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Agency tries to get a handle on cross-border trade
FDA has issued a warning letter to CanaRx Services, a Windsor, ON, online broker, for causing “the introduction of unapproved new drugs and misbranded drugs into interstate commerce” in the US, and requests that the company “immediately cease” such distribution. “Failure to do so immediately may result in further regulatory action, including seizure or injunction without further notice.” Sounds pretty stern—and the action would seem to invite CanaRx to go out of business, since its sole purpose seems to be to manage the cross-border transactions--but but it’s unclear what regulatory authority FDA can exert in Canada.
“Our legal team is preparing a formal response to FDA’s Warning Letter,” stated G. Anthony Howard, CEO, in a letter posted to the company’s website. He blames the action on “the current increase in pressure by the international pharmaceutical industry to preserve its profit margins in the United States.”
The CanaRx operation seems to be set up like many, many other “Canadian pharmacies” that have bedeviled the agency and state pharmacy boards for years, with several significant twists. CanaRx says it has been operating thus for some 15 years, and has an energetic campaign of setting up dedicated, cost-saving services to city and county governments, union funds and private employers (it has over 150 website addresses, many of which are tied to these specific entities.) While it requires a valid US-issued prescription for fulfillment, the prescriptions might be filled from pharmacies in Canada, the UK or Australia. (CanaRx calls these countries “Tier 1” suppliers, echoing some proposed Congressional legislation from the past, but the classification doesn’t have current legal force.) CanaRx merely brokers the transaction and doesn’t claim to be a pharmacy itself. It doesn’t offer generic products, but does offer the “generic version” of branded products that might be available outside the US. Finally—in an interesting twist to minimize medical and pharmacy issues—it only provides refills, instructing users “When taking a new-to-you medication a local trial is required in which initial counseling would be received from a local pharmacy. This ensures that you know how to properly take the medication and are aware of possible side effects.“
FDA cites numerous risks in the CanaRx process, including not receiving REMS information (which can apply to the pharmacist as well as to the patient); the fact that some medications are sold in different dosages than the approved US ones; and the risk of receiving counterfeit, subpotent or superpotent medications, since all of this is happening outside FDA regulatory purview.
Several states, and several federal legislators, are pushing to legalize largescale drug importation; it shows up as a new bill, S.61, introduced by Sen. Chuck Grassley (R-IA) in January, as well as S.97 by Sen. Bernie Sanders (I-VT). Rep. Elijah Cummings (D-MD) introduced HR.447, with 26 cosponsors. Between importation, drug-pricing debates and healthcare reforms, pharma lobbyists in Washington will have their hands full this year.