THURSDAY, Sept. 11, 2003 (HealthDayNews) -- Moving to curb the cross-border flow of prescription drugs, the U.S. government asked a judge Thursday to shut down an Oklahoma-based company that sells Canadian drugs at about 80 storefront locations across the United States.
The U.S. Justice Department 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 lawsuit came in response to a request from the U.S. Food and Drug Administration, which said the company is importing drugs that pose a "serious threat to the public health."
"The defendant caused the importation of prescription drugs from Canadian pharmacies, which clearly violates the law and poses significant risk to the public health," the lawsuit said.
As an example, the government cited purchases investigators made that the FDA claims don't meet the United States' standards.
Agents made undercover purchases of two drugs from Rx Depot's Oklahoma operation. The investigators received "drugs that were purported to be safe and effective, but were unapproved or illegally imported into the U.S. and potentially unsafe," the FDA said.
The agency said one of the orders was for a 30-day prescription -- 60 pills of the powerful anti-depressant Serzone. Instead, the 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.
The government's civil lawsuit marks the most dramatic step yet to stop the importation of prescription drugs, which often cost American consumers as much as 50 percent less than U.S.-based pharmacies charge. The lower prices have lured a growing number of Americans, many of them senior citizens, to buy their medications from foreign sources.
That's risky, the FDA warns, because of the absence of U.S. safety regulations and quality control.
"The FDA is compelled to act against this significant public health risk," the agency's commissioner, Dr. Mark B. McClellan, said in a statement this week. "We cannot and will not stand by and let aggressive companies profit through illegal actions that put the health of Americans at risk."
But a lawyer representing Rx Depot dismissed as groundless the FDA's claims that the company sells dangerous drugs, and said it has no intention of closing down.
"The FDA has absolutely no basis whatsoever to stop importation of Canadian drugs based on safety," the Tulsa lawyer, Fred E. Stoops, said Thursday. "That is absolutely a bogus falsehood. There is no problem with Canadians getting sick and dying because they have a broken-down [regulatory] system."
In fact, Stoops added, Canada's oversight of its pharmaceutical industry is at least as stringent as the FDA's in the United States. He said each Rx Depot customer must have a valid prescription and complete a detailed health questionnaire, both of which are scrutinized by a Canadian doctor before a prescription is filled.
Customers purchasing drugs through Rx Depot can do so either at the storefront shops or on the Internet.
Stoops said he's confident the company would prevail and not face a shutdown. He said closing Rx Depot would contradict provisions of the North American Free Trade Agreement, barring proof of a "legitimate threat to public health."
He also said a government-mandated shutdown may violate antitrust laws, and he contended an overwhelming majority of the American public would favor allowing the lower-cost drugs to be imported.
"You know, on our side is the silent majority, if you will, of the citizens of America that need to be able to have access to affordable prescription drugs," Stoops said.
William Hubbard, FDA associate commissioner, said he sympathizes with those who can't afford costly prescriptions.
"My own 90-year-old mother cannot afford her drugs," Hubbard said. "I know that. But nobody made FDA the drug-price-and-safety administration. They just made us the drug-safety guys. Our mission is not to establish prices of drugs, only to make sure they are safe."
Of companies importing drugs and selling them to Amercians, he said, "We don't see safe drugs coming from these businesses."
Some independent experts questioned the validity of the FDA's assertion that prescription drugs imported from Canada pose a significant health risk.
"It seems to be that there is very little risk that U.S. consumers will obtain faulty drugs" from Canada, said F. M. Scherer, a pharmaceutical industry expert who is a professor emeritus at Harvard University's John F. Kennedy School of Government.
The FDA, Scherer said, has failed to provide evidence "necessary to judge whether there is indeed a 'potentially hazardous' situation. The FDA may be crying wolf."
Alan Lyles, an adjunct faculty member at the Johns Hopkins School of Public Health, said the safety of drug importation depends on factors including distribution channels, security and the role of medical professionals.
"I have not heard of any public health crisis in Canada resulting from Canadian citizens obtaining prescription drugs from their pharmacies," added Lyles.
But he added, "It doesn't mean that once you start having a permeable border [for drug importation] that these safeguards are maintained."
In fact, Scherer said that excluding Canada, Europe and Japan, drugs coming from other parts of the world pose "quite different risks."
The Justice Department's legal action comes nearly six months after the FDA told Rx Depot that it was violating federal law by importing the prescription drugs. In a March 21 letter, the FDA said even if a drug is manufactured in the United States and approved by the agency, only a U.S. manufacturer can legally import it back to this country. The letter also threatened legal action that could include "seizure and/or injunction."
"FDA believes that operations such as yours expose the public to significant potential health risks," the letter said.
Rx Depot, according to an FDA statement, falsely promoted drugs it called "FDA-approved" and "exactly the same as if purchased in the United States." But the FDA said in its March letter that prescription drugs purchased from foreign countries "generally are not FDA-approved, do not meet FDA standards and are not the same as drugs purchased in the United States."
McClellan said the FDA lacks the resources to assure the safety of unapproved drugs imported into the United States.
"Unapproved drugs," he said, "are more likely to be contaminated, counterfeit, contain different amounts of active ingredients or contain different ingredients altogether."
In an unrelated action, the FDA said it had warned some firms to stop sales of an "unapproved, mislabeled" version of the acne drug Accutane. The unnamed companies sold the drug over the Internet without requiring a prescription, the FDA said, and Accutane can cause birth defects and has been linked to possible suicidal thoughts in some patients.
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.
