PhRMA Revises Principles for DTC Ads

Washington, DC (Dec. 10)-The Pharmaceutical Research and Manufacturers of America (PhRMA) adopted measures to strengthen its Guiding Principles for Direct to Consumer (DTC) Advertisements about Prescription Medicines. The revised principles address subjects such as healthcare professionals and celebrities featured in advertisements, the presentation of balanced benefit and risk information, and the appropriate timing and placement of advertisements with adult-oriented content.

The revised principles will take effect on Mar. 2, 2009 and include the following changes:

• A new principle states that DTC product advertisements that feature actors in the roles of healthcare professionals should declare that actors are being used. Advertisements also should acknowledge when featured healthcare professionals are compensated for their appearances.

• An added principle states that DTC television or print advertisements that feature a celebrity endorser should accurately reflect his or her opinions, findings, beliefs, or experience. Companies should maintain verification of the basis of any actual or implied endorsement, including whether the endorser is or has been a user of the product.

• A new principle emphasizes the legal requirement that DTC print advertisements should include the US Food and Drug Administration’s MedWatch number for reporting potential adverse events. The principle also states that DTC television advertisements should include the company’s toll-free number or refer patients to a print advertisement that contains the MedWatch number.

• A revised principle specifically states that DTC television or print advertisements “containing content that may be inappropriate for children” should be placed in programs or publications “reasonably expected to draw an audience of approximately 90% adults (18 years or older).”

• An existing requirement for risk–benefit balance in DTC advertising will specify that risks 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 distraction from the content.”

Other revisions include a clarification that companies should “not promote medicines for off-label uses, including in DTC advertisements,” a principle requiring companies to seek and consider feedback from healthcare professionals and consumers during the development of new DTC ad campaigns, a principle stating that television advertisements should direct consumers to print advertisements or websites for additional benefit and risk information, and strengthened language calling for companies to include messages about help for the uninsured and underinsured in DTC communications.

“Through these strengthened Principles, we renew our commitment to work with the Food and Drug Administration and healthcare professionals to further enhance the value of balanced DTC education for consumers and patients,” said Billy Tauzin, president and chief executive officer (CEO) of PhRMA, in a press release.

The revised Guiding Principles reflect feedback from physician groups, policymakers, and other stakeholders, according to the press release. PhRMA’s voluntary Guiding Principles originally went into effect in January 2006 and are intended to help pharmaceutical research and biotechnology companies ensure that DTC communications provide accurate, accessible, and useful information to patients and consumers.

PhRMA’s Office of Accountability will continue to collect comments about DTC advertisements and issue periodic reports to the public and FDA. In addition, the new Guiding Principles state that company CEOs and compliance officers will confirm annually that they have processes in place to comply with the Principles. PhRMA will post a list of all companies that pledge to follow the Principles and information about companies’ annual certifications on its website.

Reps. John D. Dingell (D-MI), chairman of the House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, praised PhRMA for the revisions. In a press release, however, the legislators noted that the revisions do not include certain recommendations.

The principles do not state that valid clinical-outcomes studies of drugs must be complete before the drug is advertised. In addition, the principles do not call for FDA’s MedWatch number to be included in all DTC television ads. Also, the new code does not endorse the Institute of Medicine’s recommendation for a two-year prohibition on DTC ads for newly approved drugs.

“I commend PhRMA on taking our investigation seriously,” said Dingell. “Although this revision is the first step toward protecting American consumers, there is much more that can be done. We look forward to working with PhRMA to add further consumer protections into their policies.”

For more more about this topic, see:“FTC Seeks to Revise Use of Ad-Based Endorsements and Testimonials” and “Lawmakers Question FDA About DTC Website.”