Last year, the FDA acknowledged the difficulty in policing advertisements aimed at healthcare professionals and consumers by creating its 'Bad Ad' program, which the agency recently maintained is having a positive effect (read here). But just how bad were pharmaceutical ads before the FDA launched this program?
To gain some clarity, researchers examined 192 pharmaceutical ads that ran in biomedical journals in November 2008 - less than two years before the 'Bad Ad' program began - and found that only 18 percent were compliant with FDA guidelines. And more than half failed to quantify serious risks, including death, according to their study, which was published PLoS One.
To be more specific, of those 192 ads, which were promoting 82 unique meds, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines (read here). Meanwhile, 57.8 percent of the ads did not quantify serious risks, 48.2 percent lacked verifiable references and 28.9 percent failed to present adequate efficacy quantification.
Many advertised drugs in the sample presented potential risks - 31 contain black box warnings and 33 place patients at risk for death or serious morbidity. And 36 ads, by the way, referenced “data on file” and 40 lacked verifiable references, due either to an absence of any references or to the presence of references only to data on file or the product’s package insert, the researchers found.
Which journals qualified for their review? The Journal of the National Cancer Institute; JAMA; Gastroenterology; Annals of Internal Medicine; Archives of General Psychiatry; Blood; Circulation; Hepatology; Journal of the American College of Cardiology; Journal of Clinical Oncology, and The New England Journal of Medicine (n=35).
Ads were considered adherent if they contained none of the 21 features used by FDA to classify ads as misleading non-adherent if they contained one or more of the features used by FDA to classify ads as misleading, and possibly non-adherent if there were no features clearly defining a misleading ad but at least 1 of those items for which information was incomplete, the researchers wrote.
The researchers found statistically significant differences in non-adherence rates to FDA guidelines by item content. Nine ads, or 10.8 percent, were non-adherent to at least one FDA item focused on safety, while 18, or 21.7 percent of ads, were non-adherent to at least one FDA item focused on efficacy and 16 ads were non-adherent to at least one item focused on references.
"Advertising is a form of free speech and is a constitutionally protected right of industry," the researchers write. But, "current FDA guidelines are subjective and challenging to enforce and do not emphasize transparency and the inclusion of basic information relevant to prescribing. Increased enforcement of the current regulations would help improve advertisements, but the subjectivity of the guidelines presents a substantial barrier."
"The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” Deborah Korenstein, lead author of the study and associate professor of Medicine at Mount Sinai School of Medicine, says in a statement (here is the complete study).