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The FDA Commends Drug Industry Commitment to Report Counterfeit Drugs

ROCKVILLE, MD -- April 22, 2003 -- The Food and Drug Administration commends the Pharmaceutical Research and Manufacturing Association (PhRMA), the nation's largest representative of the drug industry, for its commitment to actively help FDA identify and remove counterfeit drugs from the United States market.

The commitment, which was announced by PhRMA's board of directors, obligates member companies to "notify FDA's Office of Criminal Investigations, by telephone or in writing, within five working days of determining that there is a reasonable basis to believe their product has been counterfeited."

"This action adds to our tools for protecting the public against counterfeit drugs," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "The FDA works with local, state, and federal law enforcement authorities to protect Americans from the health risks of bogus drugs. PhRMA's members already assist in these efforts by actively investigating credible reports about the distribution of counterfeit drugs. This formal collaborative agreement will strengthen the FDA's ability to assure the safety and effectiveness of drugs used by Americans."

The quality of drugs in this country is very high, giving the public confidence that the drugs they buy in the United States are authentic.

Currently when the Agency gets a report of a counterfeit drug, first and foremost, the FDA works with consumers, manufacturers, wholesalers, distributors, state agencies and others to determine the composition of the unsuitable product and the extent to which it has been introduced into the distribution chain. This allows the Agency and others to take steps that will minimize the public's exposure to counterfeit drugs.

Moreover, the additional pledge of PhRMA's more than 60 member companies to report such verified incidents to the FDA in a timely fashion will further help the agency to take swift enforcement actions, when necessary, to protect the public health.

As the drug manufacturing and distribution system has become more global in nature and as health care costs have increased, protecting against counterfeit, adulterated or substandard drugs has become more challenging. Thus it is important that members of the drug distribution chain follow the lead of the pharmaceutical industry to work in a proactive collaborative fashion with the FDA to address this problem.

PhRMA's voluntary program to report counterfeit drugs to the FDA is scheduled to begin on May 1st, 2003. Both the FDA and PhRMA will assess the value of this program at the end of one year.

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