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Amgen Adopts ``Guiding Principles'' for Direct-to-Consumer Advertising
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 health concerns.
"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 Principles:
- 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 safety risk.
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)