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In late February 2012, the news media jumped on the discovery that fake copies of the cancer medicine Avastin were “circulating” in the U.S. The source of the fakes was determined to originate in “poor countries with lax regulations” according to an Associated Press article of February 28, 2012.[1] Because medicines and their ingredients continue to be manufactured overseas more cheaply than in the U.S., the U.S. Food and Drug Administration (FDA) and other government agencies are concerned that more fake drugs will make their way to the U.S. and place patients at risk. The news of the fake Avastin spurred cancer physicians, hospitals and clinics immediately to check their records.

Not only Avastin, but other widely used drugs, including Viagra, Lipitor and Alli, have been targets for manufacture of fakes. Connie Jung, FDA’s associate director of the Office of Drug Security, said in February that the FDA was aware that counterfeits are continuing to try and make their way onto the U.S. supply chain. A more recent CNN report, March 15, 2012, noted that the fake version of Avastin had been purchased by 19 hospitals and medical centers.

FDA’s Administrator Margaret Hamburg in a March 15 CNN interview claimed that it’s difficult for health care providers to know whether the drugs they are administering are fakes “because some of the fakes are very, very good.”[2] She said the investigation into the counterfeit medicines is ongoing and the situation served as “a wake-up call” that the FDA needed to work with the patient community and law enforcement to ensure that the US’ drug supply remains safe. Hamburg indicated she hoped legislation currently before Congress would pass to make it easier for FDA “to really track drugs in the system, and enable us to quickly pull inadequate drugs”.[3] Testimony before Congress as far back as 2005 by then-Acting Associate Commissioner FDA, Randall Lutter, stated, “U.S. law defines counterfeit drugs as those sold under a product name without proper authorization, where the identity of the source of the drug is knowingly and intentionally mislabeled in a way that suggests that it is the authentic approved product.”[4] The term “counterfeit” can apply to several categories of drugs, including brand name drugs, generics, and bulk ingredients.

There is concern that the ongoing shortage of many drugs, including cancer drugs, may give counterfeit suppliers a greater incentive to try to move bogus drugs into the country. Hamburg hopes the legislation before Congress will give FDA and law enforcement the power to seize fakes upon their attempted entry into the US and enable the FDA to work with law enforcement in other countries to track the sources of counterfeit drugs. In mid-March, the U.S. Senate unanimously passed S. 1886, the Counterfeit Drug Penalty Enhancement Act, which increases penalties for trafficking counterfeit drugs. If passed in the House, the law will aim at violators who knowingly manufacture, sell, or traffic counterfeit medicines in the United States. The status as of March 28, Subcommittee hearings had been held in the U.S. House of Representatives on a House version of the bill, H.R. 3668.

This bill needs to be enacted and enforced.

[1] “Invasion Of The Fakes: Big Bucks May Be Drawing Counterfeit Medicines Into U.S.,” Associated Press, The Daily News Record, February 16, 2012, p. A10.

[2] FDA Commissioner Margaret Hamburg Talks Counterfeit Drugs, CNN Interview by Caleb Hellerman, March 15, 2012,,

[3] Op. Cit.

[4] Statement of Randall W. Lutter, Ph.D., Acting Associate Commissioner of Policy and Planning, Before Congress, November 1, 2005, Food and Drug Administration, Washington, D.C.

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