San Francisco Chronicle - June 10, 2006
Victoria Colliver, vcolliver@sfchronicle.com.

The government has long delayed enacting the rules, which were approved in 1987, because of questions about which technologies to use and fears that tracking laws would put some wholesalers out of business. But improved technologies and efforts by states, including California, to curb counterfeiting prompted the FDA to act.

"The states are moving forward ... and we're committed to minimizing opportunities for counterfeiters and diverters to infiltrate our nation's drug supply with counterfeit drugs," Randall Lutter, FDA associate commissioner for policy planning, said in a conference call.

While FDA officials said the prevalence of bogus drugs is low, they acknowledged drug counterfeiters are becoming increasingly sophisticated. The FDA's Office of Criminal Investigations opened 32 counterfeiting cases last fiscal year and 58 in fiscal 2004, compared with fewer than 10 cases a year five years earlier.

Some of the most commonly counterfeited drugs are Viagra and Cialis for erectile dysfunction, the antipsychotic drug Zyprexa, Lamisil for nail fungus and Procrit, which is often used by cancer and AIDS patients to treat anemia, according to the FDA.

After a drug is manufactured, it can go through a complex maze of wholesalers and secondary wholesalers before it reaches a pharmacy. Fake or stolen drugs can get into the system through a careless or unscrupulous wholesaler. With no clear tracking records, it's difficult for authorities to identify where counterfeit products were introduced in the chain.

The FDA said radio-frequency identification technology is a promising way to electronically maintain a so-called pedigree, a record that tracks drugs' chain of ownership. The rule going into effect in December would allow paper and electronic documentation.

The California Board of Pharmacy supported the FDA's announcement but said the state has already passed pedigree requirements that are stricter than what the federal government has approved.

"At least it's setting the standard for 50 states," said Patricia Harris, executive officer of the state Board of Pharmacy. "The concern is it's different from our law."

California's law, which is scheduled to go into effect in 2007 but will probably be delayed until 2008, requires electronic documentation every time a drug changes hands. The federal law also allows manufacturers to designate authorized wholesalers that are exempt from pedigree requirements.

San Francisco's McKesson Corp., a health services company and one of the country's largest drug wholesalers, supported the FDA's actions. McKesson buys drugs directly from manufacturers.

"We have been not only a strong proponent (of tracking requirements), but very active in a major projects to drive toward the use of serialization in RFID technology to secure the supply chain," Kate Rohrbach, McKesson spokeswoman, said.

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The Associated Press contributed to this report.

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