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DOJ Announcement

21st Apr 2005 06:00

Pfizer Says Sale of Illegal and Unapproved Drugs Is Growing Threat to U.S. Patients; Applauds Announcement by Department of Justice NEW YORK, April 21 -- A crackdown on international sales of illegal and unapproved pharmaceutical products announced today by the U.S. Department of Justice highlights the growing challenge of maintaining a safe and secure drug distribution system, said Jeff Kindler, Pfizer's vice chairman and general counsel. The federal agency reported that it has arrested 16 suspects and seized more than $6 million as part of a multi-country effort to address drug counterfeiting and the trafficking of illegal and unapproved pharmaceutical products over the internet. "Today's announcement is a major step forward in protecting U.S. consumers from potentially harmful products," Kindler said. "More and more often we're seeing counterfeit or otherwise illegal medicines reaching unsuspecting patients. It's becoming a real threat to public health that could become an even greater problem if legislation is passed supporting the importation of pharmaceutical products from other countries." Kindler said unapproved or illegal drugs are increasingly entering the legitimate pharmaceutical distribution system or being sold over the internet without a doctor's prescription or oversight. These drugs may be manufactured in unregulated settings that do not adhere to the rigorous standards required by the FDA. They may be contaminated, stored improperly, outdated, may not work as claimed, may contain potentially dangerous ingredients, or have no beneficial effect at all. Pfizer has learned from its own investigations that consumers may even receive medications that they didn't order. Kindler said legalizing importation will not make the system safer. It will only exacerbate existing problems by significantly weakening the FDA's ability to safely regulate pharmaceuticals entering the U.S. from other countries. Predicted cost savings would not be realized due to the dramatically increased expense of enforcement, he added. "The sale of illegal and unapproved drugs is a high profit, low risk enterprise that is attracting criminals who have no regard for the patients who are buying their products," Kindler pointed out. "It's important that government and industry work together to aggressively address what is becoming a very serious health issue. The United States is known for having one of the safest drug distribution systems in the world and we must make sure it stays that way." Pfizer has led the pharmaceutical industry in addressing counterfeiting and the sale of illegal and unapproved drugs. Its efforts have included: Ongoing * Initiation of legal action against illegitimate online "pharmacies" and cooperation with law enforcement agencies to block sales of counterfeit Pfizer products. * Coordination with government, law enforcement and other agencies to halt the importation of pharmaceutical products and to seize those products. * Implementation of public education programs to inform consumers about safely purchasing medicines over the internet. * Promotion of internet purchases from Verified Internet Pharmacy Practice Sites(TM) (VIPPS(R)), which are certified by the National Association of Boards of Pharmacy(R) (NABP(R)). * Testing of hundreds of products annually to determine their authenticity. February 2005 * Partnered with Microsoft Corp. to file parallel lawsuits against international pharmacy spam rings operating websites that sell, without a prescription, illegal "generic" versions of Viagra as well as controlled substances. The two companies filed 17 new actions against defendants involved in the sale and advertising of potentially dangerous medications. * Filed civil actions against two websites that allegedly promote and sell products that are unapproved by the FDA. Pfizer also filed 10 other domain name actions. November 2004 * Introduced a new initiative, which uses radio frequency identification (RFID) tags that will enable wholesalers and pharmacies to authenticate all Viagra sold in the United States. * Worked with several organizations and industry groups to develop standards and procedures for implementing RFID and the systems required to support it. September 2004 * Filed legal action against 18 internet sites for selling unapproved and illegal copies of Pfizer's leading cholesterol medicine, Lipitor. August 2004 * Filed 25 Uniform Domain Name Dispute Resolution Policy (UDRP) actions against domain names using Pfizer's Viagra trademark in an unauthorized manner to sell products that have not been approved by the FDA. Sites shut down and domains were transferred to Pfizer. * Launched an online public awareness advertising campaign and resource section on http://www.viagra.com to help educate consumers about how to avoid illegitimate websites, safely purchase genuine Viagra online, and help minimize Viagra spam. June 2004 * Announced the introduction of new security packaging for Viagra(R) labels, which contained a color-shift Pfizer logo in the lower left- hand corner of the label's center panel that changes between purple and blue when examined from various angles. May 2004 * Announced the signing of a memorandum of understanding with the Shanghai, China, Municipal Food and Drug Administration through which the company will provide specialized drug authentication and anti-counterfeiting training. The program will prepare officers to identify counterfeit pharmaceutical products and shut down operations where they are manufactured. China is recognized as the world's leading supplier of counterfeit drugs. December 2003 * Placed new requirements on Pfizer's authorized wholesalers and distributors preventing them from purchasing Pfizer medicines on the secondary market, which has been a primary avenue for counterfeit products entering the U.S. distribution system. * Signed a memorandum of understanding with the Shanghai, China, Administration for Industry and Commerce to provide drug authentication and anti-counterfeiting training. SOURCE Pfizer Inc 04/21/2005 /CONTACT: Bryant Haskins of Pfizer Inc, +1-212-733-8719/ /Company News On-Call: Pfizer's press releases are available through PR Newswire's Company News On-Call service on PRN's Web Site. Visit http://www.prnewswire.com/comp/688250.html / /Photo: A free corporate logo to accompany this story is available immediately via Wieck Photo Database to any media with telephoto receiver or electronic darkroom, PC or Macintosh, that can accept overhead transmissions. To retrieve a logo, please call 972-392-0888./ /Company News On-Call: http://www.prnewswire.com/comp/688250.html / /Web site: http://www.pfizer.com / (PFE) ENDPFIZER INC

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