21 January 2004

New FDA Initiative to Combat Counterfeit Drugs

New FDA Initiative to Combat Counterfeit Drugs:

In an effort to protect against the rising occurrence of potentially unsafe counterfeit drugs reaching consumers, FDA is announcing a new initiative to more aggressively protect American consumers from the risks posed by counterfeit drugs. As part of this effort, FDA has created a new internal task force that will develop recommendations for steps FDA, other government agencies, and the private sector can take to minimize the risks to the public from counterfeit drugs getting into the supply chain.

Background on Counterfeit Drugs
Risks of Counterfeit Drugs

Counterfeit drugs pose potentially serious public health and safety concerns. They may contain only inactive ingredients, incorrect ingredients, improper dosages, or even dangerous sub-potent or super-potent ingredients. Drug counterfeiting is a relatively rare event in this country; however, FDA has seen its counterfeit drug investigations increase to over 20 per year since 2000, after averaging only about 5 per year through the late 1990s.

In addition, counterfeiting in recent years has shifted increasingly into “finished” pharmaceuticals (the final product taken by the patient) as opposed to counterfeiting of “bulk” drug ingredients in the past. As drug manufacturing and the distribution system have become more complex, there are increased opportunities to introduce more legitimate appearing products into the drug supply in the U.S., and the challenge of protecting against unsafe counterfeit drugs has become more difficult.

Counterfeit drugs entering the U.S. distribution supply chain can find their way into the system through the secondary wholesale market, where drugs can change hands several times before reaching the end user. Such drugs can also enter the U.S. market via disguised imports from other countries, or through the purchase by American consumers of drugs through the internet.

Engage Private Sector Stakeholders.

The task force will gather private sector information and collaborate with pharmacy and health professionals, drugs manufacturers and distributors, consumer organizations, and other stakeholders on how to best counter these criminal practices.

Engage Other Government Agencies.

The task force will improve coordination with other government agencies, including the U.S. Customs and Border Protection Service, the Treasury Department, the Department of Justice, and States, who have experience with counterfeiting.

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