OPDP Untitled Letters on PR Materials Surprise Industry

Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone Therapeutics Inc. for CUROSURF Intratracheal Suspension sent a strong message to medical public relations professionals because it was one of two enforcement letters issued within a two-week period that cited press materials, not the advertising and marketing collateral that OPDP typically targets.

An Oct. 18 letter regarding an investigational product also cited press releases, as well as embedded videos that were posted on a research entity’s Websites.

“While FDA seldom cites public relations materials in enforcement letters, it did so twice recently,” said Coalition for Healthcare Communication Executive Director John Kamp. “Whether it’s a warning shot or a coincidence, it’s time for PR shops to brush up on the rules.”

Specifically, OPDP alleged in the letter to Cornerstone that a professional pitch letter with an attached press release

for CUROSURF is false or misleading because it omits important risk information associated with the use of the drug and that the pitch letter and the press release are false and misleading because they present unsubstantiated superiority claims.

This enforcement letter drew the first question during an OPDP Enforcement Webinar held Nov. 19. A caller asked: “Since the enforcement letter acknowledges that the company’s press release accompanies the pitch letter, what was the rationale for determining the pitch letter must include risk information?”

Robin Tyler, OPDP regulatory counsel, replied that “the healthcare professional pitch letter and press release were intended to be distributed together, but each of these promotional materials is a stand-alone piece, therefore they both require risk information.”

This position is not one that has been enforced explicitly in the past, according to several industry experts. Wayne Pines of APCO Worldwide told Medical Marketing & Media that “OPDP has viewed press materials as promotional labeling for many decades.” He noted, however, that “the pattern of enforcement letters indicates that press materials have not been a high priority for enforcement” and may be a “wake up call” to companies that do not use the same standard for press materials as they do for other forms of promotion.

During the Webinar, OPDP enforcement officials discussed a broad range of alleged violations and reiterated past comments that they are looking for voluntary compliance from industry. OPDP also listed the common alleged violations cited in two Warning Letters and 16 Untitled Letters issued from May 2012 through October 2012, which included:

  • Omission/minimization of risk
  • Unsubstantiated claims (including unsubstantiated superiority claims)
  • Overstatement of efficacy
  • Omission of material facts
  • Broadening of indication
  • Inadequate communication of indication
  • Promotion of unapproved uses
  • Inappropriate reminder labeling
  • Misleading claims/presentation
  • Failure to fulfill “adequate provision” requirement
  • Failure to submit under Form FDA-2253
  • Inadequate presentation of established name

In response to various questions from viewers regarding specific enforcement letters, OPDP officials stated that industry should consider the prominence of risk information as it relates to benefit information, avoid expanding indications with claims, ensure that patients used in testimonials represent “typical” patients, and use only primary endpoints as the basis for promotional claims. Several

OPDP officials also advised companies to actively discuss their promotional approach with OPDP review divisions.

“One of the ways we really promote is for industry to send in pieces for advisory comment, especially if they are doing something slightly different or have a new campaign,” according to Ernest Voyard, OPDP regulatory counsel. “We are here to help with review and we encourage industry to take advantage of it,” he said.