First 2018 OPDP Enforcement Letter Targets Exhibit Booth for Opioid

Feb. 23, 2018 – Companies, especially those that make opioid products, should make sure that promotional material displayed at conference exhibit booths clearly communicate their products’ risks and limitations of use, and that they heed advisory comments from the Office of Prescription Drug Promotion (OPDP), which issued an Untitled Letter to Collegium Pharmaceutical Inc. on Feb. 9.

The first OPDP enforcement letter of 2018 states that a Collegium exhibit booth at the American Society Health-System Pharmacists Summer Meetings & Exhibition 2017, held in Minneapolis June 3-7, 2017, made false or misleading representations “because it fails to adequately communicate information about the serious risks associated with XTAMPZA ER™” (oxycodone) extended-release capsules for oral use.

Xtampza ER is indicated for the management of “pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” Because of significant risks, such as the risks of addiction, abuse and misuse with opioids, there are limitations of use stated in the prescribing information (PI) of the product. The PI for Xtampza ER contains a boxed warning, contraindications and warnings and precautions about the drug.

OPDP states in the Feb. 9 Untitled Letter that it had prior communications with Collegium on Sept. 9, 2016, addressing draft presentations for Xtampza ER, in which OPDP recommended that Collegium revise proposed presentations that had “certain similarities to the exhibit booth in this letter.” OPDP advised changes to the materials so they did not: misrepresent the approved indication or omit other material important context; misrepresent or omit important risk information; or omit other material information.

“In particular, we cautioned Collegium about failing to present risk information for Xtampza ER with a prominence and readability reasonably comparable to the presentation of benefits,” the enforcement letter states. “We are concerned that Collegium is promoting Xtampza ER in a manner that fails to adequately present the very serious risks of the drug, despite this direction from OPDP.”

Specifically, the exhibit booth featured a principal display panel that prominently presented benefit claims about the abuse-deterrent properties of Xtampza ER, but failed to include any information about the drug’s limitations of use, nor did the display panel include any information with respect to serious risks included in the boxed warning.

Although OPDP notes that the exhibit booth did have a side panel that included risk information, that panel was located several feet away from the main panel and used a different colored background and smaller font size than the main panel, “without any visual elements linking it to the principal display panel.” Further, information about possible abuse of the drug was displayed near the floor and was “obscured by a table and chair,” thus rendering the information as “not visible to viewers as a practical matter.”

OPDP contends in the Untitled Letter that the exhibit booth made “representations and/or suggestions about Xtampza ER but failed to adequately provide material information about the drug’s limitations of use and the serious and life-threatening consequences that may result from the use of the drug, thereby creating a misleading impression about the drug’s safety.”

The letter also states OPDP’s additional concern that the opioid abuse epidemic is “a critical public health matter,” and that promotional material describing abuse-deterrent properties should list specifics and be displayed with sufficient prominence. “Opioid drugs with abuse-deterrent properties still expose users to the risks of addiction, abuse, and misuse,” OPDP said.