Drugs

Amarin Planning Synthetic Omega-3 Response

Amarin Pharma says it will respond within weeks to a citizen petition asking FDA to make an exception to the statutory requirements for synthetic omega-3. Amarin says its response will explain that a product with synthetic eicosapentaenoic acid cannot be legally marketed as a dietary supplement because such marketing would be inconsistent with the law. The Amarin statement is in its comment letter responding to an FDA request for input on responsible innovation in dietary supplements.

The company says that synthetic omega-3 does not comply with the structural limitations on dietary supplements in the Dietary Supplement Health and Education Act because (1) it does not qualify as a “dietary ingredient” and (2) it is excluded from the definition of “dietary supplement” by the exclusionary clause.

In its general comment on the topic, Amarin said it is “particularly concerned about dietary supplements that are deceptively marketed in a manner that distracts patients from seeking medical attention and, if appropriate, obtaining treatment with proven drug therapies….”

It called on FDA to take steps to interpret and enforce the definition of “dietary supplement” in the Federal Food, Drug, and Cosmetic Act in a manner that is consistent with Congress’ intent and does not undermine the drug approval provisions and the Waxman-Hatch provisions in the law.

“Enforcing the structural and marketing limitations on dietary supplements will preserve the statutory distinctions between ‘drugs’ and ‘dietary supplements,’” it says. “Failing to preserve these distinctions would be inconsistent with the statute’s structure and design, expose the public to unsafe and/or ineffective products, and create disincentives for drug development and innovation, such that the therapeutic benefit of certain substances may never be realized.”

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