Drugs

Physician Group Sues FDA for Hydroxychloroquine Access

The Association of American Physicians and Surgeons has filed suit against FDA in western Michigan federal court to force the agency to stop limiting access to hydroxychloroquine, a drug touted by president Trump, for prophylactic use against Covid-19. The conservative nonprofit group’s complaint alleges that the agency is “irrationally” interfering with doctors’ and patients’ access to the Strategic National Stockpile’s supply of the antimalarial drug. FDA officials should have made the drug widely available for prophylactic or preventative uses, the complaint says.

Hydroxychloroquine is approved for treating malaria, lupus, and rheumatoid arthritis. In March, the agency issued an emergency use authorization that allows health-care providers to use hydroxychloroquine within certain limitations to treat Covid-19 patients. In April, FDA issued a drug safety communication warning that hydroxychloroquine shouldn’t be used outside of clinical trials as a treatment for Covid-19. The agency said it was aware of reports of serious heart problems in Covid-19 patients, and that it has not been found effective for the new use.

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