PhRMA Revises DTC Guidelines

[Pharma Newshound]

Source: PhRMA Press Release

America’s Pharmaceutical Research Companies Enhance
Voluntary Guidelines on Direct-to-Consumer Advertising

Washington, D.C. (December 10, 2008) — Affirming its commitment to responsible direct-to-consumer (DTC) advertising that benefits public health, the Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors has adopted measures to strengthen the PhRMA Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines.

PhRMA’s voluntary Guiding Principles, which originally went into effect in January 2006, provide guidance to pharmaceutical research and biotechnology companies on ways to ensure that DTC communications provide accurate, accessible and useful information to patients and consumers.

In numerous studies and surveys, DTC advertising has been shown 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 such as diabetes, hypertension and depression, benefiting not only individual patients but the entire healthcare system.

Reflecting feedback from physician groups, policymakers and other stakeholders, the revised Guiding Principles are part of an ongoing effort to enhance the educational potential of DTC communications, while maintaining respect for the patient-provider relationship. Generally, the revised Principles address aspects of DTC ranging from healthcare professionals and celebrities featured in advertisements, to presentation of balanced benefit and risk information, to the appropriate timing and placement of advertisements with adult-oriented content.

“Pharmaceutical research companies for years have voluntarily exceeded regulatory requirements for direct-to-consumer advertising of prescription medicines,” said PhRMA President and CEO Billy Tauzin. “Our Guiding Principles help ensure that DTC advertising appropriately and accurately conveys important information about medical conditions, medicines and other treatment options.”

“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,” added Tauzin.

The revised Principles, which take effect March 2, 2009, 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.”

Other revisions to the Guiding Principles include: a clarification that companies should “not promote medicines for off-label uses, including in DTC advertisements”; a revised principle 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 revised principle 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; and strengthened language calling for companies to include messages about help for the uninsured and underinsured in DTC communications.

As with the original version, the revised Principles envision that PhRMA’s Office of Accountability will collect comments about DTC advertisements and issue periodic reports to the public and FDA. In addition, recognizing that there is room for enhanced public accountability for DTC advertising, the new Guiding Principles provide that company CEOs and Compliance Officers will certify each year that they have processes in place to comply with the Principles. PhRMA will post on its web site a list of all companies that announce their pledge to follow the Principles and information about the status of companies’ annual certifications.

Find Guidelines here.