OPDP’s Second Enforcement Letter in Two Weeks Targets Investigational Drug

Sept. 15, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has only issued four enforcement letters this calendar year, it issued two Untitled Letters within two weeks for the same alleged infraction: promoting an investigational drug. In a Sept. 8 letter to DURECT Corp. and Pain Therapeutics Inc. (remoxy-untitled-letter), OPDP raised concerns about Website presentations regarding REMOXY® (oxycodone) Extended-release Capsules that suggest that Remoxy ER, an investigational opioid drug, “is safe and/or effective for the purposes for which it is being investigated.”

“Conclusory statements regarding safety and effectiveness of a drug, made while an application for the product is under review, suggest an effort to shape public impressions of the drug in the lead-up to its launch, before FDA’s evaluation of the product is complete and reflected in approved drug labeling,” according to OPDP. “Such statements raise considerable public health concern and may remain probative evidence later when a product is in broad distribution. The statements are particularly irresponsible and alarming with respect to an opioid drug product.”

“OPDP continues to remind the industry and the public that its basic rules of marketing are fully in place,” said Coalition for Healthcare Communication Executive Director John Kamp.

The agency notes that statements about the product listed on the Durect main page, such as “long-lasting” and “tamper-resistant,” are “phrased as established facts,” which suggests that the product “is safe and effective with the characteristics described or otherwise promote the drug.”

OPDP also cites as problematic the following issues:

  • The presentation on the Durect site identifies the product under the trade name intended for use when commercially marketed;
  • Clicking on any part of the presentation on the Website main page links directly to a product-specific Webpage;
  • Prominent claims under the “product overview” and “potential benefits” headings suggest that the product is safe and/or effective;
  • Even though the product Webpage uses a heading titled “in development” in the local navigation sidebar and there is an indirect statement available under the “current status” heading which indicates that the product is not approved, such information is only visible to site visitors on the product Webpage who make an effort to expand the “current status” heading, “and even then, the statement cannot be viewed at the same time as the prominent assertions regarding Remoxy ER’s properties”; and
  • The Pain Therapeutics Website contains similar presentations.