Drugs

Court Dismisses Health Science Funding Case vs. FDA

The New Jersey federal court has granted an FDA motion seeking dismissal of a case brought against it by Health Science Funding, which developed and markets as a medical food Prastera, a pharmaceutically pure dehydroepiandrosterone product. The company typically sells Prastera as a dietary supplement for women with lupus. In its suit, Health Science Funding sought a judicial opinion that Prastera meets the legal definition of a medical food and an injunction to prevent the agency from taking any enforcement action against it during the litigation once Prastera is recognized by the court as a medical food.

The court held that FDA has not taken any final action regarding Prastera’s status as a medical food and no enforcement action, and thus there is no dispute that is ripe for judicial review. The court cannot become involved, it said, until FDA has in fact taken final actions that harm the company.

The court also found that the company lacked standing to seek an injunction against the agency because any injury it has suffered is not subject to judicial review. It held that the company was attempting to circumvent FDA’s ability to use its administrative enforcement tools.

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