On December 15, 2015, Pacira Pharmaceuticals Inc. (PCRX), a major player in the drug industry, announced that the US Food & Drug Administration (FDA) had withdrawn its accusations that the company had engaged in unlawful “off-label” promotion of its non-opioid pain drug, Exparel, by promoting the drug for uses other than two particular uses studied in PCRX’s clinical trials. Touted by many as a groundbreaking settlement for the pharmaceutical industry partaking in off-label marketing of drugs, a practice whereby the industry would market medications that are being used in a manner not specificed in the FDA’s approved packaging lable or insert, the FDA rescinded its Warning Letter to PCRX and publicly renounced the regulatory position on which the Warning Letter was primarily based.
In its Warning Letter to PCRX, dated September 22, 2014, the FDA alleged that the company’s promotion of Exparel for use as a post-surgical numbing pain medication outside of the scope of the two types of surgeries described in its clinical trial, constituted unlawful off-label promotion. The FDA posited that PCRX’s distribution of administration guides that described individual physicians’ experiences administering Exparel into the sites of laproscopic cholecystectomy and open colectomy procedures, among others, fell outside of the scope of the drug’s label, and was therefore, prohibited. The Warning Letter also stated that PCRX’s advertising claims that Exparel provides “pain control that lasts up to 72 hours” were misleading and overstating the drug’s efficacy.
PCRX filed a lawsuit against the FDA and its counsel, making the argument that the FDA had effectively attempted to narrow the approved indications of the drug; that the FDA’s actions exceeded the authority that Congress granted the agency under the Federal Food, Drug, and Cosmetics Act (FDCA); and that the FDA’s parallel implementing regulations represented an “unlawful, retroactive revision of the drug’s original broad approval.” As a result of the settlement, the FDA, conceded to PCRX’s claims that the FDA had inappropriately narrowed the scope of the drug’s label in that the uses were never, in fact, limited to the particular procedures.
Pharmacy providers and drug manufacturers should be aware that the settlement marks a monumental victory for the drug industry in that it effectively chips away at the restrictions on off-label marketing of drugs by demonstrating not only that the FDA is not bulletproof, but that changes in the way the FDA enforces off-label marketing are underway. In fact, the Center for Drug Evaluation and Research (CDER) has included in its priorities for 2016, as a “front burner priority”, the mission to “re-evaluate FDA’s regulation of drug advertising and promotion in light of current jurisprudence around the First Amendment.”
Frier Levitt can assist pharmacy providers and drug manufacturers in navigating the complex and changing environment surrounding the marketing of drug products by ensuring that marketing efforts comply with relevant federal laws, FDA regulations, and paralleling state laws. Contact us today to speak to an attorney.
