Drugs

FDA Wins Pradaxa Application Date Case

The DC federal court has granted FDA summary judgment in a case brought by Boehringer Ingelheim involving a dispute over the agency’s interpretation of the legal reference to the date that a drug application is initially submitted for an approved drug product. The company brought suit to resolve the dispute with FDA over its Pradaxa.

The court noted that the underlying facts of the case are complex and the related science even more so. On the narrow legal issue, it said, BI contended that the agency’s action violated the law and its own regulations and that FDA acted arbitrarily and capriciously because its actions were inconsistent with prior agency practice. FDA argued that its interpretation of the law should be given deference and was reasonable and consistent with the language of the law and not arbitrary or capricious.

BI said that the Pradaxa application should be seen as submitted on 12/15/09 rather than on 4/19/10 as the agency determined. But the court found that the agency interpretation of the legal language is due deference, that the interpretation was reasonable, that FDA reasonably applied its interpretation, and that FDA did not act arbitrarily or capriciously. It thus dismissed the case in its entirety.

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