Scary Pharma/Drug Ads in Medical Journals

Drug print ads aimed at patients are usually upbeat showing the benefits of the pill. Print ads intended for physicians on the other hand are often dark and downright scary. I came across this medical journal print ad about "poorly controlled LDL-C" yesterday:

Click on image for an enlarged view

What's up with this?

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Disclosing Risk in DTC Print Ads: Introducing the "Consumer Brief Summary"

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. One document was titled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”

“Our new regulatory guidance,” said Mark B. McClellan, M.D., Ph.D., FDA Commissioner at the time, “provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn't in drug promotion” (read "FDA Draft Guidance for Print DTCA: Less than Feared").

But now even NEWER evidence - and complaints from the pharma industry - forced the FDA to issue a "revised draft guidance" titled "Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs," which you can find here (Docket No. FDA-2004-D-0500).

Released on February 9, 2015, this revision was ELEVEN years in the making. Compared to that, the four years FDA took to issue draft social media guidelines was lightening fast.

The guidelines address the requirement under provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require that an advertisement for a prescription drug to disclose each side effect, warning, precaution, and contraindication from the labeling. This is referred to as the "brief summary requirement."

So what's new in the guidelines?

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Critique of an Ad Seen in "Modern Pharma Guidance" Magazine

The ad shown on the left is the subject of an FDA/OPDP "untitled letter" (definition), which took aim at a Sunovion professional print ad for seizure med Aptiom.

According to the FDA reviewer of the ad: “Although Aptiom may reduce seizure frequency, FDA is not aware of substantial evidence demonstrating any effectiveness of Aptiom on patients' feelings of confinement associated with seizure."

A typical letter for a typical drug ad seen in a physician-targeted publication/journal.

Imagine, if you will, a parallel world in which exists a trade publication for pharmaceutical legal/regulatory professionals. Let's call the publication Modern Pharma Guidance™. 

I envision this mag containing articles that review FDA guidance documents and the industry's response to those guidances. You know, very similar to these Pharma Marketing News articles: PhRMA Tells FDA How It Wants to Correct "Misinformation" and FDA Tweet Blocks Pharma.

What would the ads look like in Modern Pharma Guidance, assuming the ads are designed by the same agencies that design drug ads in physician journals?

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