FDA Unveils Plan To Combat Counterfeit Drugs

FDA on Wednesday released a report with proposals for the drug industry to combat counterfeit prescription drugs by voluntarily implementing new measures to help track and protect medications in the U.S. drug supply, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 2/19). The report was prepared by an FDA special task force in conjunction with drug manufacturers, wholesalers, retailers and pharmacy groups. The task force "gave a specific vote of confidence" to radio frequency identification systems and other electronic tracking technology, the Washington Post reports. Radio frequency identification systems use a chip containing information about where the drug was manufactured and where it was shipped. Additional information could be added to the chip each time the drug changes locations, and distributors and pharmacists could scan the ship to confirm the product is legitimate. The chip could be attached to drug labels or drug boxes or embedded in the drug. According to FDA Commissioner Mark McClellan, researchers are working to determine the effect of such chips on drugs' effectiveness and quality (Kaufman, Washington Post, 2/19). Electronic tracking is initially expected to cost as much as $1 per prescription, Cox/Contra Costa Times reports (Ackerman, Cox/Contra Costa Times, 2/19). The report also "indicate[s] that the agency intends to further delay" until December 2006 implementation of a current law requiring the drug industry to use a paper-based tracking system, the Los Angeles Times reports. According to the Los Angeles Times, the government anticipates that by then, most of the drug industry will have adopted electronic tracking systems (Kemper, Los Angeles Times, 2/19). McClellan said he does not support making such measures mandatory, but he added that drug manufacturers have "voiced a willingness to significantly upgrade their counterfeiting protections by 2007," according to the Post (Washington Post, 2/19).

The report also recommends the drug industry adopt labels printed with "high-tech ink," "hard-to-duplicate colors for pills and tablets" and chemicals that could be used to authenticate medication, according to the Dallas Morning News (Dodge, Dallas Morning News, 2/18). State governments should adopt stronger anti-counterfeiting laws, according to the report (Los Angeles Times, 2/19). Such efforts could include stricter regulation of drug wholesalers and greater security at drug distribution companies, according to the Fort Lauderdale Sun-Sentinel (LaMendola, Fort Lauderdale Sun-Sentinel, 2/19). The report also says that the federal government will seek tougher criminal penalties for those convicted of manufacturing or selling counterfeit medications. In addition, FDA plans to work to educate consumers and providers about the counterfeit drugs, according to HHS Secretary Tommy Thompson (Los Angeles Times, 2/19). The report says that FDA is working to create an alert network to quickly warn consumers and care providers about counterfeit medications (Wall Street Journal, 2/19).

According to Thompson, who released the report with McClellan, government investigations into counterfeit drug operations have increased from fewer than 10 per year in 2000 to more than 20 per year currently (Los Angeles Times, 2/19). McClellan said that up to 50% of the drug supply in some countries is counterfeit, the Post reports (Washington Post, 2/19). Thompson said, "We will take the necessary steps to protect all Americans from those who would exploit and harm them by selling counterfeit drugs" (Los Angeles Times, 2/19). "FDA will not rest until we have strong protections in each link of the drug supply chain, and we intend to work with all of those involved in getting medicines to Americans legally and safely to make sure that Americans are protected," McClellan said (Washington Post, 2/19). The Pharmaceutical Research and Manufacturers of America, the American Medical Association, the National Association of Boards of Pharmacy and other industry groups endorsed the report (Los Angeles Times, 2/19). Carmen Catizone, executive director of the NABP, said the federal government should mandate the recommended anti-counterfeiting measures, adding that "[v]oluntary just doesn't work in these areas" (Appleby, USA Today, 2/19). Dr. Sidney Wolfe, director of Public Citizen's health research group, questioned whether FDA's report is part of an effort to "bolster the Bush administration's opposition" to price controls on medicines and the reimportation of cheaper, U.S.-made drugs from Canada, the Morning News reports. "At a time when [the Bush administration is] mounting this campaign to stop the re-importation of drugs from Canada, it is interesting that this issue is being raised," he said (Dallas Morning News, 2/18). But McClellan said that FDA does not have the "legal authorities to provide effective oversight nor the resources" to ensure the safety of reimported drugs, adding, "When you go outside of [the U.S. drug] system, it really is, unfortunately, a 'buyer beware' situation. And this report does not provide the solution to that problem." Thompson noted that the new Medicare law requires HHS to complete a study of the reimportation issue (Los Angeles Times, 2/19).