An international drug company has turned off the supply tap, a wave of protest has erupted, and officials still don't know how to deal with online Canadian pharmacies that sell directly to customers in the US.
Although such purchases are technically illegal, US Customs authorities and the Food and Drug Administration (FDA) are not cracking down. Carmen Catizone, executive director of the National Association of Boards of Pharmacy, knows why. “It's a political hot potato, and the FDA is caught in the middle.”
(As this issue went to press, the FDA announced that it would prosecute Internet-based companies that sell Canadian drugs and insurance companies that pay for them. It did not say how it would do this, but will likely face a lively response from seniors if it does. — Ed.)
Seniors' organizations across the US have already advocated a boycott of products made by the world's number 2 drug company, GlaxoSmithKline Inc., after it stopped shipping drugs to Canadian wholesalers that sell to online pharmacies. The seniors' groups — and some politicians — have charged that Glaxo is placing its bottom line ahead of public health. The company says it acted due to safety concerns.
The FDA also stated in a Feb. 12 letter that all drugs exported to the US from Canada in this way contravene federal legislation. “Generally, such drugs are unapproved, labelled incorrectly and/or dispensed without a valid prescription,” the letter says.
But officials who attended an international meeting in Ottawa in late February say FDA representatives admitted they lack the resources to enforce the law and that neither US Customs nor the FDA are bothering to seize prescription drugs at the border. “There are issues around enforcement,” said Jeff Poston, executive director of the Canadian Pharmacists Association. “Inspectors are allowed to exercise a certain amount of discretion.”
Catizone says the FDA needs more resources but this is unlikely because Congress “isn't very supportive.” He says there are only 2 ways to resolve the situation: “The resources have to be provided to the FDA and Customs to seize those packages, or the laws here in the US have to be changed.”
In the meantime, Canadian authorities appear to be supporting online pharmacies, which have become a growth industry. The Competition Bureau is investigating Glaxo's actions, and earlier this year Manitoba started issuing licences to online pharmacies, authorizing them to sell to international customers.
Many Canadian officials, such as Ron Guse, registrar for Manitoba's pharmacists, say they're primarily concerned with safety issues associated with supplying American customers. “What's worrisome from a pharmacist's perspective is it's really sort of a piecemeal form of service,” says Guse. “It goes back to not knowing the complete medication background of the patient.” Certain pharmacies, he adds, are having Canadian physicians cosign US prescriptions without knowing anything about the patient.
Following the Ottawa meeting, the National Association of Pharmacy Regulatory Authorities said it would review those discussions before considering what, if anything, should be done.
Guse, who says many online pharmacies provide adequate service, says he will spend the coming months investigating and shutting down those that don't. — Brian Whitwham, Ottawa