FDA Policy/General

Animal Rights Group Wins Appeal in FDA Case

The Animal Legal Defense Fund (ALDF) is claiming victory in a 9^th Circuit Court of Appeals decision that sent an ALDF case against FDA involving factory egg farm statistics back to a lower federal court for trial. A full panel of appeals court judges set precedent, ALDA says, by providing less deference to district courts that resolve Freedom of Information Act (FOIA) cases on summary judgment without trial.

The case involves ALDF’s FOIA request for information about hen population and living conditions that the agency collects from large factory farms. FDA records the requested information during inspections of factory egg farms as required by the 2009 Egg Safety Rule, ALDF says. A California federal district court had ruled in 2013 that FDA could withhold most of the information. A three-judge appeals panel sided with the district court in a ruling earlier this year. The ALDF appeal was re-heard by the full appeals court and as a result of that decision the original three-judge panel sent the case back to the district court for trial.

ALDF says the trial “will decide whether FDA’s release of the information on hen population and living conditions is, as FDA argues, ‘likely to cause competitive harm’ to the factory egg farm facilities, and therefore exempt from disclosure under FOIA.” The group says that the factory farm practice of confining hens in small battery cages causes unsanitary conditions and an increased risk of diseases such as salmonella and bird flu, in addition to severe animal welfare concerns.

“Details of animal welfare and the risk of disease outbreaks that affect human health are too important to remain hidden from the public,” ALDF says.

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