Drugs

SCOTUS Wants Government’s View on Fosamax Case

The Supreme Court has invited the Solicitor General to submit a brief outlining the views of the United States on Merck’s request that the high court hear its appeal of a 3^rd Circuit court decision involving a state law failure-to-warn claim for the company’s Fosamax (alendronate sodium). In the case decided by the 3^rd Circuit, consumers brought separate product liability cases against Merck, claiming it failed to add an adequate warning of risk of atypical femur fractures to the FDA-approved label for the osteoporosis drug. A New Jersey federal judge heard the consolidated suits and entered summary judgment for Merck, which the plaintiffs appealed to the 3^rd Circuit.

The appeals court vacated the lower court ruling and remanded the case, saying that the question of whether FDA would have rejected a proposed drug label change is a question of fact for a jury to decide.

Merck’s appeal to the Supreme Court says it is “undisputed” that FDA was aware of the possible link between the drug and the risk at issue and rejected Merck’s comprehensive safety update, saying the “conflicting nature of the literature did not provide a clear path forward” and that it needed more time to consider the issue of a precaution. FDA only became confident that an association potentially existed after it received a report from a task force, Merck says. The appeal frames the question for the Supreme Court as: Is a state law failure to warn claim preempted when FDA rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or must such a case go to a jury for conjecture as to why FDA rejected the proposed warning?

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