FDA Takes War Against Fake Meds Online

Jun 18, 2008
By Pharmaceutical Executive Editors

FDA announced on Tuesday that it will go on the offensive against online pharmaceutical dealers selling fraudulent cancer products. The agency told reporters that it has sent 25 warning letters to companies actively marketing and selling drugs that have not been approved for treatment. A spokesperson said that the drugs in question could interfere with medication a patient is already taking, or could be used to forgo medically accepted treatment plans.

"Health fraud has been around for years, and it is a cruel form of greed," said David Elder, director, Office of Enforcement, Office of Regulatory Affairs, FDA. "Fraud involving cancer treatments can be especially heartless."

The warning letters related to approximately 125 unapproved products that are being touted as a cure, treatment, or prevention for cancer. FDA is listing red flags to help consumers spot fraudulent Web sites and pharmaceutical scammers.

"FDA is concerned that these products have not been through the FDA drug approval process, and lack evidence of safety and effectiveness," said Michael Levy, director, New Drugs and Labeling Compliance division, FDA. "In addition, these products pose either a direct health risk to consumers or a serious indirect health risk because they are marketed for a serious disease—in this case cancer."

The agency said that no adverse events have been reported from the drugs in question, and it is sending the letters in order to be proactive against the potential for health risks. Levy noted that one particular treatment for skin cancer actually burns away healthy skin, leaving severe scars.

According to FDA, some of the online drug sellers in question have already responded and pulled products.

This effort was born out of a North American collaboration between Mexico, Canada, and the US, which targets a different, particular area of concern each year. Last year, the agency targeted diabetes fraud, and before that it went after weight loss scams.

"Are we ever going to eliminate health fraud from this country?" Levy asked. "It's going to be difficult, particularly now more so than a hundred years ago, due to the growth of the Internet and the ease of marketing products with various claims."

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