Bad Ads – FDA Recruits Health Care Providers to Combat Misleading Advertising

If your advertising goes unnoticed, everything else is academic.

– William Bernbach

Fierce reported that the “FDA has issued 186 warning letters so far this year”.  (Looking at that number, they must mean “warning and untitled letters” which are frequently conflated).

Assuming that 1) this covers January through April only and 2) this pace continues, we’re on track to see well over 700 warning (and untitled) letters from the FDA this year.  That’s certainly a notable increase from recent years and establishes a definite upwards trend: 381 letters in 2007; 436 in 2008; and 570 in 2009.  But before any panic sets in, remember that these levels are still below the numbers from the 1990s.  For example, see the graph in this post from Eye on FDA about the FDA’s Division of Drug Marketing, Advertising, and Communications’ (DDMAC) letter writing over the past 13 years.

DDMAC, which regulates the advertising of prescription drugs, is always the leader of the letter-writing charge.  They constantly monitor advertisements for violations.  However, they’ve elected to call in additional support by asking health care providers (HCPs) to participate in their new initiative called the “Truthful Prescription Drug Advertising and Promotion (Bad Ad Program)”.

The primary aim of the Bad Ad Program is to “help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”  It was announced on the heels of some surprising warning letters over unbranded websites and further demonstrates that Margaret Hamburg (FDA Commissioner) was not bluffing when she stated that she wanted to increase surveillance and enforcement activities.

In the first phase of this program, DDMAC will attend HCP meetings and distribute educational material to encourage any HCP to report suspected violations.  To give you an idea of what DDMAC is saying to HCPs, here is some text from their example brochure:

Prescription drug advertising must:

• Be accurate
• Balance the risk and benefit information
• Be consistent with the prescribing information approved by FDA
• Only include information that is supported by strong evidence from clinical studies

What types of promotion does DDMAC regulate?

• Sales representative presentations
• Speaker program presentations
• TV and radio advertisements
• All written or printed drug promotional materials

DDMAC does not regulate promotion of:

• Over-the-Counter Drugs
• Dietary Supplements
• Medical Devices

Common Violations:

• Omitting or downplaying of risk
• Overstating the effectiveness
• Promoting off-label, or unapproved, uses
• Misleading drug comparisons

In the FDA’s press release, Thomas Abrams, director of DDMAC, said

“We are asking doctors to increase their awareness and report questionable activities to us.”

He also told Reuters:

“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency.”

The next two phases will be a refinement of how to encourage and suport reporting amongst HCPs.  Although this program is targeted towards “prescribers”, it’s hard to believe that they would not review complaints by non-prescribers.  Also, remember that just because a complaint is filed, a warning letter is not guaranteed to follow.  DDMAC will investigate and accumulate evidence first.

I’ve heard a few different arguments about the merits of the Bad Ad Program; they generally break to 3 points:

1. It will not have a significant impact on HCPs and, therefore, will not improve promotional compliance.
2. It will generate so many reports of possible violations that the agency will not be able to sift through them in a meaningful way.
3. Regardless of whether 1 or 2 is true, even the threat of (non-DDMAC) increased surveillance will encourage compliance.

I’m still of two minds on whether 1 or 2 is more likely.  Having spent more than 6 years in a medical center, I know that many HCPs find sales reps more of an annoyance than anything else, so that alone may foster a desire to tattle.  However 3 is certainly spot-on.

If you’re an HPC and want to report a possible “Bad Ad”, here’s how you can contact DDMAC:

• Phone: 877-RX-DDMAC (877-793-3622)
• E-Mail: BadAd@fda.gov
• Write: FDA/CDER/DDMAC, 5901-B Ammendale Rd. Beltsville, MD 20705-1266
• Fax: 301-847-8444