Drugs

Lawsuit Against FDA and Livestock/Poultry Antibiotic Use

Several public health advocacy groups have filed a lawsuit against FDA that challenges a 2021 denial of a citizen petition that sought the withdrawal of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes. The petition included FDA’s own assessment that the antibiotics used in livestock and poultry are contributing to the development of antibiotic-resistant bacteria that can be transferred to humans, according to the lawsuit.

It alleges that about two-thirds of medically important antibiotics sold in the U.S. (e.g., penicillins and tetracyclines) are also sold for use in food-producing animals. “These antibiotics are often administered to entire herds or flocks in feed or water, to prevent infections that tend to occur when animals are kept in cramped, unsanitary conditions common in factory farms,” it says.

The groups also contend that more than 2.8 million antibiotic-resistant infections occur in the U.S. annually. “These difficult-to-treat infections contribute to as many as 162,000 deaths annually,” they say in the lawsuit. “The antibiotic resistance crisis is fueled in significant part by the misuse and overuse of antibiotics in industrial livestock and poultry production.”

Filed in the Southern Maryland federal court by the Alliance of Nurses for Healthy Environments, Food Animal Concerns Trust, Natural Resources Defense Council, and Public Citizen, the lawsuit claims FDA violated the Administrative Procedure Act when it denied the petition. It is seeking a court order granting the petition or directing FDA to review anew the petition.

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