Print and TV ads for erectile dysfunction drugs should appear only in programs or publications with an adult audience of 90% or more under revised PhRMA consumer advertising guidelines—in the original version, released in August 2005, the baseline was 80%—and signatory company CEOs and chief compliance officers must sign an annual certification stating that they have policies and procedures in place to foster compliance with the principles.
Those are arguably the most substantive changes to PhRMA's Guiding Principles for Direct to Consumer Advertisements About Prescription Medicines, a revised version of which was released last month. PhRMA hopes the guidelines will blunt movement in Congress to impose new restrictions on DTC ads by demonstrating the industry's willingness to police itself, though the revisions consist largely of reiterations of existing principles and regulations.
Conspicuously absent is a minimum wait period before which companies can launch consumer advertising on new products, though companies are now “encouraged to consider individually setting specific periods of time, with or without exceptions, to educate healthcare professionals before launching a branded DTC television or print advertising campaign.” Many have already done so under pressure from Congressional barons like Reps. Henry Waxman, John Dingell and Bart Stupak, who have proposed two-to-three year moratoria on ads for new drugs.
Indeed, Dingell and Stupak promptly issued a statement “commending” PhRMA for the rethink but expressing disappointment over the lack of the two-year moratorium they've pressed for.
The guidelines include new language on the balance of risk and benefit information, stating that risk and safety information, including the substance of relevant boxed warnings, should be “presented with reasonably comparable prominence to the benefit information, in a clear, conspicuous and neutral manner, and without a distraction from the content.” Companies are encouraged to “seek and consider feedback” from patients and professionals in developing new campaigns.
In a nod to AMA concerns and, in part, the brouhaha over Lipitor ads featuring artificial heart inventor (and non-practicing physician) Dr. Robert Jarvik, the guidelines now require that actors in TV and print drug ads be labeled as such and that ads acknowledge any compensation to healthcare professionals appearing in them. Ads featuring celebrity endorsers “should accurately reflect the opinions, findings, beliefs or experience of the endorser,” and companies “should maintain verification of the basis” of the endorsement, including whether the endorser has used the product.
The guidelines also stipulate: TV ads should be submitted to FDA before being broadcast; print ads should include FDA's MedWatch number and website for adverse events reporting, as required by law; and that ads should not promote off-label uses. Companies are encouraged to promote health and disease awareness information, include information about the availability of diet and lifestyle options, where appropriate, and to include information about help for the uninsured and underinsured.