OPDP to Industry: Voluntary Compliance Efforts in New Year Can Prevent Same Old Violations

Jan. 6, 2011 – As the pharmaceutical industry begins 2012, the FDA’s Office of Prescription Drug Promotion (OPDP) recommends that companies focus their efforts on many of the common problem areas faced by their competitors in the last quarter of 2011, according to OPDP Regulatory Counsel Julie Chronis.

When asked by the Coalition for Healthcare Communication what advice OPDP might have for industry in the new year, Chronis, speaking at a Dec. 19, 2011, OPDP Webinar on Q4 enforcement actions, said: “I’ve got two words for you: Voluntary Compliance.”

“We are not off on a witch hunt, but are looking for companies to do the right thing,” she said, while suggesting that companies should both “look at our enforcement actions, guidance and regulations, which are “resources companies can use to assist them in their voluntary compliance,” and  submit materials for advisory comments.

The OPDP issued eight Untitled Letters and no Warning Letters during this time period. The Untitled Letters cited a variety of alleged violations, as follows:

  • Omitting or minimizing risk information
  • Making unsubstantiated claims, including unsubstantiated superiority claims
  • Overstating the efficacy of the products
  • Omitting material facts
  • Failing to communicate the indication in an adequate manner
  • Promoting unapproved uses
  • Inappropriate reminder labeling
  • Presenting misleading claims
  • Inadequate presentation of the established name

Although there were no particular trends noted in these enforcement actions, OPDP Regulatory Counsel Bryant Godfrey stated that OPDP “consistently sees the same types of violations, including omission of risk information, failure to communicate the indication, overstatement of efficacy and omission of material fact. These are some of the violations we see time and time again.”

Indeed, a number of questions posed to the speakers centered on when and how to provide risk information. An Oct. 25, 2011, Untitled Letter to Lantheus Medical Imaging for its TECHNELITE product states that an exhibit panel “makes several efficacy claims for Technelite, but omits material risk information for the drug” and in so doing, “misleadingly suggests that Technelite is safer that has been demonstrated by substantial evidence or substantial clinical experience.”

One Webinar participant asked why it was necessary to include all of the risk information mentioned in the enforcement action when the exhibit panel had so few claims. “The type of risk information is going to be very specific to that drug and the drugs in that class,” explained Chronis. “We are always going to want to see the most serious risks, along with the most commonly occurring risks. So, we refer you to the draft guidance that’s available on our Web site to give you more information on which risks we are going to want to see,” she said.

Another participant inquired why the firm including the phrase, “Please see a representative in this booth for full Prescribing Information,” was not a sufficient way of providing safety and risk information.

“There are a variety of reasons,” Chronis stated. “One, it’s entirely possible that the sales rep would leave the booth and not be available to talk to the people who stop by. Also, there are people who walk by and do not have the time or opportunity to speak to that rep,” she continued. “We would

like to see risk information more accessible than just being available through one person in one specific place.”

When asked about the general success of the Bad Ad program in leading to enforcement actions, Voyard said that “doctors really seem to understand what we consider a violation and give us some very pointed complaints and accounts of what they’ve seen. In my view, I think it’s been working.” Chronis remarked that OPDP will continue to promote the Bad Ad program in 2012, and will begin holding CME events “to further educate health care professionals about the program and the work we do.”

The Webinar’s moderator, Sangeeta Vaswani-Chatterjee, OPDP regulatory counsel team leader, indicated that the agency has received positive feedback on the quarterly enforcement Webinars and plans to continue holding them in the future.