FDA Finds Problems in Reimported Drugs

October 4, 2004
Federal officials say 439 packages of prescription drugs purportedly exported from Canada and intercepted by U.S. Customs and Border Protection officials in Miami were not manufactured in the United States and had been subject to Canadian recall.

The drugs were ordered by U.S. residents through CanadaRx.com, a Hamilton, Ontario-based mail-order pharmacy, and were seized in July, the Boston Globe reported. In September, the intended recipients were informed that they must register a complaint with the agency to reclaim their prescriptions.

CanadaRx is the main pharmacy for the Canadian Prescription Drug Importation Program, a program sponsored by the Minnesota Senior Federation that serves about 6,000 Minnesota seniors.

The intercepted drugs were shipped from Britain, Canada, Germany, Switzerland, France, Australia and New Zealand. CanadaRx apparently shipped the prescription drugs through Freeport, Grand Bahama, to Miami for distribution in the United States.

In recent months, some U.S. pharmaceutical companies have attempted to limit the supply of drugs to Canada to stop the cross-border trade, leading the Canadian companies to look to other countries for supplies.

The Food and Drug Administration said that some of the intercepted drugs appeared to have been made in Singapore, Japan and New Zealand, and several packages "had unstated dosages and suspicious labels."

Of the intercepted drugs, 50% had lower-cost generic equivalents available in the United States, according to FDA Associate Commissioner for Policy and Planning William Hubbard. In a letter sent to Rep. Bernard Sanders (I-Vt.) and four other members of Congress, Hubbard said, "what we're trying to paint in this letter is a series of ... abnormalities."

FDA officials also said CanadaRx opened the division in the Bahamas "to evade regulation" by U.S. or Canadian authorities, the Globe said.

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