FDA Task Force Outlines Proposal To Combat Counterfeit Medications
The FDA Counterfeit Drug Task Force on Thursday unveiled a draft report on potential measures to combat counterfeit drugs in the United States, a move that could "broadly reshape how medicines are packaged and distributed," the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 10/3). The issue of counterfeit drugs has "become more urgent" because of a spike in the number of reported cases -- from about five per year through the late 1990s to more than 20 per year beginning in 2000, the New York Times reports (Grady, New York Times, 10/3). FDA officials said that investigations found "well-organized groups, including some that distribute illegal drugs," are attempting to make a profit from selling counterfeit drugs, Reuters/Philadelphia Inquirer reports (Richwine, Reuters/Philadelphia Inquirer, 10/3). FDA Commissioner Dr. Mark McClellan said that counterfeiting technology "is getting better, opportunities are there [for counterfeiters]," adding, "This is where the dollars are ... where organized crime is being attracted because of the opportunities" (Schwab, Newark Star-Ledger, 10/3).
The draft report says that a variety of anti-counterfeiting measures need to be implemented throughout the U.S. drug distribution system for the United States to "stay a step ahead of criminals," Reuters/Inquirer reports (Reuters/Philadelphia Inquirer, 10/3). Suggested steps include:
- Requiring drug companies to use "unit of use" packaging instead of bulk shipments of drugs, which are now sent to repackagers for bottling and labeling;
- Requiring tamper-evident packaging that would include at least two anti-counterfeiting technologies, such as radio-frequency emitting microchips, micro-bar-code tags, color-shifting inks, special perfumes or embedded threads (New York Times, 10/3);
- Limiting the number of times that the drugs that are most commonly counterfeited are sold in the distribution system (Wall Street Journal, 10/3); and
- Reinstituting a rule postponed in 1999 that requires a complete "paper pedigree" of every sale of a drug between makers and distributors.
Despite an increase in counterfeit drug activity, McClellan said that less than 1% of prescription drugs on the U.S. market are counterfeit and that consumers who buy drugs at legitimate drugstores have "little to worry about," the Times reports. Dr. Alan Goldhammer, vice president of the Pharmaceutical Research and Manufacturers of America, called the report "very positive," adding, "A key point is similar to our own assessment, that there is no single solution, no magic bullet" (New York Times, 10/3). Goldhammer said that drug packaging requirements must "allow flexibility" (Wall Street Journal, 10/3). McClellan emphasized that counterfeiting is "a separate issue from" reimportation and debates over the safety of reimported drugs, the Times reports (New York Times, 10/3). However, CongressDaily reports that FDA officials released the draft report with the hopes that it will "dampen enthusiasm on Capitol Hill and elsewhere" to reimport drugs from Canada and other industrialized nations (CongressDaily, 10/2). McClellan said that anti-counterfeiting technologies could not protect U.S. consumers from the risks of reimporting drugs because the FDA does not have the authority to regulate such drugs (Reuters/Philadelphia Inquirer, 10/3). Reimported drugs present "other buyer-beware challenges," he said (CongressDaily, 10/2). The draft report is available online. The New York Times on Friday looks at how consumers can protect themselves against counterfeit drugs (O'Connor, New York Times, 10/3).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.