'Net pharmacies stir legality questions

Drug Store News,  March 23, 2003  

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It's so simple you wish you had thought of it yourself. All you need is a door, a desk, a person and an Internet connection. And you, too, can open your very own Best Canadian Prescription Service, a chain of enterprises that facilitates Canadian online pharmacy importation of pharmaceuticals, funneling that business through its sister company, LePharmacy.com, licensed by the Manitoba government as an Internet pharmacy.

There's just one hitch. The practice could be illegal-depending upon who you talk to.

"What makes it illegal?" asked Mark Lazar, chairman and chief executive officer of LePharmacy.com, in a telephone conversation with Drug Store News. "Unless we're reading the law differently, under the 'compassion drug act, what you'll see is that the laws state that you're allowed to import drugs that a into two categories and under several conditions." Those conditions include the requirement that a prescription exist and that the importation be for personal use and limited to a 90-day supply. "You are allowed to import certain drugs under those circumstances," Lazar said. The categories of drugs approved for import into the United States include experimental medicines approved in a country outside the United States but not in the United States. The other one is if it's already Food and Drug Administration-approved, Lazar said.

The FDA begs to differ

On March 10, the FDA testified on the Canadian pharmaceutical import business to Florida's House Committee on Energy and Commerce. John Taylor, FDA associate commissioner of regulatory affairs, said: "Under the Federal Food, Drug and Cosmetic Act, it is unlawful to import unapproved, misbranded and adulterated products into the United States. This includes foreign versions of U.S.-approved medications, as well as drugs that are made in the United States, exported to other countries, and then subsequently reimported to the United States."

Taylor continued: "FDA's personal importation policy is often misunderstood. The policy is not a license for individuals to import unapproved and, therefore, illegal drugs for personal use into the United States."

Lazar acknowledges he is facilitating the importation of unapproved medicines into the United States, but only because the FDA has not approved any Canadian labels for an American population. So "unapproved" is in name only, the contents of the medicines are FD A-approved products, Lazar said.

There were seven Best Canadian Prescription Service locations up and running as of March 12, with an additional 13 slated to open by the end of the month. Current locales are located as far north as Albany, N.Y., as far south as Jupiter, Fla., and as far west as Boulder, Cob. Lazar hopes to have at least one Best Canada storefront in each state by the end of the year.

The business model is certainly low maintenance. Best Canada operates on a franchise model, meaning it is the franchisee's responsibility to locate a small space for rent, preferably within a stone's throw of a large, low-income senior population--the chain's target demographic. Lazar likened it to an old Sears catalog store.

Outside of that, the overhead for the prescription facilitation business is low. A payment-processing system, a fax machine, a computer to facilitate the online interaction and at least one employee who doesn't even have to have any pharmacy experience, not even that of a pharmacy tech. "There are absolutely no drugs on the facility, nothing touches the facility," commented Lazar. "[The agent] is a facilitator, they give absolutely no advice whatsoever, even if asked," Lazar emphasized. "In fact, they've been instructed quite clearly that they have no right to give any of that kind of counsel."

The prescription, which is required for the transaction, is verified by both a Canadian physician and a Canadian pharmacist. "There's absolutely no difference between the quality of a dispensing Canadian pharmacist and the quality of a dispensing American pharmacist," Lazar added. "They follow, fundamentally, the same rules and regulations."

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