PhRMA Enhances DTC Guidelines

Dec 17, 2008

In an effort to clarify some advertising grey areas—testimonials, paid spokespeople, etc.—PhRMA last week updated its guidelines for consumer advertising of prescription drugs.

The voluntary principles have been updated as follows:
• Actors playing physicians must be identified as such. If real doctors are used in the ad, the material must recognize that they are being paid to appear in the ad.
• Celebrity spokespeople must actually believe in, use, or have used the product they are endorsing, and companies must verify that the celebrity’s statements are true.
• Television and print ads must include or refer a patient to FDA’s MedWatch phone number to make it easier for consumers to report adverse reactions.
• It’s recommended that pharma companies allow a period of time to educate healthcare professionals about new drugs or expanded indications prior to the launch of a new consumer ad campaign.
• Drug ads featuring adult content (i.e., erectile dysfunction ads) should steer clear of youth-oriented television shows and publications.
• Risk information must be given as much airtime and print space as benefit content, without any distractions.

The new guidelines, which echo many of the changes the Federal Trade Commission made to its guidance earlier this month, will go into effect March 2.

“Whether [these guidelines] make any material difference remains to be seen,” said Peter Rost, former vp of marketing at Pfizer. “But it’s good that PhRMA is clarifying a lot of the specifics that have been in the guidelines since they were issued in 2006. I think that the principles and the goals remain the same, which is to ensure that DTC advertising is done responsibly.”

Pharmaceutical companies are not mandated to follow these guidelines, but most do so. From a policy standpoint, the PhRMA decree does not change any of FDA’s regulations, but the new guidelines could spur further, voluntary regulation. The original guidelines encouraged pharma manufacturers to submit DTC ads to FDA in advance of publication or broadcast.

“Pharmaceutical research companies for years have voluntarily exceeded regulatory requirements for direct-to-consumer advertising of prescription medicines,” stated PhRMA President and CEO Billy Tauzin in a release. “Our guiding principles help ensure that DTC advertising appropriately and accurately conveys important information about medical conditions, medicines, and other treatment options.”