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:
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)