FDA Policy/General

Petition Seeks Ban on Antibiotics in Livestock/Poultry

Several public health groups have petitioned FDA asking that it withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes. Antibiotic sales to the livestock industry have grown in recent years, despite the agency’s request for the industry to voluntarily reduce use, says one of the petitioners, the Natural Resources Defense Council (NRDC). The petition argues that FDA’s voluntary policy shows no signs it will work and therefore the agency needs to eliminate the riskiest uses of antibiotics that threaten human health.

In 2011, an NRDC lawsuit sought the withdrawal of certain antibiotic uses in livestock. The group says the Second Circuit Court of Appeals allowed FDA to pursue a voluntary program in 2013 to curb the antibiotic overuse. “According to FDA’s own data, the voluntary program, known as Guidance 213, is not working,” the group says. “The signals to the industry seem to have had no effect, with antibiotic use continuing to rise since the program’s launch. Indeed, the data suggest that increases in antibiotic use are outpacing increases in livestock production, and that, on average, producers are using more drugs per animal than they did just a few years ago.”

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