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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P04-13
February 4, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

FDA and Johnson & Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site

FDA and Johnson & Johnson of Raritan, NJ are warning the public about an overseas internet site selling counterfeit contraceptive patches that contain no active ingredients. These counterfeit patches provide no protection against pregnancy.

This internet site's domain name, www.rxpharmacy.ws apparently is operated by American Style Products of New Delhi, India. The site also sells other products that purport to be versions of FDA-approved drugs. FDA is investigating these other products as well, and urges consumers to treat any drugs purchased from this firm as being suspect. None of these products should be considered safe or effective. Consumers who have any of these products should not use them, but instead contact their healthcare providers immediately.

"FDA will continue to do all it can to protect Americans from unsafe and counterfeit drugs purchased from illegal foreign sites," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "This case highlights the serious risks posed by foreign drug operations that bypass FDA safeguards. People are risking their health, in some cases their very lives, by buying illegal internet drugs."

To protect the public health FDA has obtained the cooperation of the U.S.-based internet service provider in shutting down service to this site.

The counterfeit contraceptive patches were promoted as Ortho Evra transdermal patches, which are FDA approved, and made by Johnson & Johnson's Ortho-McNeil Pharmaceutical, Inc. subsidiary.

Instead customers receive packages of patches without the active ingredient necessary to make the patches effective. Moreover, the counterfeits are sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dating or any other labeling information needed to safely and effectively use this prescription product.

The FDA-approved Ortho Evra contraceptive patch is an adhesive patch that contains a combination of an estrogen and a progestin for contraception. The patch is applied to the skin of a woman's abdomen, upper outer arm, upper torso or buttock for seven days. A new patch is applied each week for three weeks (21 total days), followed by one patch-free week.

The FDA-approved patch product is 1¾ inches square, beige in color, made of a thin film, and comes packaged in a sealed, opaque, white pouch with the product label attached to one side of the pouch. The lot number and expiration date for the product are printed on the attached label and on the back side of the pouch without the attached label.

The counterfeit product is 1½ inches square, brown in color, made of woven material, and has 5 holes that appear as red dots on the middle of the top side of the patch. This product also has a ¾ inch orange square resembling gauze under the plastic liner on the back side of the patch. The product does not come packaged in a sealed pouch and does not contain lot number or expiration date information.

Photos contrasting the legitimate contraceptive patch with the counterfeit are on display at the FDA's website: http://www.fda.gov/bbs/topics/news/photos/contraceptive/counterfeit.html

Women who have been sent contraceptive patches lacking proper labeling or not having the appearance of the approved Johnson & Johnson Ortho Evra product as described above should not use the product and should contact their healthcare providers immediately.

FDA's Office of Criminal Investigation is working with Johnson & Johnson and the Department of Homeland Security's Bureau of Immigration and Custom Enforcement's (ICE) Cyber Crimes Center to combat counterfeiting and other illegal internet drug sales and take effective action against those responsible. Trafficking in counterfeit, unapproved adulterated, or misbranded products is a felony violation of the Federal Food Drug, and Cosmetic Act. FDA is particularly grateful for the expeditious assistance in this matter provided by the ICE Cyber Crimes Center. The criminal investigation is ongoing.

To date no reports of pregnancies linked to this product have been received by FDA and distribution of the counterfeit products appears limited to this internet site.

Consumers seeking to buy safe and effective drugs via the internet should only purchase from internet sites bearing the Verified Internet Pharmacy Practice Sites (VIPPS) seal showing that they are in accordance with the National Boards of Pharmacy standards.

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