THOUSAND OAKS, Calif., Aug 02, 2005 (BUSINESS WIRE) -- Amgen (NASDAQ:AMGN) today announced that it has become a
signatory to the pharmaceutical industry´s "Guiding Principles" on
direct-to-consumer (DTC) advertising. The Pharmaceutical Research and
Manufacturers of America (PhRMA) approved the Guiding Principles on
Friday, July 29, 2005 and they will go into effect in January 2006.
Amgen´s guidelines will go into effect by January 1, 2006.
These voluntary principles recognize the role DTC advertising of
prescription medicines can play by increasing awareness about
diseases, educating patients about treatment options, and motivating
patients to contact their physicians and engage in a dialogue about
"The intent of DTC advertising is to increase the likelihood that
patients will receive appropriate care for conditions that are
frequently under-diagnosed and under-treated," said George Morrow,
executive vice president, global commercial operations. "DTC is only
part of Amgen´s patient education effort. Amgen has long served
patients, physicians, and communities by supporting health education
programs singularly or with partnerships with patient advocacy groups
or health care providers."
PhRMA´s guidelines go beyond current Food and Drug Administration
(FDA) regulations. Principles that exceed FDA requirements include the
recommendation that manufacturers educate physicians about a
particular product before a new DTC campaign launches and the
commitment by companies to submit all new DTC television
advertisements to the FDA before releasing these advertisements for
broadcast. Amgen intends to expand its guidelines by pre-clearing
through the FDA all initial drug product DTC television and print
advertisements and to conduct DTC advertising only in categories where
there is significant under-diagnosis or under-treatment, an area where
DTC can make the most difference for patients.
The following are some of the key elements of PhRMA´s Guiding
To help achieve better consumer education, DTC ads designed to
market a drug should also responsibly educate patients about
the medicine and, when appropriate, the condition for which it
may be prescribed.
Before initiating a new DTC campaign for a newly approved
product, treating physicians and health care professionals
should be educated so they can effectively engage in
meaningful and balanced dialogue with patients. In determining
"an appropriate time," companies should consider the
importance of informing patients of the new medicine, the
complexity of its risk-benefit profile, and health care
professionals´ knowledge of the condition being treated.
Companies should continue to educate health care professionals
as additional valid information about a new medicine is
obtained from all reliable sources.
New DTC television ads should be submitted to the Food and
Drug Administration for review before they are aired.
DTC television and print advertising should be designed to
achieve a balanced presentation of the benefits and risks
associated with the advertised prescription medicine.
Specifically, risks and safety information in DTC television
advertising should be presented in clear, understandable
language, without distraction from the content, and in a
manner that supports the responsible dialogue between patients
and health care professionals.
DTC television advertising that identifies a product by name
should clearly state the health conditions for which the
medicine is approved and the major risks associated with the
medicine being advertised
Working with the FDA, companies should continue to responsibly
alter or discontinue a DTC advertising campaign should new and
reliable information indicate a serious previously unknown
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science´s promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis, and other serious illnesses.
With a broad and deep pipeline of potential new medicines, Amgen
remains committed to advancing science to dramatically improve
people´s lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below
and others that can be found in our Form 10-K for the year ended
December 31, 2004, and in our periodic reports on Form 10-Q and Form
8-K. Amgen is providing this information as of the date of this news
release and does not undertake any obligation to update any
forward-looking statements contained in this document as a result of
new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results
may differ materially from those we project. The Company´s results may
be affected by our ability to successfully market both new and
existing products domestically and internationally, sales growth of
recently launched products, difficulties or delays in manufacturing
our products, and regulatory developments (domestic or foreign)
involving current and future products and manufacturing facilities. In
addition, sales of our products are affected by reimbursement policies
imposed by first party payors, including governments, private
insurance plans and managed care providers, and may be affected by
domestic and international trends toward managed care and healthcare
cost containment as well as possible U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government regulations and
reimbursement policies may affect the development, usage and pricing
of our products. Furthermore, our research, testing, pricing,
marketing and other operations are subject to extensive regulation by
domestic and foreign government regulatory authorities. We, or others
could identify side effects or manufacturing problems with our
products after they are on the market. In addition, we compete with
other companies with respect to some of our marketed products as well
as for the discovery and development of new products. Discovery or
identification of new product candidates cannot be guaranteed and
movement from concept to product is uncertain; consequently, there can
be no guarantee that any particular product candidate will be
successful and become a commercial product. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors. Further,
some raw materials, medical devices, and component parts for our
products are supplied by sole first party suppliers.
Amgen, Thousand Oaks
Christine Cassiano, 805-447-4587 (Media)
Arvind Sood, 805-447-1060 (Investors)