From March 2, direct-to-consumer (DTC) advertising for prescription drugs in the USA must show clearly if the health care professionals who appear in the ads are in fact actors, while if genuine health professionals are used, and paid for appearing, this must also be apparent, say new industry guidelines.

Moreover, if celebrity endorsers appear in DTC ads, these “should accurately reflect the opinions, findings, beliefs or experience of the endorser,” according to the Pharmaceutical Research and Manufacturers of America (PhRMA)’s newly revised voluntary Guiding Principles on DTC Advertisements about Prescription Medicines.

A revised Principle also states that DTC television or print ads “containing content that may be inappropriate for children” should be placed in programmes or publications “reasonably expected to draw an audience of approximately 90% adults (18 years or older).” This new restriction is likely to affect TV advertising for erectile dysfunction drug treatments.

PhRMA points out that DTC advertising has been shown, “in numerous studies and surveys,” to play a key role in educating and empowering patients, improving patient understanding of disease and available treatments and fostering strong relationships between patients and their healthcare providers. By facilitating patient-physician interactions, DTC advertising helps reduce undiagnosed and under-treated serious conditions, benefiting not only individual patients but also the entire healthcare system, it adds.

The industry group also states that its members have “for years” voluntarily exceeded regulatory requirements for DTC ads, but critics in Congress say the new voluntary guidelines do not go far enough. Democratic Representative John Dingell, the outgoing chairman of the House Committee on Energy and Commerce, and panel member Democrat Bart Stupak, who chairs the panel’s oversight and investigations subcommittee, said that while the new restrictions on the use of actors and physicians address a problem which they raised with the industry group at the start of their probe into DTC advertising in May, the new code does not endorse a two-year prohibition on DRC ads for newly-approved drugs, as recommended by the Institute of Medicine (IoM), or deal adequately with other issues.

“On one hand, PhRMA has taken our Committee's concerns seriously by revising parts of their DTC code; on the other hand, some of these changes are merely a rewording of prior policy that does nothing to increase consumer protection,” said Rep Stupak. “Our investigation will continue, and we will be keeping a watchful eye on how well the industry follows these guidelines,” he added.

- The industry code now also includes new or revised elements covering: - the provision in DTC ads of the Food and Drug Administration’s (FDA) MedWatch phone number, or the company’s toll-free number, for reporting adverse drug events; - a requirement that companies should “consider” setting specific periods of time for education of health professionals prior to launching a DTC campaign for a new product or indication; - clarification that DTC ads should not promote medicines for off-label uses; - requiring companies to seek and consider feedback from healthcare professionals and consumers during the development of new DTC ad campaigns “to gauge the educational impact for patients and consumers”; - a requirement that television ads should direct consumers to print ads and/or web sites where they can find additional benefit and risk information; and - strengthened language calling for companies to include messages in DTC ads about help for the uninsured and underinsured.