OPDP Issues Warning Letter for Omission of Risks, Material Facts

Sept. 8, 2017 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued only two enforcement letters this year, its Aug. 24 Warning Letter to Cipher Pharmaceuticals followed a clear pattern: pursuing alleged omission of risk and omission of material facts.

The letter to Cipher (ConZip Warning Letter), which licenses its ConZip® opioid painkiller to Vertical Pharmaceuticals, states that a detail sales aid “makes representations and/or suggestions about the efficacy of ConZip” that include the phrasing “all-day pain relief” and “measures up,” and states the product is indicated “for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.”

OPDP takes issue with these statements because the detail aid “fails to communicate any risk information about the product,” which include boxed warnings regarding addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, interactions with drugs affecting cytochrome P450 isoenzymes, and risks of concomitant use with benzodiazepines or other CNS depressants.

“It’s not unusual for enforcement actions by agencies to drop early in a new administration as the new leaders access priorities,” said Coalition for Healthcare Communication Executive Director John Kamp. “But, taking the facts as presented by FDA, this is a clear violation of rules. And, it relates to opioids, a clear focus of all health policymakers, including Commissioner Gottlieb.”

The sales aid also fails to provide material information regarding ConZip’s full FDA-approved indication, including important limitations of use, according to the Warning Letter.

“By omitting the risks associated with ConZip, including serious ad potentially fatal risks, the detail aid fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” OPDP stated in the letter.

OPDP requested that Cipher immediately cease misbranding ConZip and asked for a response by Sept. 8.