FDA Warns Three Texas Companies To End Reimportation Practices

The FDA on Thursday sent letters to three Texas-based companies to inform them that they must end the reimportation of lower-cost, U.S.-manufactured prescription drugs from Canada within 15 days or could face prosecution, the Washington Post reports. The three companies -- Expedite-Rx, SPC Global Technologies and Employer Health Options -- contract with the city of Montgomery, Ala., to supply medications, which include reimported prescription drugs from Canada, to city employees and retirees (Kaufman, Washington Post, 1/23). The letters are the first step toward a court injunction against the companies (Appleby, USA Today, 1/23). FDA officials maintain that reimported prescription drugs from online pharmacies and companies such as Expedite-Rx could originate from unknown sources and nations and, in many cases, are manufactured without agency oversight. In a statement, FDA Commissioner Mark McClellan said, "We cannot tolerate shady operations that enrich a few while exposing many patients to the risks of dubious imports," adding, that U.S. laws "make crystal clear that medications on the U.S. market have to be proven to be safe and effective, and the vast majority of illegal imports fail to meet this standard" (Washington Post, 1/23). Tom McGinnis, FDA pharmacy affairs director, said that the agency is "going to move aggressively against anybody breaking federal law and putting public health at risk." However, Tom Curb, a spokesperson for Expedite-Rx, said, "We're not handling any drugs and we're not actually intermediating." He added that Expedite-Rx only processes copayment information for the Canadian pharmacy used by Montgomery and provides computer records to ensure that reimported medications do not "interact dangerously" with those purchased in the United States, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 1/22). Curb said that the FDA letter makes "various inaccurate allegations," which are "based on misconceptions." He added that "these will be corrected and/or sufficiently explained to result in a favorable outcome" (Washington Post, 1/23). Jeff Downes, a spokesperson for Montgomery, said, "We plan to continue our program during this period" (USA Today, 1/23). Downes added, "We are eagerly watching the circumstance to see how it resolves, and it may end up being resolved in the courts" (AP/Las Vegas Sun, 1/22).

In related news, officials for the Pharmaceutical Research and Manufacturers of America on Thursday said that the group will make efforts to lobby against legislation to legalize reimportation a "top priority" for 2004, the Newark Star-Ledger reports. Rick Smith, a senior vice president for PhRMA, said, "It is very clear that importation is not a safe practice" and "has been proposed as a false solution" to reduce prescription drug costs. According to Smith, many prescription drugs purchased from Canada are manufactured in other nations, such as Bulgaria, Cuba, the Philippines, Romania and Thailand. Sean Darragh, an official with PhRMA, said that prescription drug shipments from developing nations to Canada have increased by 200% to 300% this year. Alan Goldhammer, head of regulatory affairs at PhRMA, said that "it is easy for counterfeit and potentially dangerous drugs to be marketed in this way," the Star-Ledger reports. Smith said that PhRMA supports a number of alternatives to reimportation -- such as increased use of generic medications, Medicare prescription drug discount cards that will become available in the spring and assistance programs sponsored by pharmaceutical companies that help low-income residents -- to help reduce prescription drug costs. In addition, Smith said that PhRMA will work with Congress to expand health coverage to the more than 40 million uninsured U.S. residents (Cohen, Newark Star-Ledger, 1/23).