A legal opinion drafted last month by an FDA official warns that third parties that make it possible for Americans to import less-expensive prescription drugs from Canada may be violating civil and criminal law, the Wall Street Journal reports. Promoting a goal of the pharmaceutical industry, the Feb. 12 letter by FDA Associate Commissioner for Policy and Planning William Hubbard states that all parties that "cause a prohibited act" may "be found civilly and criminally liable" under the federal Food, Drug and Cosmetic Act. The letter -- written in response to questions from a New Orleans lawyer representing health plans -- adds that parties participating in arrangements in which a health insurer or claims processor helps arrange purchase in Canada "does so at its own legal risk." Hubbard noted in the letter that the agency's "highest enforcement priority would not be actions against consumers"; the Journal reports that the FDA's position could lead some third parties to deny reimbursement for drugs purchases in other countries. The letter represents the FDA's "strongest language yet" about the issue of importing drugs from Canada, according to the Journal, as the agency in the past has hesitated to appear to be "punishing" U.S. residents, particularly seniors, who seek to save money by purchasing drugs from Canada. The FDA has allowed individuals to bring small amounts of medication for personal use from Canada into the United States, but that practice now raises questions about the difference between "minor personal use" and the "regular practice of buying" from Canada to save money, the Journal reports. Officials at UnitedHealth, the largest U.S. insurer, which reimburses members for drugs purchased in Canada, said the company's policy is designed to help members who may be traveling in Canada (Burton, Wall Street Journal, 3/12).
House Subcommittee Considers Imports
The House Energy and
Commerce Committee's Subcommittee on Oversight and Investigations on March
10 met in Aventura, Fla., to address the increasing number of people
illegally importing prescription drugs from Canada, the Miami
Herald reports (Dorschner, Miami
Herald, 3/11). The FDA estimates
that between three million and 10 million people are illegally importing
prescription drugs, and according to John Taylor, associate commissioner
for regulatory affairs at the FDA, the numbers are "growing all the time,"
the Fort
Lauderdale Sun-Sentinel reports (McVicar, Fort Lauderdale
Sun-Sentinel, 3/11). Canadian Web sites offer prescription
drugs at savings of up to 50%, and federal officials "have been hesitant
to move against" them, the Herald reports. The FDA proposed
to clamp down on illegal prescription drug imports two years ago, but
Taylor said the action had not yet been authorized by HHS Secretary Tommy Thompson (Miami
Herald, 3/11). He added that the agency lacks the personnel to stop
importation or to monitor the quality of the drugs. Reps. Peter Deutsch
(D-Fla.), Jim Greenwood (R-Pa.) and Eliot Engel (D-N.Y.) convened the
hearing (Fort Lauderdale Sun-Sentinel, 3/11).