Pharma Brands: Does Your Direct to Consumer Advertising Meet FDA Guidelines?

Pharmaceutical brand managers began advertising to consumers through print, radio, and television in the early 1990s. Wider adoption of the Internet led consumers to participate in their own health care decisions, prompting pharma companies to add a direct-to-consumer (DTC) strategy to support marketing efforts to healthcare professionals (HCPs).

A 2004 U.S. Food and Drug Administration survey showed, by that time, most physicians viewed DTC ads as a contributing factor to their patient interactions. In general, DTC ads allow patients to have greater awareness of treatments for their conditions and better discussions with their doctors.

 

Direct-to-Consumer Ad Disclosure Guidelines

FDA guidelines provide pharma brand marketers with a few fundamental requirements for DTC ad publication. An ad must present at least one FDA-approved use for the drug. In addition, the ad must include the generic name of the medication. Finally, DTC ads must disclose all risks associated with the drug’s use. (However, there are circumstances where only the most important risks must be disclosed within the advertisement.)

On the other hand, the FDA provides guidance on what DTC ads are NOT required to disclose. For instance, drug cost or availability of a generic version of the drug. The ad also does not have to indicate how quickly relief can be achieved.

 

Quantitative vs Qualitative Disclosures

Per FDA guidelines, as part of their development of DTC ads, pharma brands should consider how to “best convey information about a drug’s efficacy and risks so the intended audience understands it, including consideration of whether to provide efficacy and risk information by using words, numbers, or visual aids, or a combination of these elements.”

Recent research suggests consumers can comprehend risk and efficacy information when it is conveyed quantitatively versus qualitatively. As such, the FDA believes that a change in presenting such information within DTC ads in a quantitative manner instead of qualitatively may increase audience comprehension.

The FDA released a draft guidance in 2018 on how brands should advertise efficacy and risk information via DTC advertising (and promotional labeling). According to the draft guidance, “Quantitative information can improve consumers’ accuracy in estimating the drug’s benefits and risks.”

 

FDA Violations Under DTC Guidelines

There are several ways in which a direct-to-consumer ad may violate the law. For example, the ad may make claims that aren’t supported by adequate evidence. In some cases, a violation can occur when a brand directly states or suggests that the drug can treat a condition when the FDA has not approved the drug for such use. Additional violations include:

• Misrepresentation of data from studies
• Overstating the drug's benefits
• Omitting or minimizing risk information
• Failing to present a "fair balance" of information about the drug's risks and benefits
• Appearing to be a "reminder ad" but making a claim about the drug (Learn more about reminder ads)

You can find more information regarding violations here.

 

DTC Advertising Enforcement

So, what does the FDA do if it determines that a direct-to-consumer ad violates the law? The agency has various actions it can take. In most cases, it will send a letter to the offending party explaining the violation that has occurred. The letter will request removal of the ad from existing marketing channels.

In some cases, the FDA will request the drug company fix the misimpression made by the ad before republishing or rebroadcast. The required remedy may be to publish a corrective ad instead for situations where “the misimpression poses a serious threat to public health.”

In cases of extreme negative impact on public health, the agency may take additional enforcement action, including criminal proceedings and even seizing drug supplies.

For more information on DTC ads:

Pharmaceutical Research and Manufacturers of America® (PhRMA) Guiding Principles for DTC ads

Early impact of DTC advertising

FDA direct-to-consumer ad FAQs

 

Want to learn more about some trustworthy advertising options? Contact an Elsevier's Sales Representative today.

 

Article written by: Alex Brown