Drugs

‘Defense-Friendly’ 5th Circuit Decision for Hospira

Attorney James Beck (Reed, Smith) says the 5th Circuit Court of Appeals issued 5/24 a “defense-friendly” decision in Hickey v. Hospira that reversed in large part a decision by a Louisiana federal court. Beck says the appeals court applied the same implied preemption analysis to Section 355(b)(2) NDA approvals as to any other prescription drug.

He says the appeals court corrected several missteps from the lower court decision by:

agreeing with several other courts in rejecting the plaintiffs’ argument that there was no separate “newly acquired information” preemption prong and that the only relevant question was the “clear evidence” issue under the FDA changes being effected regulation;
agreeing with the defendants that the entire definition of “newly acquired information” was essential to the preemption question, reversing a lower court holding that Beck says ignored FDA’s express requirement that the information for a changes being effected label change not only be new but also had to “reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA”; and
reviewing five items of medical literature, the “cumulative” science, and adverse event reports from one of the defendants and finding that four of the five literature reports and the cumulative science could not constitute newly acquired information as a matter of law on the appellate record because they failed to meet the requirement for demonstrating a different type or greater severity or frequency for the changes being effected regulation to apply.

The court found that an abstract in the medical literature was the only piece that could conceivably qualify as newly acquired information under FDA’s regulations. It sent the case back to the lower court to consider preemption under the correct legal standard as applied to the abstract. It told the lower court that if its analysis finds that the abstract is not sufficient to fully qualify as newly acquired information, “then these defendants are not liable to these particular plaintiffs on their state law failure-to-warn claims.”

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

Read more

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