The latest from OTC Perspectives

News from DTC Perspectives - PhRMA Announces Enhanced DTC Guidelines

PhRMA has revised its three-year-old Guiding Principles for DTC advertising, and will make the changes effective March 2, 2009. The trade association noted that the revisions are a response to “feedback from physician groups, policymakers and other stakeholders,” according to a press release posted Dec. 10 on its Web site. PhRMA’s revisions are an ongoing effort to continue the educational benefit of DTC, as well as to “renew our commitment to work with the Food and Drug Administration and healthcare professionals,” said Billy Tauzin, president and chief executive officer of the organization.

The revisions do not include any specified moratorium for consumer advertising of newly approved drugs, which many legislators in Washington have been advocating. Rather the new language specifies that companies should consider individually setting specific periods of time for education before launching a branded DTC campaign.

In addition, the updated guidelines note that PhRMA's Office of Accountability will continue to "collect comments about DTC advertisements and issue periodic reports to the public and FDA." While the Guiding Principles remain voluntary, the new guidelines state that "company CEOs and Compliance Officers will certify each year that they have processes in place to comply with the Principles." A list of all complying companies will be posted to the PhRMA Web site, including information about each company's annual certification status.

The revised Principles include the following enhancements: 

• A new principle states that DTC product advertisements featuring actors in the roles of healthcare professionals should identify that actors are being used. If actual healthcare professionals are featured and are compensated for their appearance, the advertisement should acknowledge the compensation.

 

• An added principle provides that DTC television or print advertisements featuring a celebrity endorser should accurately reflect the opinions, findings, beliefs or experience of the endorser. 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 highlights the legal requirement that DTC print advertisements should include FDA's MedWatch number for reporting of potential adverse events and DTC television advertisements should include the company's toll-free number or refer patients to a print advertisement that contains the MedWatch number.

 

• An existing principle regarding education of health professionals prior to a DTC campaign for a new medicine or indication is expanded to add that companies should consider individually setting specific periods of time for education before launching a branded DTC campaign.

 

• A revised principle includes language strengthening guidance related to the content and placement of DTC advertisements with adult-oriented content. Specifically, the new version 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 percent adults (18 years or older)."

 

• An existing requirement addressing risk-benefit balance in DTC advertising is strengthened to 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."

 

The press release also noted other revisions, such as: 

• "a clarification that companies should 'not promote medicines for off-label uses, including in DTC advertisements;'

 

• 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;'

 

• stating that in light of inherent limits on the amount of information that can be conveyed in a DTC television communications, television advertisements should direct consumers to print advertisements and / or Web sites where they can find additional benefit and risk information;

 

• strengthened language calling for companies to include messages about help for the uninsured and underinsured in DTC communications."