Print and TV ads for ED 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 today. PhRMA hopes the guidelines will blunt movement in Congress to impose new restrictions on DTC advertising 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.
"On one hand, PhRMA has taken our committee's concerns seriously by revising parts of their DTC code,” said Stupak. “On the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection. Our investigation will continue, and we will be keeping a watchful eye on how well the industry follows these guidelines."
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, 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 that: TV ads should be submitted to FDA before being broadcast; print ads should include FDA's toll-free MedWatch number and website for adverse events reporting, as is 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.
AstraZeneca, a top industry advertiser, hailed the new guidelines, noting that it had already implemented many of its recommendations, including reviewing broadcast ads with patients and physicians for tone, content and clarity of benefit/risk messages and including patient assistance information.
“Our goal is to help the right patient get the right medicine at the right time,” said AstraZeneca VP, marketing and sales Mark Mallon in a statement. “These expanded guidelines will benefit patients and their doctors by helping to ensure that information included in DTC advertisements is not only relevant, balanced and accurate, but also encourages conversations between patients and their doctors.”
John Kamp, executive director of the Coalition for Healthcare Communication, called the guidelines “not dramatic but still important steps forward,” but acknowledged that the changes wouldn't sway Congressional critics like Waxman and said his group remains “seriously concerned about Congressional and regulatory efforts to limit broadcast DTC and the possible spill-over into Internet and other innovative consumer and professional marketing.”