FDA Releases Report on Inspection of Prescription Drug Imports From Canada
The FDA on Tuesday released a report on the results of an inspection of prescription drugs imported from Canada and other nations, the AP/Las Vegas Sun reports. The FDA conducted the spot inspection in November in Buffalo, N.Y.; Chicago; Cincinnati; Dallas; and Memphis, Tenn. The inspection found 1,728 medications unapproved for sale in the United States, the report said. About 80% of the prescription drugs inspected were shipped from Canada, but some of those medications were manufactured in India, Pakistan and Thailand, according to the report. The report also said that the inspection found batches of foreign influenza vaccine doses, "presumably destined for municipalities with shortages," the AP/Sun reports. The report did not identify who ordered the vaccines but said that an investigation remains open. According to the report, the inspection also found a number of controlled substances and prescription drugs that posed health risks, such as:
- A version of the acne medicine Accutane, which can cause birth defects, shipped without the U.S. pregnancy test requirement;
- Foreign versions of the blood thinner warfarin, which can have different levels of potency based on production conditions;
- Many medications that contained no instructions or warnings about side effects, as well as treatments with labels not written in English, such as human growth hormone labeled only in Chinese;
- The experimental medication atrasentan, labeled as "medical study cancer samples" for research use (AP/Las Vegas Sun, 1/27);
- Five packages of Serevent, an asthma medication manufactured by GlaxoSmithKline that was recalled in Canada because of a production defect (California Healthline, 1/26); and
- Several medications that contained codeine or tranquilizers.
In related news, Sen. John McCain (R-Ariz.) later this year plans to introduce legislation to allow the reimportation of prescription drugs from Canada, The Hill reports. Although the details of the bill "have not been ironed out," the "politics of a McCain push to legalize drug reimportation could be felt throughout the 2004 presidential campaign," The Hill reports. Many Senate Democrats would likely support the legislation, and AARP Executive Director and CEO Bill Novelli said that the group might support a three-year Canadian reimportation bill. However, Republican leaders in the House and Senate, as well as the Bush administration, "have no plans to move ... a reimportation bill," The Hill reports. McCain and other lawmakers on Wednesday plan to attend a bicameral, bipartisan "strategy session" on reimportation, according to The Hill. Jeff Trewhitt, a spokesperson for the Pharmaceutical Research and Manufacturers of America, called reimportation a "risky scheme." He added that a Canadian reimportation bill would not work because Canada "has flexible product importation laws," which allow the nation to import prescription drugs manufactured in Bulgaria, India, Pakistan and South America and subsequently ship them to U.S. consumers (Cusack, The Hill, 1/28).
The free-market think tank Pacific Research Institute on Tuesday held a forum on health care that included a discussion on reimportation, Reuters reports. The forum, held in San Francisco, included comments from U.S. Nobel laureate Milton Friedman, who opposes reimportation, and Rep. Gil Gutknecht (R-Minn.), who supports reimportation (Swartz, Reuters, 1/27).
- MPR's "Marketplace" on Tuesday reported on the business of online pharmacies in the Canadian province of Manitoba. The segment includes comments from Robert Fraser, director of pharmacy for CanadaDrugs.com; John Graham, adjunct scholar and former director of health and pharmaceutical policy at the Fraser Institute; David MacKay, executive director of the Canadian International Pharmacy Association; MaryAnn Mihychuk, minister of the Manitoba Department of Industry, Economic Development and Mines; and Minnesota Gov. Tim Pawlenty (R) (Ungar, "Marketplace," MPR, 1/27). The complete segment is available online in RealPlayer. In addition, the program included an interview with Friedman (Brown, "Marketplace," MPR, 1/27). The complete segment is available online in RealPlayer.
- KPCC's "Talk of the City" on Monday included an interview with Time magazine staff writer Don Barlett, Assembly Health Committee Chair Dario Frommer (D-Glendale) and Trewhitt about two California reimportation bills (Felde, "Talk of the City," KPCC, 1/26).