Canadian Drugs Risky, FDA Says

WASHINGTON — Setting up a legal, safe program to import drugs from Canada would cost hundreds of millions of dollars, the Food and Drug Administration’s head pharmacist said Tuesday.

Tom McGinnis insisted that the FDA would never rely on Canada’s assurances that drugs sold in Canada are safe.

McGinnis, the agency’s pharmacy affairs director, said the FDA would not piggyback its inspections on the Canadian system because the United States inspects drug manufacturers around the world, while Health Canada relies on inspections done by the drug maker’s host country.

The FDA also spurned proposals from a group of Canadian mail-order pharmacies to allow U.S. regulators to inspect their operations.

Despite the FDA’s across-the-board rejections, growing numbers of cities and states are exploring Canadian importation as a way to save money, and Congress is increasing pressure on the agency to find a way to make the process legal and safe.

Canadian officials have defended the safety of their drugs and their inspections.