Hims & Hers GLP-1 Super Bowl Ad Sparks Debate On FDA Compliance

Telehealth company Hims & Hers Health is set to air its first Super Bowl ad Sunday (Feb. 9), promoting compounded weight-loss drugs -- sparking allegations from a bipartisan Senate duo, the Pharmaceutical Research and Manufacturers of America (PhRMA) and a public health group that the ad is misleading and goes against the intent of FDA’s prescription drug advertising rules. But the lobbying group for compounders, the Alliance for Pharmacy Compounding, argues the ad complies with FDA rules and asserts that...
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FDA Postpones ‘Healthy’ Definition Event, Cancels Meeting With Canada

FDA events are continuing to be postponed or canceled after the end date of the agency’s originally announced communications pause, including events in late January such as a webinar on FDA’s new “healthy” standard for food products and a meeting with Health Canada on international device standards. The event on the new “healthy” definition was scheduled for Feb. 20 to provide an overview of the final rule and answer questions. “We are postponing this event and will be rescheduling it...
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Stakeholders Cling Onto Trump’s Medicaid ‘Love’ Statement In Bid To Quash GOP Cuts

A coalition of insurers, providers and other groups who care for and represent beneficiaries hope congressional leadership will follow President Donald Trump’s recent pledge to “love and cherish” Medicaid and reject the dramatic, cost-cutting reforms Republicans are exploring to pay for policies in the next legislative package. But experts suggest the president's comments will have little effect on negotiations. “I expect congressional Republicans to do what they can to cut federal Medicaid spending regardless of Trump's love,” Bloomberg Senior Research...
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Inside CMS - 02/13/2025
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Gottlieb: FDA’s CDSS Guidance Could Hamstring AI Integration Into EMRs

Scott Gottlieb -- who led FDA under President Donald Trump’s first administration -- is raising concerns that the agency’s 2022 guidance on clinical decision support software (CDSS) could restrict efforts to directly embed artificial intelligence tools capable of analyzing data to generate clinical insights into electronic medical records. He is calling for a return to CDSS policies from his tenure as FDA commissioner when AI tools within such records were generally not regulated as medical devices. AI within EMRs has...
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Generics Advocates: Tariffs Won’t Bring Drug, API Production Onshore

AMELIA ISLAND, FL -- Tariffs won’t be enough to bring generic drug and active pharmaceutical ingredient (API) manufacturing to the United States, generic advocates said at the Association for Accessible Medicines (AAM) conference this week, despite the Trump administration’s tough trade policy. They argued the low cost of labor abroad and limited capacity in the United States means tariffs won’t shift production onshore, risking increased drug shortages without any growth in the domestic industry. AAM CEO John Murphy has previously...
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PhRMA Points To Key Areas Where Transparency Could Be Hiked In Drug Negotiations

Updated Story After CMS signaled it hopes to improve transparency in the Medicare drug price negotiation program, the Pharmaceutical Research and Manufacturers of America (PhRMA) pointed Inside Health Policy to key areas the brand drug lobby has suggested in past comments where the agency could enhance its transparency efforts. The pharmaceutical lobby group tells IHP transparency could be improved in the agency’s application of the bona fide marketing standard to determine when generic competition is available,...
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FL Judge Cites FDA Role As He Dismisses Novo Compounding Lawsuit

A federal district court said it is FDA’s role, not the states, to regulate compounding as it dismissed a lawsuit filed by Novo Nordisk against compounders of its semaglutide GLP-1 drugs, boosting compounders’ stance that only FDA has the authority to enforce federal drug law. The court said the company didn’t have grounds for the claim compounders violated the state’s unfair trade practices law. It’s the latest defeat for Novo, which along with its fellow GLP-1 manufacturer Eli Lilly has...
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HHS Works To Solve CHCs’ On-Going Payment Issues Following OMB Freeze

Federal payments continue to elude some community health centers, which are consolidating or closing locations as they receive partial or no payments, following the White House Office of Management Budget’s since-paused freeze on federal distributions -- though HHS told Inside Health Policy Thursday (Feb. 6) it is working with the Program Support Center to “help expedite resolution as quickly as possible.” “We understand that some Payment Management System (PMS) users experienced technical issues last week,” a Health Resources &...
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Gottlieb Sees Policymaking Difficulties Ahead For FDA Under Trump

AMELIA ISLAND, FL -- Former FDA Commissioner Scott Gottlieb said the agency faces several major challenges to implementing policy in the second Trump administration, including a new White House requirement to retract 10 regulations or guidance documents for every new one that he said could not only bring new rules to a halt but also stifle use of guidance for deregulatory purposes. He also pointed to potentially increased oversight of FDA from the White House, speaking at an Association for...
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