FDA Toughens Stance on
Canadian Drug Imports
Excerpt By Karen Pallarito, Reuters Health

NEW YORK (Reuters Health) - The U.S. Food and Drug Administration (FDA) appears to be stiffening enforcement of a federal policy banning imports of cheaper drugs from Canada.

The FDA crackdown could upend a rapidly expanding U.S. market for Canadian prescription imports, some observers said on Wednesday.

The federal agency signaled its tougher stance in a letter stating that any party involved in shipping prescription drugs to consumers in the U.S. may be held civilly and criminally liable.

"Those who can be found civilly and criminally liable include all who cause a prohibited act," William K. Hubbard, the FDA's associate commissioner for policy and planning, cautions in the February 12 letter.

Businesses and individuals "who aid and abet" illegal imports also can be found criminally liable, he advises.

"This is serious. The last thing we want to do is be in violation of FDA policy, so we're going to study this very carefully," said Bill Lee, president of Rx Canada Connect, a Dallas-based outfit that serves as a middleman between U.S. customers and Canadian pharmacies.

The FDA's policy change will affect older Americans most in need of lower prescription drug prices, Lee said. That population includes an estimated 6,000 to 10,000 members of the National Association of Retired and Veteran Railway Employees who have little or no prescription drug coverage. The association is a client of Rx Canada Connect.

"If the FDA gets its way here...these folks are going to be without a source of affordable drugs," Lee said.

Hubbard's letter responds to a request from New Orleans attorney Robert Lombardi, whose firm represents employer-sponsored health plans. Lombardi did not immediately respond to a request for comment.

It is illegal in the U.S. to import drugs from other countries, although the FDA has not rigidly enforced the ban.

Its lax position has spurred a burgeoning market in cross-border pharmaceutical sales. Throngs of Canadian pharmacies have set up Internet sites and opened U.S. service centers to take orders from American customers. Companies that match U.S. drug buyers with pharmacies in Canada also have sprung up.

One such outfit, SPC Global Technologies of Temple, Texas, is specifically mentioned in the FDA letter, as is SPC affiliate Expedite-Rx, which places orders with a pharmacy in Calgary, Canada.

While Hubbard declined to say specifically whether those companies are potentially liable, he said any company that participates in importing drugs from Canada "does so at its own legal risk."

He added that the FDA's "highest enforcement priority would not be against consumers."

Still, that could affect some health insurers, such as Minnetonka, Minnesota-based UnitedHealth Group, which reimburses for drugs bought in Canada.

A United spokesman quoted by the Wall Street Journal on Wednesday reportedly said the company does not believe its position encourages reimportation. He told Reuters Health the company had no additional comment.

Mark Lazar, chairman and CEO of LePharmacy.com, a Canada-based Internet pharmacy, and founder of Best Canadian Prescription Service, isn't deterred by Hubbard's letter, saying it merely articulates existing law.

"There's always been an awareness that this industry could be closed tomorrow," he conceded. "The real question is, if they were to close it, what are they replacing it with?"

Reference Source 89

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