Drugs

Supremes Seem to Tilt to Merck in Fosamax Case

U.S. Supreme Court justices 1/7 appeared to be leaning in Merck’s favor in its arguments for reversing a 3^rd Circuit Court of Appeals ruling that allowed hundreds of state-based liability claims involving alleged failure to adequately warn of fracture risk associated with Fosamax (alendronate sodium) to go to trial. In 2008 Merck gave FDA data suggesting that Fosamax might be linked to certain bone fractures, but the agency rejected the company’s proposal to add a Warning to the labeling. FDA reversed that decision in 2010 after reviewing new research and ordered the company to add the Warning. But more than 500 patients said their injuries occurred before 2010 and Merck should have warned them sooner.

The company says the FDA 2008 rejection of a labeling change should preempt the suits. A New Jersey federal court agreed with Merck, but was overturned by the 3^rd Circuit, which said that a “reasonable jury” could conclude that FDA had objected only to Merck’s wording of the proposed labeling change and might have approved a properly worded Warning.

In oral arguments before the high court, some conservative justices as well as liberal Justice Stephen Breyer noted that FDA had been uncertain about the fracture risk and rejected Merck’s proposal to add a warning label to the drug’s label, Reuters reported. The justices appeared skeptical of plaintiffs’ arguments and stressed the need to be cautious about warnings on drugs. Over-warning, Breyer suggested, can hurt the majority of patients “who can benefit from this medicine,” Reuters said. Liberal justices Elena Kagan and Sonia Sotomayor said Merck had a duty to present proper data and relevant warning labels to FDA instead of letting the agency figure out what to do. “Seems to be sort of turning responsibility on its head,” Sotomayor said.

To view a transcript of the oral arguments, click here.

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