May 28, 2013 – The FDA’s Office of Prescription Drug Promotion (OPDP) continues to cite industry for overstating efficacy, minimizing or omitting risk and making unsubstantiated claims, according to six untitled letters issued by OPDP from November 2012 through the end of March 2013. At a recent OPDP Enforcement Webinar, OPDP regulatory counsel staff members discussed specific problems it found with various promotional claims, and responded to questions about online promotional guidance and the agency’s approach to enforcing misbranding violations in the wake of the recent U.S. v. Caronia decision.

An OPDP enforcement letter to Alcon Research Ltd. regarding PATADAY™ stated that promotional materials for the drug touted “zero itch” associated with its use. OPDP states that such claims overstate efficacy “because they suggest that all patients who use Pataday will experience ‘zero-itch’ and be symptom-free.” The letter also states that the company made unsubstantiated superiority claims about zero itch.

“The study cited for the zero-itch claim was a post hoc study and was not considered substantial evidence;” said OPDP Regulatory Counsel Cynthia Ng. “Substantial evidence is generally demonstrated through two adequate and well-controlled trials.” She clarified that a study “does not necessarily need to be published to support efficacy claims, but the data need to be readily accessible if OPDP requests it.”

In response to a listener question regarding the promotion of investigational uses of a drug on a Website and in a podcast, OPDP Regulatory Counsel Julie Chronis stated that companies “can discuss investigational uses for their drugs, but they have to do it in an appropriate manner.” She noted that Salix Pharmaceuticals Inc. and Napo Pharmaceuticals were cited by OPDP in an enforcement letter for discussing investigational uses for the drug CROFELEMER tablets in part because they indicated that the drug was safe and/or effective for children as young as three months, which it states has not yet been proven.

Other enforcement letters issued during this period alleged the following violations:

• Omission of material fact;
• Omission and minimization of risk;
• Unsubstantiated superiority claims;
• Unsubstantiated efficacy claims;
• Overstatement of efficacy; and
• Inadequate communication of indication.

In the absence of long-awaited OPDP guidance regarding online promotion, one Webinar attendee asked whether OPDP would be issuing guidance on how companies can properly promote their drugs using social media, such as Facebook and Twitter.

“We publicly announced that we would be publishing several Internet guidances, one of which [on unsolicited requests] has already been issued,” OPDP Regulatory Counsel Robyn Tyler said. “So that these guidances don’t quickly become obsolete because of the ever-changing technology, the guidances won’t be just for a specific medium like Facebook or Twitter.” She did not address the million-dollar question regarding when additional guidance on electronic media promotion could be expected.

The OPDP panel also was asked whether OPDP would change its enforcement approach toward drug misbranding in light of the recent U.S. Court of Appeals for the Second Circuit decision in U.S. v. Caronia. “That’s a good question. No significant changes with be made to the enforcement process in light of the Caronia decision,” Tyler responded. “This is based on the determination by the court that the promotion of a drug for an unapproved use is an intended one and that a drug that lacks adequate directions for its intended use is misbranded. Additionally, because the court also acknowledged that the First Amendment does not preclude an enforcement action based on unapproved uses that are false or misleading, OPDP will continue to enforce the misbranding provisions of the Food, Drug & Cosmetic Act.”

When asked whether OPDP could provide some tips to companies to help them avoid getting an enforcement letter, Tyler advised industry to:

• Review OPDP guidance documents;
• Look to posted enforcement letters for how OPDP has treated similar situations/claims in the past; and
• Utilize the advisory comment process.

“Companies have the resources that they need to best insulate themselves from receiving an OPDP enforcement letter,” Tyler asserted.