New Jersey-based pharmaceutical manufacturer Pacira Pharmaceuticals has been sent a Warning Letter by the US Food and Drug Administration (FDA) after the regulator took issue with the way in which the company was promoting its analgesic drug Exparel.
FDA's letter, dated 22 September 2014, references "educational technique flashcards" and a journal advertisement the agency said created the impression that Exparel has been approved for "new uses for which it lacks approval" and overstates the efficacy of the drug for the purposes for which it has obtained approval.
The Warning Letter is relatively unusual, as FDA most often sends companies so-called "Untitled Letters" for perceived violations of its advertising regulations. The Warning Letter, sent by FDA's Office of Prescription Drug Promotion (OPDP), is one of just a small handful issued by the office since it changed its name from the Division of Drug Marketing, Advertising and Communications (DDMAC), according to FDA records.
"Extremely Concerning"
FDA called Pacira's alleged violations "extremely concerning from a public health perspective."
FDA's concern is largely focused on the expansion of Exparel's claims. The drug has been studied and approved for use as an injectable local anesthetic agent after two specific surgeries: bunionectomy and hemorrhoidectomy.
However, FDA said the company's products indicated the drug had been used in specific surgical settings, such as in a laparoscopic cholecystectomy and an open colectomy. Neither surgical procedure is supported by data provided by Pacira, FDA said. Even disclosures in the company's materials did "not mitigate the overwhelming impression that Exparel is safe and effective for use in cholecystectomy and colectomy," FDA wrote.
FDA also said it was "concerned" about an "array of professionally-directed promotional materials" that implied the drug to be safe and effective in "various other surgical procedures."
"These additional materials suggest an extensive promotional campaign by Pacira to promote the use of Exparel in surgical procedures other than those for which the drug has been shown to be safe and effective," FDA wrote.
Corrective Advertising Ordered…
The letter goes on to also chide Pacira for allegedly implying that Exparel is more effective than it had been able to demonstrate through "substantial evidence" or "substantial clinical experience"—two metrics often used by FDA, and generally taken to mean evidence obtained through Phase III clinical trials. Pacira had claimed through its materials that Exparel controlled pain for up to 72 hours with a single dose."
"Pain control beyond 24 hours … has not been demonstrated," FDA observed.
FDA ordered the company to immediately cease violating federal regulations, and to issue corrective messaging to all affected audiences "for the same duration of time and with the same frequency that the promotional material was disseminated."
… But Company Maintains Innocence
In a statement, Pacira said that it stood behind its claims.
"We take regulatory compliance very seriously and believe that our current labeling supports the claims being challenged by the FDA,” said Dave Stack, president, CEO and chairman of Pacira. The company plans to explain its "position" further to regulators, Stack added.
Warning Letter
Press Release