Drugs

Biosimilars Likely to See No Federal Preemption Protection: Attorney

Biosimilar products are unlikely to have federal preemption protection from state product liability claims like generic drugs under PLIVA v. Mensing, according to an analysis by Reed Smith attorney James Beck. Traditional generic preemption “depends on the impossibility of making an immediate change to a product (including its labeling) as required by state law, where the same change necessitates prior approval by the FDA under federal law,” he says.

A recent FDA guidance on biosimilar labeling of biosimilar products says that when new information becomes available that causes information in labeling to be inaccurate, the application holder must take steps to change the content of its product labeling, in accordance with 21 CFR 601.12, Beck says. He notes that there doesn’t appear to be anything in the biosimilar statute like 21 U.S.C. §355(j)(2)(A)(v), which requires generics to have labeling “the same as the labeling approved for the listed drug.”

Beck concludes that to the “extent of the information encompassed by 21 C.F.R. §601.12(f)(2)(i), it appears that biosimilar manufacturers will be stuck with the same kind of product liability litigation as are their listed counterparts.”

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