Another Bullet Aimed at FDA’s Off-Label Powers

The legal Chinese water torture to the FDA’s dying off-label speech power continues. Soon the agency might be afraid to even issue a Warning Letter alleging misbranding.

Sorrell, Caronia and Amerin

First there was Sorrell v U.S. in 2011 where the Supreme Court said speech in the “aid of pharmaceutical marketing” is protected free speech under the First Amendment. Then came Caronia in 2012 when a federal appeals court said the FDA can’t prosecute drug and device manufacturers for making “true” off-label statements. Then this past year, Amerin sued the FDA over the threat of being prosecuted, and the Supreme Court deep-sixed the FDA’s argument that the agency wasn’t prosecuting speech, but “conduct that is evident of intent.”

Pacira and Warning Letter

Now comes Pacira v FDA and a labeling case resulting in a Warning Letter.

Pacira, the maker of Exparel, a surgical pain medication, sued the FDA on September 9, 2015.

The drug, EXPAREL, is indicated for “administration into the surgical site to provide postsurgical analgesia” and the indication does not include any limits in the type of surgeries. ​With the Warning Letter, the FDA was attempted to prevent the company from sharing information about its drug outside of bunionectomies and hemorrhoidectomies, the two types of surgeries that formed the basis of its approval. According to the FDA’s guidance on labeling for analgesic drugs, the results of two studies, one in visceral and the other in non-visceral pain, can be extrapolated to other types of pain.

Back in September 2014, the FDA handed the Pacira a Warning Letter objecting to the company’s promotional materials and accusing the company of a criminal violation. The Warning Letter said that the clinical trial section of the label states the drug “has not been demonstrated to be safe and effective in other procedures.”

The company acquiesced to the FDA’s demands in the Warning Letter while continuing to request a meeting to discuss what it believed to be unlawful restrictions on a broad indication of “administration into the surgical site”.

But, according to a law blog written by Michael Walsh and Katherine McGahey, the FDA stonewalled. “Given the threat of criminal sanctions, the company relented and did what the FDA demanded and refrained from disseminating truthful FDA-approved information to physicians. The FDA subsequently issued a ‘Close Out Letter’ and Pacira continues to refrain from engaging in conduct that the FDA is barred by the First Amendment from prohibiting.”

The lawyers argue that before the regulatory ship sinks entirely, FDA should consider keeping its promise to hold public hearings “and get the reasoned voice of industry, the public, and even the public interest groups to provide guidance on what has become a public health imperative to provide more, not less, truthful scientific and medical information to the medical community and the public concerning approved products.”

No date for trial has been set for Pacira.