FDAs

US Court Confirms FDA’s Decision to Ban Compounded Versions of Ozempic and Wegovy

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A federal judge in New York has supported a U.S. Food and Drug Administration decision that prohibits the compounding of alternatives to the diabetes medication Ozempic and its weight-loss counterpart, Wegovy. The ruling comes amid soaring demand for these drugs, which have gained popularity for their effectiveness in managing weight. The case arose when a group of pharmacies sought to produce compounded versions of these medications, which are manufactured by Novo Nordisk. These compounded alternatives would allow pharmacists to create custom formulations for patients, yet the FDA argued that such practices may pose risks of … Read more

Evangelical Lawyer Hilary Perkins Resigns as FDA’s Top Attorney Amid Pressure from Senator Josh Hawley

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WASHINGTON, D.C. – Hilary K. Perkins, the recently appointed top lawyer at the Food and Drug Administration and a known evangelical Christian, has resigned amid escalating pressures from Senator Josh Hawley, who also shares evangelical beliefs. Her resignation follows a series of conflicts rooted in differing interpretations of legal duties and personal faith-related stances on abortion. Perkins, who stepped into the Department of Justice in 2019, expressed the difficulty of her position which involved defending policies under administrations with opposing views on abortion—first under Donald Trump and then under Joe Biden. Such professional obligations led … Read more

Scrutinizing the Downsides of FDA’s Fast-Track Approval: Risks and Legal Battles Unfold

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WASHINGTON — Numerous medical products launched in the U.S. receive clearance through expedited Food and Drug Administration (FDA) processes, which have stirred controversy over their scrutiny of device safety and efficacy. Critics argue these processes are inadequately rigorous, often greenlighting devices too quickly without sufficient evaluation. The 510(k) Premarket Notification, a popular pathway for medical device approval, particularly attracts criticism. It allows devices to be approved based on similarity to previously approved devices without requiring new clinical safety and efficacy studies. Often, this process takes less than a year, raising concerns about the thoroughness of … Read more