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U.S. Strikes Back Against Counterfeit Drugs

Officials launch multipronged attack to fight rise in illicit practice

WEDNESDAY, Feb. 18, 2004 (HealthDayNews) -- U.S. government officials today announced a comprehensive plan to combat counterfeit drugs.

"Drug counterfeiters not only defraud consumers but also deny ill patients the therapies that can alleviate suffering and save lives," Tommy Thompson, secretary of the Department of Health and Human Services, said at a press conference in Washington, D.C. He described drug counterfeiting as "a particularly insidious practice."

Dr. Mark McClellan, commissioner of the Food and Drug Administration, emphasized that the United States "has one of safest drug supplies in the world" but also pointed out that counterfeiting has been on the rise.

The number of counterfeit operations uncovered has risen from about 10 per year in 2000 to well over 20, McClellan said. "More and more of these counterfeiting operations involve finished drug products that look just like the real thing going to patients, rather than ingredients that might go to the manufacturer," he added.

Also, a growing number of illicit operations are spanning international borders, he said, noting the counterfeiting of Lipitor that occurred last year.

The new plan stems from a report -- Combating Counterfeit Drugs -- issued by the Counterfeit Drug Task Force, which was formed in July by the FDA to investigate the problem. The task force heard from security experts, technology developers, drug manufacturers and the general public.

The report was hailed by industry groups, including the American Society of Health-System Pharmacists, which will partner with the FDA in its initiative against counterfeiting.

"We are encouraged by the FDA's efforts to address this critical safety issue and eager to participate in this new initiative," the society's executive vice president and chief executive officer, Henri R. Manasse Jr., said in a statement.

"There is no single magic bullet to combat this threat," McClellan emphasized. "We need to be vigilant across the board in preventing counterfeiting."

The task force report puts forth a multipronged attack, which includes:

  • Implementation of new technologies to protect the drug supply. This would include "track and trace" technologies to monitor drugs from manufacturer to patient, expected to be available by 2007, McClellan said. Although costs are not yet low enough to make practices such as these universal, he was optimistic this would happen.
  • Use of "electronic pedigrees" instead of paper trails to ensure the legitimacy of drugs.
  • Adoption and enforcement of strong anticounterfeiting laws and regulations by the states. The FDA currently is working with the National Association of Boards of Pharmacy to devise model rules for licensing wholesale drug distributors.
  • Increased criminal penalties to deter counterfeiters. According to McClellan, the current criminal penalty for counterfeiting a label is up to 10 years in prison, but the penalty for counterfeiting the actual drug carries a maximum of three years. "The FDA has requested that the U.S. Sentencing Commission amend the guidelines," he said.
  • Adoption of secure business practices by all members of the drug supply chain. This would include ensuring the legitimacy of business partners and refusing to do business with partners of unknown or dubious background, McClellan said.
  • Development of an effective reporting system and strengthening of the FDA's response to these reports.
  • Education of consumers and health professionals about the risks of counterfeit drugs and how to protect against these risks.
  • Collaboration with foreign interests to develop strategies to deter and detect counterfeit drugs globally. "Counterfeit drugs are a global challenge today," McClellan said. "All of us around the world must work together." He said the FDA would work with the World Health Organization, Interpol and other international organizations to address counterfeit drugs.

"There is no one single technology or approach that we could enact and say we are confident that this will make the drug supply secure," McClellan says. "Counterfeiters are getting more sophisticated. We need to make sure we have the evolving tools to combat them."

More information

The FDA has the full Combating Counterfeit Drugs report. Or view the FDA's archive on counterfeit drugs.

SOURCES: Tommy G. Thompson, secretary, U.S. Department of Health and Human Services, Washington, D.C.; Mark B. McClellan, commissioner, U.S. Food and Drug Administration, Rockville, Md.; prepared statement, American Society of Health-System Pharmacists
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