A new FDA policy threatening legal action against third parties that make it possible for U.S. residents to import less-expensive prescription drugs from Canada "drew mixed reaction" yesterday in the United States and Canada, the Wall Street Journal reports (Baglole, Wall Street Journal, 3/13). FDA Associate Commissioner for Policy and Planning William Hubbard stated in a Feb. 12 letter that all parties such as health insurers or claims processors that help arrange the purchase of drugs in Canada can "be found civilly and criminally liable" under the federal Food, Drug and Cosmetic Act, which the federal government had until now largely chosen not to enforce with regard to prescription drug reimportation. The letter, written in response to questions from a lawyer representing health plans, said the policy is not primarily aimed at consumers (Kaiser Daily Health Policy Report, 3/12). While it is illegal in the United States to import prescription drugs from any foreign country, the FDA permits people in the United States to import a 90-day supply of prescription drugs from Canada for personal use (Wall Street Journal, 3/13). Responding to the FDA's new restriction on third parties, Rep. Bernard Sanders (I-Vt.) said, "It is an outrage that the FDA would be siding with the pharmaceutical industry, one that charges the American people the highest prices in the world" (Appleby, USA Today, 3/13). Sen. Debbie Stabenow (D-Mich.) said, "The FDA is going in exactly the wrong direction," adding, "The agency should be working with us to open the border to Canada in a safe way" (Pear, New York Times, 3/13).
Support for Policy
The Pharmaceutical Research and Manufacturers of
America praised the move. "These illegal imports threaten the
integrity of the U.S. drug supply and the health and safety of American
patients," PhRMA spokesperson Bruce Lott said (Wall Street
Journal, 3/13). Nancy Pekarek, a spokesperson for GlaxoSmithKline, which earlier
this year became the first drug company to cut off Canadian wholesalers
that do business with pharmacies that sell to the United States, said, "We
should not send seniors across the border as the solution to a problem of
cost and access. The solution is passage of a Medicare drug benefit"
(USA Today, 3/13). Canadian Medical
Association President Dana Hanson added, "We feel Internet pharmacies
could jeopardize patient safety, and we're against them" (Wall
Street Journal, 3/13).