Feds Pledge Continued Crackdown on Imported Prescriptions

FDA investigating Web sites, storefront operations selling meds from abroad

FRIDAY, Sept. 12, 2003 (HealthDayNews) -- A day after suing to try to close about 80 U.S. shops selling prescription drugs imported from Canada, U.S. authorities pledged to widen their crackdown on the illegal cross-border trade.

The U.S. Food and Drug Administration said Friday that it has launched investigations into 95 Web sites for allegedly selling imported prescription drugs illegally, and that many of them could face legal action that could include forced shutdown.

The FDA said it also has e-mailed nearly 200 "cyber warning letters" to domestic and foreign online sellers, informing them the sites are violating U.S. law. The agency says its enforcement efforts are increasingly focusing on storefront U.S. businesses -- most of which have opened this year -- that import prescription drugs and sell them to Americans.

"There will be further crackdown," warned William K. Hubbard, FDA associate commissioner for policy and planning. "There are very serious issues here. We have seen a lot of bad drugs. We see drugs whose expiration dates have passed, drugs that are unapproved -- even counterfeit drugs."

On Thursday, the U.S. Justice Department, acting on an FDA request, filed suit in U.S. District Court in Tulsa, Okla., seeking an injunction to close Rx Depot Inc. of Tulsa and its sister company, Rx of Canada LLC. The FDA said the storefront shops operated by the companies import and sell drugs that pose a "serious threat to the public health."

Customers purchasing drugs through Rx Depot can do so either at the storefront shops or on the Internet.

The federal action comes as more and more Americans, many of them senior citizens, buy foreign drugs through the Internet or American-based shops that place orders for them. Lower prices -- prescriptions costing half or even less than what U.S.-based pharmacies charge -- lure the customers.

Foreign companies delivered about 2 million prescription orders -- often containing more than one drug -- to U.S. customers in 2002, twice as many as in the previous year, the FDA estimates.

Some experts have questioned whether Canadian drugs in particular pose a significant health risk.

But others say the federal actions are justified.

"I don't think the FDA has much choice. These companies are blatantly violating the law and hoping that public concerns over high drug costs will let them get away with it," said David Knapp, dean of the University of Maryland School of Pharmacy. "The chain of regulatory control has been broken," Knapp said.

A lawyer representing Rx Depot, however, called the drugs the company's stores sell at least as safe as those sold by American-based pharmacies.

The lawyer, Fred E. Stoops, disputed the FDA's allegation that a federal undercover drug purchase from Rx Depot demonstrates the dangers of buying imported drugs.

FDA investigators, the suit filed Thursday said, ordered from Rx Depot a 30-day prescription -- 60 pills -- of the powerful anti-depressant Serzone. Instead, an FDA investigator who ordered the drug received 99 pills of APO-Nefazodone, a Canadian-manufactured version of the active ingredient in Serzone that has not received FDA approval.

The packaging did not indicate that more than the prescribed number of pills had been sent, but the instructions did specify that the patient take one pill twice daily, the FDA said. As a result, the agency said, a patient could have been exposed to increased risk of liver failure by taking the drug longer than the prescribed period.

But Stoops said a Canadian doctor reviewed the original prescription and "rewrote" it so it could be filled with a generic drug. And more pills were included in the order because the Canadian pharmacy it came from does not open the original packaging.

"Just because it's not approved [by the FDA] doesn't mean it's not safe," Stoops said. "That's ridiculous."

The prescription, he said, was not "mis-filled," but "filled exactly as it was ordered" by the Canadian doctor.

The National Association of Boards of Pharmacy takes a decidedly different view. Foreign prescribers "rewriting" American prescriptions often lack information regarding the patient's medical history, and unauthorized "therapeutic substitutions" have been reported, the organization said in a recent position paper on importation of foreign prescription drugs.

"Illegal importation of prescription drugs between Canada and the United States undermines the regulatory systems established in each country to protect consumers," the NABP concluded.

The independent pharmacy group said it will work closely with the FDA to prevent illegal importing of drugs, and several states have joined in enforcement efforts as well.

Even so, demand for the cheaper imported drugs continues to grow as more and more Americans seek an antidote to high prescription costs.

In one case, buying Canadian prescriptions is expected to save a Massachusetts city government and many of its employees millions of dollars a year. Many of the more than 10,000 employees and retirees in the Springfield, Mass., government's health plan buy medications from CanaRx Services Inc., said Christopher Collins, the town's insurance program director.

In July, the employees began buying from CanaRx, whose Web site lists a Detroit address. Doing so is expected to save the city about $4 million a year, and the health plan members about $1 million in co-payments, Collins said.

He said the Canadian prescriptions cost 30 percent to 80 percent less than what U.S. pharmacies charge, and adds that nobody seems worried about the safety of the imported prescriptions.

"We're not dealing with a Third World country, we're dealing with Canada," Collins said. "Canada has more stringent or as stringent laws as we do."

More information

For more on buying prescription drugs online, check out the U.S. Food and Drug Administration or the National Association of Boards of Pharmacy.

SOURCES: William K. Hubbard, associate commissioner, U.S. Food and Drug Administration, Rockville, Md.; Fred E. Stoops, attorney, representing Rx Depot, Inc., Tulsa, Okla.; David A. Knapp, Ph.D., dean, University of Maryland School of Pharmacy, Baltimore; Christopher Collins, insurance program director, Springfield, Mass.; Sept. 11, 2003, Complaint for Injunction, U.S. vs. Rx Depot and Rx of Canada LLC, U.S. District Court, Northern District of Oklahoma, Tulsa; June 24, 2003, FDA testimony before Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives
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