[1]thx to sammynetbook on flickr creative commons
It’s not every day that the Food and Drug Administration removes a warning letter [2] from its web site. But the agency did just that recently when it pulled down a missive that was originally sent last year to Pacira Pharmaceuticals. And the removal comes just as a closely watched legal battle – which, in part, turns on First Amendment rights – heats up between the drug maker and the agency.
Indeed, as unusual as it is for the FDA to remove a letter, what makes this still more interesting is that it occurs amid a lawsuit Pacira filed recently accusing the FDA of overstepping its authority to thwart inappropriate marketing.
Drug makers, you may recall, must prove their medicines work to treat a specific disease before marketing them for that purpose. As a result, the agency has the right to prevent them from promoting drugs for unapproved uses. But the pharmaceutical industry increasingly complains the FDA unfairly squelches free speech in the name of protecting public health. Pacira is only the latest to vent.
Perhaps not coincidentally, the Pacira lawsuit [3] was filed shortly after another drug maker won a preliminary ruling [4] in a First Amendment case. Last August, a federal judge decided Amarin could promote the benefits of a prescription pill, so long as the info given doctors is not false or misleading.
The issue has been widely debated after a federal appeals court in 2012 overturned a criminal conviction of a Jazz Pharmaceutical sales rep for promoting off-label uses. The court ruled his speech was protected, since the information that was conveyed to doctors was truthful and not misleading.
As for the Pacira warning letter, which was issued on Sept. 22, 2014, the FDA scolded the drug maker for allegedly promoting its Exparel painkiller for unapproved uses and overstating efficacy. The medicine is used following surgery.
The removal surprised FDA watchers.
“It is unusual,” said Patti Zettler, a former FDA associate chief counsel who is now a Georgia State University College of Law professor. But she he noted the FDA is free to remove warning letters. An agency spokeswoman declined comment, citing pending litigation. Perhaps we will learn more next week when the FDA is due to file court papers in its fight with Pacira.
But what does the letter say and why might it be important?
We still have a copy, which you can read here [2], and it goes to the heart of this simmering dispute. The FDA clearly states the Pacira drug should only be used after surgery for just two specific procedures – removing bunions and hemorrhoids. But the agency accused Pacira of distributing promotional material suggesting the medicine is useful after other types of surgery, too.
The FDA further charged that Pacira wrongfully claimed its injectable drug could relieve pain for up to 72 hours after surgery, when clinical trials results demonstrated the drug could relieve pain for no more than 24 hours, according to the letter. In summing up its view, the agency wrote that the “violations were extremely concerning from a public health perspective.”
The US Department of Justice followed up last spring by issuing a subpoena to Pacira for “a broad range of documents” related to the marketing and promotion of the pain medication.
Last month, however, Pacira fired back.
The drug maker filed its lawsuit accusing the agency of retroactively revising the product labeling. The drug maker points to wording saying Exparel is “indicated for administration into the surgical site to produce” post-surgical relief. The drug maker claims this applies to other surgeries and also argues that pivotal studies allow it to extrapolate use for more than bunions and hemorrhoids.
But there was more. As far as Pacira was concerned, the FDA triggered a larger issue – by illegally restricting its ability to market Exparel for other surgeries, the agency violated its First Amendment rights to distribute “truthful and non-misleading” information about the medicine.
To what extent the removal has an impact on the legal battle is uncertain. Meanwhile, under the auspices of the Medical Information Working Group, 11 drug makers signaled in a court filing they plan to submit a brief supporting Pacira. Earlier this year, the FDA indicated a new guidance would be issued and a meeting held to review the topic, but an agency spokeswoman told us a date has not been set.
In any event, the removal does raise the possibility that other warning letters could disappear in the face of litigation. So remember to save them or, if you’re old fashioned, make copies.