Drugs

Court Reaffirms Buckman ‘Private Suit’ Ruling

A Federal Circuit Appeals Court ruling in Amarin v. ITC has reaffirmed the Supreme Court’s Buckman decision that only the federal government, and not private litigants, can bring suit for noncompliance with medical device requirements. Attorneys James Beck (ReedSmith) writes online in the Drug & Device Law blog the Amarin suit asserted Lanham Act claims that products competing with its Vascepa and containing the same active ingredient were “deceptively” labeled and advertised as “dietary supplements” when they really were illegal new drugs that had never received proper FDA approval. Its case was filed with the International Trade Commission (ITC) as a Tariff Act violation, seeking to bar importation of the supplements.

FDA called the Buckman decision to the ITC’s attention and the ITC agreed with FDA and declined to open an investigation. Beck says the decision means that “private Federal Food, Drug, and Cosmetic Act enforcement, whether under the Lanham Act or anywhere else, took it on the chin. As a matter of law, a complaint about FDA’s failure to act could not be ‘unfair competition’ under either the Tariff Act, Lanham Act, or seemingly anything else.”

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