Drugs

FDA Settles Ivermectin Messaging Lawsuit

FDA has agreed to settle a lawsuit brought by three physicians who objected to the agency’s messaging during the Covid-19 pandemic that consumers should stop taking ivermectin because it was for treating horses. A court had earlier ruled (see earlier story) that when the agency issued its “You Are Not a Horse” and similar messaging to caution people not to use the veterinary drug ivermectin to treat Covid-19, it did not mention there is a human version of the drug. The doctors who filed the suit said they had prescribed the human form of the drug to thousands of their patients and the FDA messaging interfered with their individual medical practice. The doctors argued that the messages violated the FDA enabling act and the Administrative Procedure Act.

In its earlier ruling, the 5th Circuit court of appeals said FDA “can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” Thus, it says, the doctors can use the APA to assert their ultra vires claims against the defendants. “FDA is not a physician,” the appeals court decision concluded. “It has authority to inform, announce, and apprise, but not to endorse, denounce, or advise.”

Under the settlement, FDA has agreed to retire a Consumer Update entitled, Why You Should Not Use Ivermectin to Treat or Prevent Covid-19 that was originally posted on 3/5/2021. It also agreed to delete and not republish social media posts from 2021 that read: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome