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Amgen Adopts ``Guiding Principles'' for Direct-to-Consumer Advertising.


THOUSAND OAKS Thousand Oaks, residential city (1990 pop. 104,352), Ventura co., S Calif., in a farm area; inc. 1964. Avocados, citrus, vegetables, strawberries, and nursery products are grown. , Calif. -- Amgen (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:AMGN) today announced that it has become a signatory sig·na·to·ry  
adj.
Bound by signed agreement: the signatory parties to a contract.

n. pl. sig·na·to·ries
One that has signed a treaty or other document.
 to the pharmaceutical industry's "Guiding Principles" on direct-to-consumer (DTC DTC

See: Depository Transfer Check


DTC

See: Depository Trust Company


DTC

See Depository Trust Company (DTC).
) advertising. The Pharmaceutical Research and Manufacturers of America Pharmaceutical Research and Manufacturers of America (PhRMA) is an industry trade group representing the pharmaceutical research and biotechnology companies in the United States.  (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 George Morrow can refer to:
  • George Morrow (cricketer), Irish
  • George Morrow (computers), developed the S-100 bus
  • George Morrow (bassist), with Max Roach
  • George Morrow (basketball player), in the National Basketball League (Australia)
, 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 Patient advocacy refers to speaking on behalf of a patient in order to protect their rights and help them obtain needed information and services. The role of patient advocate is frequently assumed by nurses, social workers, and other healthcare providers.  groups or health care providers."

PhRMA's guidelines go beyond current Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 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.

About Amgen

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 Kidney Disease Definition

Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease.
, rheumatoid arthritis rheumatoid arthritis

Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course.
, 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.

Forward-Looking Statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 

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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2004, and in our periodic reports on Form 10-Q Form 10-Q

See 10-Q.
 and Form 8-K Form 8-K

The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock.


Form 8-K

See 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 cost containment,
n the features of a dental benefits program or of the administration of the program designed to reduce or eliminate certain charges to the plan.
 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 Side effects

Effects of a proposed project on other parts of the firm.
 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 in·val·i·date  
tr.v. in·val·i·dat·ed, in·val·i·dat·ing, in·val·i·dates
To make invalid; nullify.



in·val
 or circumvented by our competitors. Further, some raw materials, medical devices, and component parts for our products are supplied by sole first party suppliers.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Geographic Code:1USA
Date:Aug 2, 2005
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