GlaxoSmithKline Says FDA Rejection of Petition to Review Zofran Pregnancy Data Should Provide Company Liability Protection

With hundreds of families pursuing Zofran lawsuits against GlaxoSmithKline that allege children suffered birth defects following exposure to the anti-nausea drug during pregnancy, the drug maker filed a petition with the FDA that sought a hypothetical opinion about whether the agency would have approved earlier warnings based on old study data. However, the federal regulators are refusing to weigh in.

Each of the claims raise similar allegations, indicating that GlaxoSmithKline should be held liable for failing to warn expecting mothers and the medical community about the potential pregnancy risks with Zofran, which has been commonly prescribed “off-label” for symptoms of morning sickness.

Plaintiffs claim Zofran caused children to suffer cleft palates, cleft lips, atrial septal defects, ventricular septal defects and other congenital malformations.

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GlaxoSmithKline has attempted to defend the lawsuits by arguing that the claims are pre-empted by federal law, maintaining that the FDA would not have allowed the pregnancy warnings that plaintiffs indicate should have been included on the drug label and prescribing information.

In November 2019, the drug maker filed a citizen petition that asked the FDA to review four categories of information about the pregnancy side effects of Zofran. However, the agency rejected the petition in a letter (PDF) submitted on January 15, 2021.

“Your request that FDA review and opine on certain pieces of information to answer a hypothetical question separate and apart from FDA’s ongoing product review would divert scientific staff time away from pending drug applications, drug product safety review, and other work critical to our public health mission and therefore would detract from fulfilling the Agency’s statutory obligations,” according to the response. “In addition, because a request to consider a hypothetical question is not a request to ‘take or refrain from taking’ an administrative action, it is not the appropriate subject of a citizen petition.”

Given the similar questions of fact and law presented in the litigation, cases filed throughout the federal court system are currently centralized before U.S. District Judge Dennis Saylor in the District of Massachusetts, for coordinated pretrial proceedings and a series of early “bellwether” Zofran trials, which were previously scheduled to begin earlier this year, but have been delayed due to the COVID-19 pandemic.

Although the FDA refused to provide a hypothetical opinion in response to the questions posed in the petition, the agency did provide lengthy background information on safety-related labeling for prescription drugs to clarify the expectations for drug makers submission of post-marketing safety data and the FDA’s approach to the review of such information. In addition, the agency pointed out that the current manufacturer of Zofran, Novartis, submitted a labeling supplement to the FDA after the submission of GlaxoSmithKline’s petition, which remains under review.

In a notice to the court (PDF) filed the same day as the FDA’s letter, GlaxoSmithKline argues that the FDA’s rejection of the petition still provides support for their position that an earlier label update would not have been approved.

“The simple truth is that FDA fully knows about [study data and all of the Plaintiffs’ other information] and has made the decision not to warn about birth defects even though the study is readily available to the Agency,” according to the drug maker’s filing, which claims that preemption is required in the cases.

The parties are scheduled to meet with Judge Saylor on Friday, for a status conference that will be held in a remote proceeding due to the continuing COVID-19 pandemic.


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