FDA Inspection of Prescription Drug Imports From Canada Raises Safety Concerns
A second FDA "blitz" inspection of prescription drugs imported from Canada found that most of the 2,000 packages examined contained foreign versions of U.S. medications that agency officials said "might not be safe," the New York Times reports (Harris/Davey, New York Times, 1/24). In September, FDA officials announced that a spot check of imported prescription drugs conducted last summer found that 88% of the medications were not approved for U.S. use. FDA officials examined 100 packages per day for three days in July and August at mail centers in Miami, New York and Carson, Calif. Customs officials selected packages from nations known for international prescription drug shipments. Canada accounted for about 16% of the packages, India accounted for 14% and Thailand accounted for about 14%. Other nations included Brazil, China, Mexico, Peru and the Philippines. FDA officials found that 1,019 of the 1,153 packages examined contained unapproved prescription drugs -- medications not produced in FDA-inspected facilities and not sold with FDA-approved labels and directions (California Healthline, 9/30/03).
The latest inspection, conducted in November, found that five of the packages examined contained Serevent, an asthma medication manufactured by GlaxoSmithKline that was recalled in Canada because of production defect. Tom McGinnis, head of pharmacy for the FDA, said that U.S. residents who ordered Serevent from Canada "probably got that defective product and weren't notified." FDA Commissioner Mark McClellan said the inspections indicate that prescription drugs imported from Canada often are manufactured "in distant corners of the world," the Times reports. McClellan said that the FDA could not determine the safety of the medications in the latest inspection because "it's so hard to tell." Neither of the two inspections included chemical tests of the prescription drugs. The FDA this week will announce the full results of the latest inspection as part of a "coordinated push by the Bush administration to stop drug imports and defuse a budding confrontation between Washington and the states," the Times reports. McClellan said that the FDA seeks to work with states and municipalities that have announced plans to consider or establish programs to purchase prescription drugs from Canada, but he added that the agency is "definitely not ruling out taking legal action against cities and states." McClellan said that the FDA and CMS plan to issue a joint report that will include proposals to help states and municipalities reduce their prescription drug costs, such as increased use of generic and over-the-counter medications.
The Times reports that many governors and mayors "flatly dismiss" FDA concerns about the safety of prescription drugs purchased from Canada because the agency has "yet to identify a single patient harmed" by the practice. They added that Health Canada, which regulates prescription drugs in Canada, has standards similar to those of the FDA. "This has little to do with health and safety and everything to do with the pharmaceutical industry," Peter Clavelle, mayor of Burlington, Vt., said, adding that he plans to implement a program by March under which city employees and their families can purchase prescription drugs from Canada. Minnesota Gov. Tim Pawlenty (R), who supports the practice, added, "This is all going to come to a head in 2004. Either the FDA will sue somebody or throw someone in jail over this, or the pharmaceutical companies choke off supply, or the FDA comes to their senses" (New York Times, 12/24).
A Web site that Wisconsin Gov. James Doyle (D) said last month would help state residents purchase prescription drugs from Canada only contains a warning that the practice is illegal, the AP/Washington Times reports. The Web site, which the state launched on Wednesday, does not include links, addresses or phone numbers to Canadian pharmacies. In a statement on the Web site, Doyle said, "I would like to provide you with the names of those Web sites, but I can't," adding, "The Bush administration refuses to permit states to help people save money by purchasing medicine from Canada." Dan Leistikow, a spokesperson for Doyle, said that the Web site is "a work in progress" and may include links to Canadian pharmacies in the future, the AP/Times reports. Tom Frazier, executive director of the Coalition of Wisconsin Aging Groups, said that the Web site "was certainly less than what I thought they were going to do." David MacKay, director of the Canadian International Pharmacy Association, said that states legally can refer residents to Canadian pharmacies, adding, "Maybe Doyle has a lower threshold for antagonizing the FDA." McGinnis did not comment on the legality of the practice (AP/Washington Times, 1/26). The Web site is available at http://www.drugsavings.wi.gov/.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.