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FDA limits industry roles in advisory committees
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April 18, 2025
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SCOTUS to hear challenge to ACA preventive care rule
US Supreme Court (Win McNamee/Getty Images)
The Supreme Court is set to hear Kennedy v. Braidwood Management, a case that challenges the Affordable Care Act's provision mandating insurers cover certain preventive services at no cost, including cancer screenings and HIV prevention drugs. Health experts fear that striking down the provision could lead to fewer screenings and more advanced disease diagnoses.
Full Story: STAT (4/17),  InsuranceNewsNet Magazine (4/15) 
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The US health care sector faces potential disruptions due to China's export restrictions on rare earth elements used in treatments and diagnostics. The trade tensions elevate concerns about the security of supply chains critical to health care. Among the rare elements being restricted are lutetium and yttrium, used in radiopharmaceuticals for cancer treatment.
Full Story: The Washington Post (4/18) 
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Legislative & Regulatory News
The FDA introduced a new policy to limit the roles of industry employees, such as those from pharmaceutical companies, on its advisory committees. This change, announced by FDA Commissioner Martin Makary, seeks to reduce potential conflicts of interest and promote transparency. The policy allows industry representatives to attend meetings but not serve as official members.
Full Story: Reuters (4/17) 
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The HHS has stopped funding GeoVax's COVID-19 vaccine, GEO-CM04S1, which was supported by Project NextGen. GeoVax will continue developing the vaccine, which has shown promise in trials as a primary and booster shot.
Full Story: BioSpace (4/17) 
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Drug Industry Spotlight
Glenmark Pharmaceuticals is recalling 39 different generic drugs produced at a facility in India that failed to meet manufacturing standards. Recalled drugs include diltiazem hydrochloride, ranolazine, clindamycin hydrochloride, voriconazole, cetirizine hydrochloride, lacosamide and gabapentin.
Full Story: Health (4/17) 
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The FDA has designated Celltrion's Yuflyma as an interchangeable biosimilar to adalimumab, marking it as the fourth biosimilar to receive this status. Yuflyma is indicated for ulcerative colitis and adult Crohn's disease, along with other conditions.
Full Story: Healio (free registration) (4/15) 
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An Employee Benefit Research Institute survey found gaps in enrollees' understanding about health insurance, especially regarding prescription copays and out-of-pocket limits. Data showed about 1 in 4 knew prescription copays were not the same for all groups of prescriptions.
Full Story: FEDweek (4/17) 
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PCMA is the national association representing America’s pharmacy benefit companies. Pharmacy benefit companies are working every day to secure savings, enable better health outcomes, and support access to quality prescription drug coverage for more than 275 million patients. Learn more at www.pcmanet.org

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