The OPDP charged Cipher Pharmaceuticals with failing to include significant risk information for Conzip in a detail aid.
This story has been updated.
The FDA’s Office of Prescription Drug Promotion sent its second enforcement letter of 2017 on Wednesday, flagging Canadian drugmaker Cipher Pharmaceuticals over its promotion of opioid drug Conzip.
The agency’s warning letter to Cipher charged the drugmaker with failing to include significant risk information for Conzip in a detail aid. As a result, the agency said the aid is false and misleading.
Cipher commented on the warning letter Thursday saying that it licensed its U.S. marketing duties for Conzip to Vertical Pharmaceuticals and that it is working with Vertical to address the FDA’s concerns.
The first enforcement letter of 2016 was an untitled letter to Orexigen for its weight-loss drug Contrave, which alleged a failure to disclose certain risk information.
OPDP has issued significantly fewer warning letters in 2017 than it did in recent years. In 2016, the agency issued 11 enforcement letters, compared to nine each in 2014 and 2015.
John Kamp, executive director of the Coalition for Healthcare Communications, said in an emailed statement that “enforcement often lags in a new administration as the new leaders reassess priorities.” He added that the most recent letter to Cipher was indicative of FDA commissioner Scott Gottlieb’s priority to address the opioid crisis.