GlaxoSmithKline scores a win in Zofran case after FDA repeatedly said pregnancy risk data did not require label changes
GSK did sufficiently warn the FDA regarding birth defects tied to its nausea drug Zofran (ondansetron), and because the FDA decided not to update the drug’s label, GSK won a positive decision in a closely-watched case from the US District Court of Massachusetts on Tuesday.
The decision makes clear that GSK and Novartis (the current owner of Zofran as of 2015) informed the FDA of the available data on the safety of Zofran, but from about 2010 until earlier this year, the FDA rejected any label changes that would’ve warned that using the drug during pregnancy could cause harm to the fetus. The CDC currently runs a website noting that, “Taking Ondansetron During Pregnancy Does Not Appear to Increase Risk For Birth Defects.”
The more than 400 lawsuits filed in the multi-district case against GSK claimed that the company withheld crucial data that would’ve pushed the FDA to allow the label updates on Zofran.
But Judge F. Dennis Saylor made clear in his decision, “In short, even assuming that GSK did, in fact, fail to make complete disclosures to the FDA in 1991 [when Zofran’s initial approval occurred], and at various later points, there is no question that the FDA is now fully informed of all relevant information concerning the safety of the drug. And the FDA has made the determination that a label change is not warranted.”
“Thus, the FDA, acting pursuant to the duty imposed on it by federal law, has rejected the pregnancy warning label that plaintiffs insist was required by state law at the time of the alleged injuries. Accordingly, and for the following reasons, plaintiffs’ state-law claims of failure to warn are preempted by federal law,” he wrote.
GSK said in an emailed statement that it is pleased with the judge’s ruling in the company’s favor, noting the court found that the FDA was fully informed about the safety profile of Zofran when it declined to add warnings to its label.
The decision may offer further clarity on whether the FDA’s labeling decisions preempt state law, which has been a battle for the biopharma industry for years.