Drugs

Split Ruling in Prepopik Exclusivity Case

The DC federal court has rejected part of a Ferring Pharmaceuticals challenge to FDA over an exclusivity period for its Prepopik fixed-dose combination drug. It also asked both sides for further briefing on another aspect of the challenge. Ferring sought a five-year exclusivity for the drug because one of its three component drug substances, sodium picosulfate, had never previously been approved in a NDA.

The agency initially rejected Ferring’s exclusivity request because two of the three substances had previously been approved for market. The company filed a citizen petition challenging the interpretation and FDA found that the exclusivity provision could reasonably be read to refer to “drug substances” and said it would permit five-year exclusivity for fixed-combination drug products that contained a novel drug substance. However, FDA said it would only apply the new interpretation going forward and thus Ferring still was denied exclusivity.

Ferring sued FDA under the Administrative Procedure Act, claiming that the agency’s initial interpretation was contrary to the plain language of the Federal Food, Drug, and Cosmetic Act or an unreasonable interpretation of statutory ambiguity. The court granted FDA summary judgment on this part of the suit, saying that FDA’s initial interpretation was not unreasonable.

Because both sides provided few legal citations supporting their position on the retroactivity question, the court denied both sides’ motions for summary judgment on that question and called for renewed motions for summary judgment on the retroactivity issue.

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