Life Science Compliance Update

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April 13, 2018

OPDP Sends First Untitled Letter of 2018

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Here we are…barely finished with the first quarter of 2018, and the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has finally issued its first untitled letter of the year. The letter, sent to Collegium Pharmaceutical, dealt with an exhibit promoting the company’s opioid drug Xtampza ER (oxycodone).

The exhibit in question was Collegium’s exhibit booth at the American Society of Health-System Pharmacists’ summer 2017 meeting. The exhibit promoted Xtampza ER, which is an opioid approved for managing "pain severe enough to require daily, around-the-clock, long-term opioid treatment" and is limited for use in patients who have exhausted other treatment options such as non-opioid analgesics and immediate-release opioids. The drug is also approved for abuse-deterrent label claims for being resistant to manipulation by cutting, crushing, grinding, chewing and dissolving.

According to the FDA’s letter, "the exhibit booth makes false or misleading representations because it fails to adequately communicate information about the serious risks associated with Xtampza ER use." FDA notes that an OPDP official saw the exhibit in person at the event and that the side panel "utilized a much smaller font size and plain white background, without any visual elements linking it to the principal display panel."

Specifically, the “exhibit booth presentation included a principal display panel that prominently presented benefit claims about the abuse-deterrent properties of Xtampza ER, but failed to include any information with respect to the drug’s limitations of use, which state that due to the risks of addiction, abuse, misuse, overdose and death, Xtampza ER should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Nor did the principal display panel include any information with respect to the indication or serious and life-threatening risks such as those contained in the product’s BOXED WARNING.”

Further, while some of the benefit claims regarding Xtampza ER’s abuse-deterrent properties were prominently presented at eye level and easy to read, material information from the regarding the limitation of such properties in preventing abuse was almost hidden, presented at the bottom of the panel near the floor.

FDA also notes that the issues present in the exhibit are similar to ones FDA addressed in feedback to Collegium in 2016, where OPDP recommended that Collegium revise proposed presentations so that they did not misrepresent the approved indication or omit 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. We are concerned that Colleguim is promoting Xtampza ER in a manner that fails to address the very serious risks of the drug, despite this direction from OPDP," FDA writes.

OPDP has requested that Collegium stop violating the FDC Act and submit a written  response to the letter stating its intent to comply with the request, listing any and all promotional items for the drug with the statements outlined in the letter, and what the plan is for discontinuing the violative promotions.

We will have a more in-depth review of this letter, and what it may mean for industry overall, in an upcoming issue of Life Science Compliance Update.

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