Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
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Wall Street Journal - July 17, 2003
Leila Abboud, Staff Reporter of The Wall Street Journal
FDA Commissioner Mark McClellan said that to combat fakes, the agency will consider use of high-technology packaging, closing gaps in the distribution system and levying stiffer penalties on counterfeiters. Dr. McClellan said an agency task force will release an initial report in two months, with final findings due in six months.
"The dangers posed by counterfeit drugs are real, and we intend to make sure that [they remain] a very limited threat to our citizens," Dr. McClellan said.
Last month, fakes of the top-selling cholesterol drug Lipitor got onto the U.S. market. So far, 200,000 bottles of the bogus Lipitor have been recalled by distributors. The FDA is investigating the case as a criminal matter. Dr. McClellan said early results from the investigation showed that the fake Lipitor came from outside the country and were repackaged in the U.S. Eleven million Americans take Lipitor a year, says Pfizer Inc., the drug's manufacturer.
While the FDA said no deaths have been linked to fake drugs in recent years, many adverse events go unreported. Some fakes can be too potent. Others have no active ingredients.
Fake versions of the big-selling Johnson & Johnson anemia drug, Procrit, made it to patient's hands in 2001. Bacteria-contaminated water was passed off as the treatment, which is usually prescribed for cancer and AIDS patients with anemia.
The FDA assured the public that counterfeit drugs remain rare. But the agency is seeing more fakes lately, and investigations are rising from about five a year in the late 1990s to more than 20 a year since 2000. It is also concerned that more fakes are now finished drugs, as opposed to bulk ingredients, which used to be the preferred target for counterfeiters. The FDA says computer technology has made fake packaging and labels very hard to distinguish from the real thing.
The FDA's new effort highlights one of the main arguments the drug industry has made in opposing efforts by Congress to legalize importation of prescription drugs from Canada and elsewhere. That debate is now raging because some lawmakers are pushing to insert a provision to the Medicare bill to lift restrictions on imported drugs, hoping to save consumers money on their drug bills. The FDA and the Health and Human Services Department have long opposed such a move because, they say, the safety of imported drugs couldn't be assured.
The FDA plans to do a study at points of entry to gauge the levels of imported drugs and whether fakes are a problem.
The drug distribution system in the U.S. has weaknesses that counterfeiters exploit. Drugs don't go straight from manufacturers to pharmacies and patients. Instead, wholesalers act as intermediaries, in primary and secondary markets.
Some 90% of drugs go through three large wholesalers, AmerisourceBergen Corp., Cardinal Health Inc., and McKesson Corp. This is called the primary market. When the big wholesalers sell off excess stock to smaller wholesalers, that forms a secondary market.
The 7,000 smaller wholesalers in the secondary market are the weak link in the drug-distribution chain. These secondary wholesalers can end up buying fake drugs from unscrupulous brokers and then distributing them.
"They seem to be the entry point for counterfeit drugs," said Thomas McGinnis, the FDA's associate director of pharmacy affairs. Once in distribution, fake drugs have ended up in major chain pharmacies, Mr. McGinnis said.
Write to Leila Abboud at leila.abboud@wsj.com
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