Prescription drug broadcast ads have been liberated from strict FDA advertising restrictions on "brand only" messages, which could only mention product brands - no indications. In response to growing requests from Rx manufacturers and some consumer advocacy groups for better explanations in broadcast Rx ads, the FDA has loosened its regulatory grip.
Hoechst Marion Roussel, the first company to launch direct-to-consumer prescription drug advertising back in the mid-'80s with its prescription allergy drug, Seldane, was also the first to test drive - on Aug.8 - the FDA's new guidelines on branded indication advertising for its Allegra antihistamine campaign.
After working with the drug watchdog group for two months on ways prescription drug ads could better explain product indications, Hoechst received pre-clearance to debut its nationwide fall launch of Allegra. (FDA approval is not necessary for these campaigns, but most drug manufacturers get their creative voluntarily reviewed by FDA's Division of Drug, Marketing, Advertising and Communications.) The spots now highlight key uses for the drug as well as important side effects and will run through the end of the year, according to Julie Gladman, senior communications specialist at Hoescht.
New FDA Guidelines
This latest FDA move loosens the reigns of "reminder advertising" which restricted drug manufacturers to mentioning product brands on the air but not what they could be used for. In lieu of providing a "brief summary" of product indications, the FDA is requiring advertisers to include the following components in their commercials:
Toll-free numbers for customers to access detailed product info;
Referencing direct-to-consumer print ads and brochures which contain more detailed indication info;
Inclusion of the Internet address (if applicable).
A statement that pharmacists and physicians may provide additional product info.
Hot on the trails of Allegra, Glaxo Wellcome recently launched its Valtrex (Herpes) broadcast campaign that gives consumers a snapshot of what Herpes symptoms these drug can be used for.
The FDA intends to keep a close watch on these kinds of ads to ensure that they are "truthful, not misleading, and contain information about the major health risks associated with the drug," according to Michael J. Friedman, M.D., the FDA's lead deputy commissioner.
Drug Still in 'Holding Pattern'
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Although Hoescht has made some headway with the FDA on Allegra, they are still in a holding pattern where Seldane is concerned. Earlier this year, the FDA wanted to snatch the popular antihistamine off the market because of the unsafe allegations surrounding its interaction with other common antibiotics, which reportedly lead to unstable heart rhythms and a number of fatalities. (See HPRMN, 1/23/97)
The trailblazing but controversial ad campaign was quickly followed by an Allegra promotional push to get Seldane users to convert to the safer alternative. Back then, the ads could only mention the brand.
Now, the ads offer an FDA approved "brief summary" of the drug's side effects: "Allegra may cause side effects. In studies, drowsiness occurred in one out of a 100 people. Others reported cold or flu, nausea, or menstrual pain. Anyone sensitive to its ingredients shouldn't take Allegra."
(FDA, Brad Stone, 301/443-3285; HMR, 816/966-4274)