CommonSense Blog

Two Scary Words and Three Questions for the FDA

By Adam P. Silverstein | May 16, 2013

Quick. Word association. What are two words from the FDA that healthcare marketers and communicators almost universally fear and dread?

The answer: Warning Letter (but I’ll admit “not approved” is also at the top of the list!)

For those unfamiliar, the FDA, and in this case the Office of Prescription Drug Promotion (OPDP) issues warning letters when a company or organization insufficiently or inaccurately communicates a medical product or device’s benefits and risks. This includes not fully describing the side effects associated with a product or using language or visuals that imply a product treats a certain condition which the FDA has not approved. A warning letter is what it sounds like; a cautionary notice – “Strike 1” to use a baseball analogy – from the FDA that a company should consider revising its communications to avoid enforcement action.

Of course, Warning Letters can be viewed through different lenses, with the chance for confusion. It’s like the batter who thinks he’s received ball four when the umpire calls strike 3. Different interpretations and views of the information, and the warning letters themselves, in healthcare communications can seriously impact future marketing efforts much like disagreements over the strike zone can affect a game’s outcome.

Luckily, the FDA does not issue warning letters without explanation or allowing for questions. Today at 11:30 a.m. ET, the OPDP will host an Enforcement Webinar that lets viewers directly communicate questions on Warning Letters and Untitled Letters November 2012 through March 2013.

During this time, the FDA issued six Untitled Letters for misleading claims about the efficacy or risks associated with products treating a variety of diseases and conditions.

Here are the three questions that I’d like the OPDP to answer today:

  • Looking forward, do you have a sense of particular areas of concern when it comes to trends you’ve seen with drug promotion? For example, are you seeing more violations in terms of overstating efficacy claims or understanding potential risks?
  • There was only one online letter dealing with a company’s web site and podcast. What are your primary concerns regarding potential violations on digital platforms? Where do you see the biggest risk for sponsors?
  • How do you plan to include the information you’ve used for these Untitled Letters in whatever policy FDA eventually issues regarding social media promotion?

I’ll be live-tweeting tomorrow’s meeting using the hashtag #FDAletters. Please follow along and look for another update on this blog later this week. And if you have additional questions for the FDA, please leave them in the comments section. I’d love to see them.