FDA Tells Mail-Order Pharmacy to Stop Supplying Drugs to Mass. City

BETHESDA, MD, 17 September 2003 — On the same day that Springfield, Mass., Mayor Michael J. Albano met with officials from the Food and Drug Administration (FDA) to defend his employee program of purchasing drugs from Canada, the agency warned the mail-order company supplying the drugs that its activities run afoul of U.S. law.

FDA yesterday issued a warning letter to CanaRx Services Inc. of Detroit and told the company that its operations were "illegal and a risk to public health."

The company is one of many that FDA has recently warned about activities related to illegal importation of drugs from foreign countries.

"CanaRx Services and similar companies often state incorrectly to consumers that their prescriptions are 'FDA approved' or use similar language, which could lead consumers to conclude mistakenly that the prescription drugs sold by the companies have the same assurance of safety and effectiveness as drugs actually regulated by the FDA," the agency said in a statement.

FDA gave CanaRx 15 days to respond to the warning or face legal action, possibly seizure of products, an injunction, or both.

But Albano is not backing down and intends to continue the city's program, said Nick J. Breault, Albano's press secretary.

"We are staying the course with the program," he said.

Springfield initiated the voluntary program in July after Albano journeyed last February to Canada where he met with physicians and CanaRx representatives to discuss a possible program, Breault said.

The mayor inspected CanaRx's facilities and determined that the company's operation was safe, he added.

The program offers Springfield's 6,000 employees and 3,000 retirees enrolled in the city's health plan the option of using CanaRx's mail-order service to buy prescription drugs from Canadian pharmacies, said Chris Collins, insurance program director for the city.

Collins estimated that the program would save the city between $4 million and $8 million.

The city examined costs of the top nine drugs purchased by employees, retirees, and their family members and determined that Springfield would have saved $1.4 million on drugs last year had it initiated the program a year earlier, he said.

"And that is just of the top nine," Collins said. "We have about 10,000 people enrolled in our health plan who get 30-day supplies of at least one prescription drug on a regular basis."

Albano told National Public Radio yesterday that he personally saves the city about $850 a year by purchasing insulin, blood-glucose test strips, and syringes for his son through the program.

FDA said yesterday it had evidence that CanaRx had not properly stored and shipped insulin products, "potentially compromising the safety and effectiveness" of the drug.

"Because the medications obtained and shipped by operations such as CanaRx are not subject to FDA’s safety oversight, they could be outdated, contaminated, counterfeit, or contain too much or too little of the active ingredient," FDA stated.

Some members of Congress have disagreed with FDA's position about the safety of drugs imported from Canada.

After the House passed legislation in July that would allow reimportation of drugs from certain foreign countries, Rep. Rosa L. DeLauro (D-Conn.) said that "the issue of reimportation has never been about safety."

"We can guarantee safety," she said. "It is about price. It is about lowering costs so that Americans do not have to pay up to 10 times what people in other countries pay for their prescription drugs."

In an act of support for Springfield's program, DeLauro and several members of Congress held a joint press conference with Albano today on Capitol Hill.

"The steps Mayor Albano is taking for his son and the 152,000 people of Springfield, Massachusetts, by purchasing drugs from Canada are the same steps millions of seniors take every year for themselves when they travel across the border to buy their prescription drugs at a cheaper price. They understand, as Mayor Albano does, that safety is not the issue," DeLauro said.

Canada, she said, "must meet virtually every statutory requirement they are required to meet in this country."

But, FDA warned, "foreign dispensers of drugs to American citizens may provide patients with incorrect medications, incorrect strengths, medicines that should not be used in people with certain conditions or with other medications or medications without proper directions for use."

Although many legitimate Internet pharmacies provide safe and possibly more convenient access to prescription services, the agency argued, foreign Internet pharmacies selling to U.S. residents operate outside the law.

State boards of pharmacy are responsible for determining whether pharmacies operating within the state are doing so in compliance with state law, FDA said.

"In the U.S., state law requires proper licensing for a pharmacy to sell prescription drugs," the agency said. "In this case, it appears that CanaRx is not a licensed Canadian pharmacy subject to regulatory oversight, and so may place patients at additional risk."

The National Association of Boards of Pharmacy (NABP), in a statement it issued at its 2003 Fall Legislation Conference held in Washington earlier this week, said that the illegal importation of medications is a serious health concern.

"NABP and the state boards of pharmacy recognize that consumers are seeking to purchase medications from outside of the United States motivated primarily by the need to procure less expensive medications. Access to affordable medications and maintaining the safety and integrity of our medication distribution system are two important but separate issues. Both issues must be addressed but the safety of U.S. consumers must not be compromised by allowing the illegal importation of medications."

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