Pacira sues for free speech; FDA pulls off-label warning letter

On second thought, Pacira Pharmaceuticals, the FDA might just take it back. As Law360 reports, the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices.

According to the FDA warning letter--now taken down from the agency website--Pacira had claimed that Exparel, its pain drug and lead product, could work for up to three days at a time, though it's only approved for 24-hour pain relief. The Department of Justice followed up on the FDA's warning letter with its own investigation into the company's marketing.

It would seem like a good old-fashioned pharma-government tussle over what companies can and cannot say about their products. But the argument has changed significantly, thanks to a series of court rulings that could open the door for drugmakers to market their products in previously unacceptable--even previously illegal--ways.

In fact, the FDA's move comes a little over a month after Pacira sued the agency, claiming that its marketing enforcement interferes with Pacira's free speech rights. It was the first lawsuit to cite the soon-to-be-infamous Amarin ($AMRN) ruling, in which a federal court backed that company's plans to tout unapproved uses of its cardiovascular drug Vascepa, as long as its claims are truthful.

Amarin's Vascepa promotions wouldn't have run afoul of the FDA's rules in any case, the agency has said. But though that court ruling didn't automatically bless off-label drug marketing, it did create a pathway by which other drugmakers could ask for--and get--permission to promote as-yet-unapproved uses for their products.

The question now is whether the FDA is backing down on Pacira and its Exparel marketing. A group of drugmakers filed an amicus brief in the case last Friday, to shore up Pacira's argument against the FDA's crackdown. An FDA spokeswoman wouldn't comment about why the warning letter disappeared off the website, Law360 says, but the agency is set to formally respond to Pacira's lawsuit Oct. 26.

Meanwhile, the FDA has been suggesting that it might rethink its marketing rules under the 'free speech' argument. In fact, the agency said earlier this year that it would hold a public meeting about the issue this summer, but that meeting hasn't yet happened. Nor has the agency issued any new guidelines about off-label promotion.

- see the Law360 news (reg. req.)