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FDA issues a sharp warning letter rebuking AcelRx Pharmaceuticals for its ”glib and simplistic” messaging on painkiller Dsuvia.
In a highly publicized challenge to unbalanced marketing of an opioid painkiller, FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its glib and simplistic messaging on painkiller Dsuvia.1 The admonishment signals FDA’s intent to take strong action against misleading promotion of high-risk medicines, perhaps also seeking to deflect outside criticism of acting commissioner Janet Woodcock for supporting the approval of certain risky pain medicines when director of the Center for Drug Evaluation and Research (CDER).
FDA’s main objection in this case is that AcelRx’ s “tongue and done” headline highlights Dsuvia’s easy administration, while also minimizing product risks. FDA cites banner headlines with large type and illustrations touting a one-step administration process. At the same time, the message requires viewers to scroll through paragraphs of text to find limitations of use and important safety information.2 Such skewed messages here are doubly troubling to FDA, as this pain medicine is subject to a risk evaluation and mitigation strategy (REMS) to restrict its use, and its label carries a boxed warning highlighting the need to avoid misuse through careful monitoring and administration.
The agency’s criticism of this unbalanced presentation of risk/benefit information reflects a common complaint of pharma promotions and follows a 2009 draft guidance on the topic.3 This warning letter is the first compliance action taken by CDER’s Office of Prescription Drug Promotion (OPDP) this year and could be a signal of more actions of this sort to come. OPDP has been fairly quiet in recent years in challenging industry marketing activities, but this announcement aims to signal the agency’s “commitment to combat inappropriate opioid use” and its willingness to challenge violative marketing for high risk products in general, and opioid therapies in particular.
OPDP also is responding to changes brought by pandemic by doing more to challenge misleading or inaccurate messages related to treatments for COVID-19, according to a review of the Office’s annual report. In outlining priorities and programs for this year, acting OPDP director Katie Gray also notes a continued focus on ensuring balanced communications on high-risk drugs.4