been working closely with the CDC’s vaccine advisors and aren’t expected to make substantive presentations to the panel when it convenes later this week, multiple sources familiar with the planning told Endpoints News. The CDC's Advisory Committee on Immunization Practices is scheduled to
meet starting Thursday to discuss and vote on recommendations for hepatitis B, MMRV and Covid-19 vaccines. Sources told Endpoints that an agenda item for Friday, listed as “COVID-19 Vaccine Manufacturer updates,” will be an opportunity for the companies to respond to earlier presentations made during the meeting. Companies have historically been allotted time during ACIP meetings to give detailed presentations on updated vaccine
data. |
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HHS Secretary Robert F. Kennedy, Jr. (George Walker IV/AP Images) |
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