Wednesday, December 10, 2008

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

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

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

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

"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.

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