The FDA has given up its attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, Exparel. The company wanted a supplement to their label that showed the drug was not limited to a specific surgery.
FDA Gives Up Off-Label Fight With Pacira
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The FDA threatened Pacira with a warning in 2014 over the company’s promotional materials. The agency said those materials violated the off-label promotion prohibition. Exparel is used on the site of a surgery and is marketed as an alternative to opioid pain pills.
The company sued the agency in September citing the First Amendment and Amarin case where a federal court ruled that companies had the constitutional right to speak truthfully about its products.
The agency clearly did not want another loss in a federal court which undermines its diminishing authority to regulate truthful speech.
In a letter to the company on December 14, 2015, the agency waved the white flag and said, “It’s important to note that this resolution is specific to the parties involved in this matter.” Janet Woodcock, the agency’s director of the Center for Drug Evaluation and Research, wrote that after further review, the agency had concluded that the drug’s approval wasn’t limited to the two types of surgeries. The language of the label had “created ambiguity.”
In Amarin, the same court where Pacira filed its suit, ruled the agency couldn’t prohibit Amarin Corp. from talking to physicians about unapproved uses of its fish-oil pill. Physicians are allowed to use devices and drugs off-label but companies have been restricted on talking about off-label uses, unless a physician specifically requested the information. The Amarin ruling allows companies to hand out the information more widely without a request.
As we reported earlier, the FDA has promised to hold public hearings and find a better way to get more truthful and scientific information to the medical community and the public without prohibiting free speech. This surrender in the Pacira case signals that soon there may be a floodgate of demands by companies and physicians to distribute and receive truthful information not found on a company’s original approved label.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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