3:23 PM
 | 
Jan 11, 2019
 |  BioCentury  |  Politics, Policy & Law

Supreme Court may reset FDA-State power balance

How the Supreme Court may reset FDA preemption power

Following oral arguments in Merck v. Albrecht on Jan. 7, the Supreme Court is pondering a decision that could reset the balance of power over drug label warnings between FDA and state courts. The outcome could have substantial financial implications for drug companies, either limiting or increasing their vulnerability to state tort litigation.

The court is being asked to decide if FDA’s denial of a proposed warning from Merck & Co. Inc. about a specific type of risk precluded the company from warning about a different risk.

More fundamentally, the case is about the roles of state courts and FDA in protecting the public from inaccurate or missing warnings on drug labels, and the Supreme Court is being asked to tell lower courts how they should determine if an FDA labeling decision preempts state law.

The underlying question is whether litigation in state courts supplements FDA vigilance, or if on the contrary, it undermines the agency’s authority and endangers public health by substituting an unpredictable hodgepodge of state court rulings for the judgment of a federal regulatory agency.

The comments and questions of Supreme Court justices outlined the contours of the controversy, but as always it is impossible to make confident predictions of their ruling based on oral arguments.

“This question has arisen repeatedly in lawsuits brought against PhRMA’s members and has perplexed the lower courts.”

PhRMA

Caution about predicting the outcome is especially justified in Merck v. Albrecht, because the case is the direct result of controversies about the application of a prior Supreme Court case, Wyeth v. Levine. In that case, which established that manufacturers and not FDA bear legal responsibility for warnings on drug labels, many pharma lawyers incorrectly assumed after sharp questioning in oral arguments that Wyeth would prevail.

A developing safety signal

The Merck v. Albrecht story started in June 2008, when FDA requested that Merck & Co. Inc. submit data about a “developing safety signal” related to a possible association between the company’s osteoporosis drug Fosamax alendronate and bone fractures.

Merck submitted adverse event data to FDA, and in September 2008 applied to add language to the Fosamax label about increased risk of bone fractures. The company requested to add information about “atypical and subtrochanteric fractures” in the Adverse Reactions section of the label, and information about “low-energy femoral shaft fracture” in the Warnings and Precautions section.

FDA responded in May 2009 with a complete response letter approving the Adverse Reactions addition and denying Merck’s...

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