FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny.
The undersigned individuals write in strong support of the Food and Drug Administration’s November 8, 2024, proposed order to remove the oral decongestant phenylephrine as a nasal decongestant active ingredient from OTC Monograph M012. Data provided to the agency and summarized in the FDA’s Briefing Document for the Nonprescription Drug Advisory Committee meeting on September 11-12, 2023, confirm that oral PE is barely absorbed into the bloodstream and that the best conducted clinical trials provide no evidence of efficacy on relevant clinical outcomes.
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Nearly 40 percent of U.S. adults—and 50 percent of those over 65—have prediabetes. Eight out of 10 don’t know it. On the upside, the toolbox for preventing or reversing prediabetes is expanding. Here’s what to know.
In March, the Food and Drug Administration added semaglutide to its drug shortages list. That means the pricey popular prescription drug—sold as Ozempic for type 2 diabetes and Wegovy for weight loss—could be purchased from compounding pharmacies. Here’s what to know about buying any medicines from compounding pharmacies...or from websites you find online.
People who take proton-pump inhibitors (PPIs) like Prilosec, Prevacid, or Nexium were no more likely to die of cancer or cardiovascular, respiratory, or digestive disease over 14 years once researchers excluded those who started PPIs within 6 years of dying (since illness, not PPIs, might have raised their risk).
In May, the Food and Drug Administration approved tirzepatide—which patients inject under their skin weekly—to treat type 2 diabetes, because in clinical trials it cut hemoglobin A1c levels (a long-term measure of blood sugar) even more than taking insulin. The FDA has not yet approved tirzepatide for weight loss. But that may soon happen.
