Let's take a look at what has been happening at the FDA over the past year. The Division of Drug Marketing, Advertising, and Communications (DDMAC)—which oversees regulations for pharmaceutical advertising—has been busy.
Uptick in notices of violations
It's no secret that over the past few years, DDMAC sent pharmaceutical companies more notices of violations (NOVs) than it used to. MM&M (Medical Marketing & Media) reported a 26% increase in NOVs in 2010 over 2009. The number of NOVs sent in 2010 was more than double those sent in 2008.
Why the increase? One reason may be that the FDA used to require counsel review on every letter before it was sent. That requirement was recently lifted, eliminating a barrier to quick enforcement.
Of the 52 letters DDMAC sent in 2010, 13 were warning letters. These notifications of serious violations are sent directly to a pharma company's CEO. The rest were untitled letters (a nondescript name the FDA uses for violation letters that are a notch down from warning letters).
Which media were targeted?
Print materials commanded the lead in violations (more than 64% of all violations given out), followed by Web/digital and then TV/audio. And while materials directed to healthcare professionals were more often cited by DDMAC, 38% of all letters concerned consumer materials.
As is often the case, direct-to-consumer (DTC) ads took a few hits. With the FDA's Bad Ad Program in full swing (a new initiative that encourages doctors to report to the FDA misleading information they see in advertising and promotional materials), we can expect an increase in the number of letters sent about ads and other materials. In December 2010, the FDA issued its first NOV arising from the Bad Ad Program.
Patient videos also were cited for a variety of reasons. In a workshop at the recent NYC ePharma Summit, Mark Senak of the Fleishman-Hillard communications firm remarked that by using patient testimonials, a pharma company could inadvertently broaden a drug's effectiveness claims and indication. He was quick to point out that a customary disclaimer such as "a patient's experience may not be typical" is no longer a safe harbor for advertisers. To this I add that the typical placement of safety information at the the end of a branded 15-minute video was also called into question by the FDA in 2010. DDMAC stated that for fair balance, the safety information must be closer to the beginning of the video. Guidance about exactly where to place the safety information was not forthcoming. At the 1-minute mark? The 3-minute mark?
In the area of social media, the FDA for the first time cited a Facebook entry. The safety language on the Facebook page did not travel with the information once it was "shared." It seems that as with Web sites, FDA guidance for social media will come via violation letters. Formal Draft Guidance, in the works since 2009, has not yet been published.
Most prevalent violations
One trend that is not new this year in violations? Omission or minimization of risk in promotional materials continues to be DDMAC's "greatest hit." Of particular interest, though, is the increasing number of citations given for failure to use patient-friendly language to convey a drug's risks when simplified language touts a drug's benefits. HealthEd has been at the forefront in helping clients overcome this obstacle. We will continue to track this enforcement trend.
Overstating a drug's efficacy, making unsubstantiated claims, and broadening a drug's indication round out the other most prevalent violations cited by DDMAC in 2010.
What's to come?
Most industry speculation presumes that enforcement will stay high. However, issuance of NOVs slowed down in the second half of 2010, and momentum may be challenged by the proposed GOP budget cuts of $220 millon to the FDA. On the other hand, the FDA is in the midst of an upgrade from a government division to a government office and has asked for a 33% budget increase. Stay tuned!
VP, Editorial Services