Drug Ads Skirt FDA RegulationsBy Kristina Fiore, Staff Writer, MedPage Today
Published: August 22, 2011
Reviewed by
Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Most advertisements for drugs are out of bounds when it comes to complying with FDA regulations on advertising to doctors, researchers found.
During a one-month period, about half of ads missed the mark on at least one rule, and about a third were "possibly" non-adherent due to missing information, according to Deborah Korenstein, MD, of Mount Sinai School of Medicine in New York, and colleagues.
As well, more than half failed to quantify serious risks, they reported online in PLoS One.
Action Points
■Explain that most advertisements for drugs are out of bounds when it comes to complying with FDA regulations on advertising to doctors.
■Note that in addition, more than half the drug ads failed to quantify serious risks.
Although the pharmaceutical industry has a $58 billion marketing budget, the FDA's division of drug marketing and advertising has significantly less -- just $9 million -- and thus can't review every ad that gets published.
In an effort to augment its sparse budget, the agency has recently implemented the "Bad Ad" program, in which it asks physicians to report non-adherent or misleading ads.
The FDA's guidelines, however, are subjective and challenging to enforce, and don't emphasize transparency or include basic information relevant to prescribing, the researchers said.
In order to assess "bad ads" via the current criteria, they searched the November 2008 issues of nine journals for drug ads. The journals were:
•Annals of Internal Medicine
• Archives of General Psychiatry
•Blood
• Circulation
•Hepatology
• JAMA
•Journal of the American College of Cardiology
• Journal of Clinical Oncology
• New England Journal of Medicine
There were a total of 193 ads, with 89 unique ads for 82 products. After cutting six ads that were just "teasers," the total sample included 83 ads.
Overall, just 18.1% of the ads adhered to all FDA guidelines, Korenstein and colleagues found.
About half (49.4%) failed to comply with at least one FDA-mandated item, and 32.5% were possibly non-adherent due to incomplete information
The most common reasons for being non-adherent were misused references to the literature, and using graphics in a way that are misleading. Ads were often "possibly" non-adherent because they didn't cite references or overrepresented the experience with the drug.
"There was no single problem that was consistently identified for non-adherence," the researchers wrote.
They noted that there were differences in non-adherence by the product indication category.
Non-adherence to at least one FDA item was seen
in 60.5% of hematology/oncology products,
in 52.9% of cardiovascular and diabetes products, and
in 28.6% of psychiatric products.
Korenstein and colleagues also found the ads were incomplete in terms of safe prescribing information:
57.8% didn't quantify serious risks;
48.2% lacked verifiable references; and
28.9% failed to give adequate efficacy quantification.
"Advertisements do a poor job of conveying basic information necessary for safe prescribing, with the majority failing to quantify serious risks," they wrote.
Still, they noted that overall, "despite the high rates of FDA non-adherence, the mean number of biased features in each advertisement was low, and most advertisements we reviewed satisfied the majority of FDA guidelines."
However, they cautioned that FDA guidelines don't target ad features that are highly relevant for informing prescribers.
For instance, they wrote, an ad with no specific efficacy claim, no quantification of drug safety, and no verifiable references would fully adhere to FDA guidelines.
Now the FDA has stepped up its game with the "Bad Ad" program, Korenstein and colleagues said the agency needs to update and simplify its guidelines --
make them straightforward and objective, they said, and require ads to give clear risk quantification, information on absolute benefits, verifiable references, and describe the appropriate population for drug use.
The study was limited by its cross-sectional nature as it focused on ads published during only a single month.
The subjectivity of the FDA guidelines, and the subjectivity of determining adherence were also limiting factors.
The authors did not report any disclosure or conflicts of interest.
This article was developed in collaboration with ABC News.
Primary source: PLoS One
Source reference:
Korenstein D, et al "Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing" PLoS One 2011; DOI: 10.1371/journal.pone.0023336.
© 2011 Everyday Health, Inc. All rights reserved.
http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/
28141?utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=
