Just as a federal judge says it's time to close the books on the Chantix litigation that's been moving through her Alabama court, Pfizer ($PFE) is preparing for another kind of fight over the drug. The company has been building its case for the FDA to clear the black-box warning off the stop-smoking drug's label, but patient groups are now petitioning the agency to add more heft to that warning instead.
According to the Associated Press, five patient advocacy groups petitioned the FDA Wednesday, asking the agency to deny Pfizer's bid to remove the black box, which warns of potential psychiatric side effects, including depression, hostility and suicidal thoughts. The groups urge the FDA to add warnings about potential blackouts and seizures to the list.
And they want the label to say that pilots, air traffic controllers and military personnel shouldn't take the drug, pointing out that the Federal Aviation Administration and Department of Defense already restrict it.
Meanwhile, Pfizer has been touting data from its own studies, including one that suggests people with depression can use Chantix to quit smoking without an increase in adverse psychiatric effects, compared with Chantix users who weren't depressed when they started therapy.
This is all a build-up to next week's FDA advisory panel meeting, where they agency's expert advisers can weigh in on Chantix's safety and warnings. According to the committee agenda, the group will look at data from observational studies and a meta-analysis of controlled trials conducted after the original side-effects reports emerged.
If Pfizer succeeds in persuading the panel--and the agency--to pull the black box, that would close a chapter in the drug's controversial history. Another bit of closure is coming in Alabama, where Judge Inge Johnson held a final status conference in the litigation over Chantix and its links with suicide.
The judge's order is a standard wrap-up in the sort of multi-district litigation that was assigned to her court. It follows the settlement of 2,900 lawsuits for around $300 million, the Alabama news site AL.com reports. (She does leave the door open to new Chantix-related work, though, saying she would "welcome the transfer of any such action to this court for further proceedings, given the court's experience with these claims.")
The judge pointed out that her "court oversaw extensive discovery, including the production of over 22 million pages of documents, dozens of depositions, and voluminous written discovery." Expert witnesses in the litigation, in fact, tried to have some documents unsealed for presentation to the FDA advisory committee, but that request was denied.
- read the AL.com story
- get the Associated Press news
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