FDA Policy/General

Ninth Circuit Mulls FOIA Summary Judgment Appeals

The U.S. Court of Appeals for the Ninth Circuit may be re-evaluating how it reviews summary judgments in Freedom of Information Act (FOIA) cases. An 8/3 notice granted an en banc hearing in Animal Legal Defense Fund vs. FDA, but provided no explanation why it was rehearing the lower court decision granting summary judgment in the agency’s favor and confirming its holding that under FOIA Exemption 4 (trade secrets) FDA had properly withheld categories of information requested by the Animal Legal Defense Fund regarding egg-production farms in Texas.

In the earlier appellate decision, a per curiam opinion (pg.14) was included that explained why the circuit should reconsider the standard of review that is applied to summary judgments in FOIA cases. In ordinary cases, appellate judges generally review de novo a district court’s grant of summary judgment. “In FOIA cases, by contrast, we allow the district court to make factual findings, and we review those findings for clear error,” the appellate judges wrote. “That peculiar standard means that a dispute of material fact does not necessarily defeat summary judgment.”

The judges further said they “see no good reason to depart from our traditional standard of review in FOIA cases... We originally adopted our deferential standard of review in reliance on a D.C. Circuit Court’s footnote, without explanation.” The D.C. Circuit and other circuits have since abandoned the FOIA-specific standard of review, and it now applies ordinary summary judgment principles such cases. “We urge our court to take up, en banc, the appropriate standard of review in FOIA cases,” they wrote.

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