- Glossing over risk information has landed a small drugmaker in hot water with the Food and Drug Administration's Office of Prescription Drug Promotion, which issued a rare warning letter to Cipher Pharmaceuticals Inc. for misbranding an opioid painkiller.
- In an August letter, OPDP flagged a detail aid for Cipher's opioid agonist ConZip for failing to communicate any risk information about the drug, thereby creating a "misleading impression about the drug's safety." The regulator noted this omission was made more serious by the ongoing opioid overdose epidemic.
- The FDA demanded Cipher, which licenses the drug to Vertical Pharmaceuticals LLC for sale in the U.S., discontinue use of the misbranded promotional materials and detail its plans for issuing corrective messages.
The FDA's OPDP, which regulates how prescription drug companies advertise their products, has been a lot less active in recent years.
After sending 11 warning letters last year, the OPDP has so far issued only two in 2017. That would continue a years-long trend of declining activity since 51 letters were sent to drugmakers in 2010.
Last year's total of 11 was boosted by a flurry of six letters that came in the month of December, so 2017 could still stand a chance of matching 2016.
The steady drop in warning letters to industry could also reflect a change in focus for the regulator.
"OPDP appears to be picking its battles carefully when it comes to enforcement letters, focusing on omission and minimization of risk (a cornerstone of FDA’s enforcement activity in this area) as well as pre-approval promotion," writes Dara Katcher Levy, a director at the law firm Hyman, Phelps & McNamara, in a January post on the closely watched FDA Law Blog.
This was clearly the case with Vertical Pharmaceuticals, which neglected to make mention of any of the risk information associated with Cipher's drug.
Not only did Vertical leave out limitation-of-use restrictions, but the licensee also dropped part of ConZip's indication.
The OPDP requested Cipher respond in writing by September 8 and detail its plans for corrective action.