OPDP Sends First Untitled Letter of 2018

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 abo...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs