When was the last time you read the fine print on a prescription drug, much less the two pages of boring clinical data that follows each drug advertisement in magazines? If you’re like most people, you skip right past.
The FDA knows this, and they’re now changing their tune to get manufacturers to focus on less, but more important data information in their drug ads.
For years, the agency required that pharma companies disclose all of the risks of their products from drug warning labels word-for-word. With the size restraints of magazine ads, this led to tiny print that most people passed over.
Earlier this year, the FDA issued a strong suggestion to companies that they list only the most important side effects, and do so in a larger, more visible manner.
The February 6th directive said the “"FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements, an approach in which risk-related sections of the [prescribing information] are presented verbatim, often in small font."
Instead, of including “less pertinent information, the FDA is calling for more "clinically significant" info. Look for larger question & answer sections, or quick fact boxes, say experts.
Also, the agency has asked that companies use less technical terms in their ads, so that the general public can better understand them. Instead of antiquated terms like “This use is contraindicated with…” the ads should simply say "Do not use if (or with)."
The changes come from recent FDA studies showing that consumers understood products better when ads focused on the most common or most severe side effects. Also, nearly half of people said they don’t pay attention to the full disclosure sections at the end of current drug print ads.
So far, the drug industry has welcomed the changes, according to a comment by the Pharmaceutical Research & Manufacturers of America.
DrugNews hopes the new ad format will result in fewer drug-related injuries and serious side effects.
FDA. Disclosing Risk Information in Consumer-Directed Print Advertisements. (February 2015). Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM069984.pdf
Gaffney, A. FDA Calls for Changes to Drug Advertising in Hopes of Increasing Patient Understanding. RAPS. (February 6, 2015). Retrieved from http://www.raps.org/Regulatory-Focus/News/2015/02/06/21267/FDA-Calls-for-Changes-to-Drug-Advertising-in-Hopes-of-Increasing-Patient-Understanding/
Staton, T. FDA to pharma: Scrap that fine-print risk info in DTC ads. FiercePharma. (February 9, 2015). Retrieved from http://www.fiercepharma.com/story/fda-pharma-scrap-fine-print-risk-info-dtc-ads/2015-02-09?utm_medium=nl&utm_source=internal
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