FDA Officials Testify Against Prescription Drug Reimportation at Senate Committee Hearing

FDA officials on Thursday "tried to extinguish growing sentiment" in the Senate to allow the reimportation of lower-cost prescription drugs from other nations, CQ Today reports (Schuler, CQ Today, 5/20). At a Senate Health, Education, Labor and Pensions Committee hearing, FDA Associate Commissioners William Hubbard and John Taylor provided a "long list of warnings on the difficulty of ensuring the safety and effectiveness" of reimported prescription drugs, CongressDaily reports. The list warned of counterfeit medications from India, Indonesia and Pakistan, as well as prescription drugs that have the same chemical analysis as others but do not properly dissolve in the bloodstream. Hubbard and Taylor said that the safe reimportation of prescription drugs would require "extreme resources" that totaled in the hundreds of millions of dollars. They added that the reimportation bills currently under consideration -- such as a bill (S 2328) sponsored by Sens. Edward Kennedy (D-Mass.) and Byron Dorgan (D-N.D.) -- would not provide FDA with adequate resources to ensure the safety of reimported medications (Rovner, CongressDaily, 5/20). The Kennedy-Dorgan bill would allow U.S. residents to reimport as much as a 90-day supply of prescription drugs from FDA-approved Canadian pharmacies for personal use. After 90 days, the legislation would allow licensed pharmacists and prescription drug wholesalers to reimport medications from Canada. After one year, pharmacists and wholesalers could reimport medication from Australia, Japan, New Zealand, Switzerland or European Union nations that were members as of Jan. 1, 2003. Pharmacists and wholesalers that reimport prescription drugs would have to register with FDA and pay fees of as much as 1% of the price of the medications to fund the cost of additional federal inspectors and customs agents (American Health Line, 4/22). "It appears that the user-fee structure would not pay for the very expensive cost ... of inspection and product review," Hubbard said (CQ Today, 5/20). Taylor said that the committee should ensure that "any change does not require American consumers to give up the gold standard they have come to rely on."

Some committee members said that "it is too late to stop" reimportation and that FDA must consider proposals to ensure the safety of the practice, CongressDaily reports (CongressDaily, 5/20). "We need a new system, and we need your help to get a new system," Sen. Hillary Rodham Clinton (D-N.Y.) said (CQ Today, 5/20). She added, "It is not fair any longer for the American taxpayer, consumer and patient to be at the bottom of an inverted triangle supporting the research and development" of prescription drugs for the world. Sen. Barbara Mikulski (D-Md.) said, "The reason people are going to Canada is because they are desperate." On Wednesday, Kennedy said he has received a letter from former FDA Commissioner David Kessler that said the Kennedy-Dorgan bill "provides a sound framework for assuring that imported drugs are safe and effective" and "adjustments to this sound framework can be made to accommodate legitimate concerns of FDA or other experts." At the hearing, committee Chair Judd Gregg (R-N.H.) said that next week he will introduce a bill to allow limited reimportation, CongressDaily reports. "The American people really are seeking the opportunity to go to other countries to purchase these drugs. But we want to make sure that they have a certain level of confidence that what they are purchasing isn't going to hurt them," Gregg said (CongressDaily, 5/20). According to CQ Today, the Gregg bill represents the "likely vehicle for any legislation supported by the White House and congressional Republican leaders" (CQ Today, 5/20). NPR's "Morning Edition" on Friday reported on the Senate hearing on reimportation. The segment includes comments from Hubbard, Taylor, Clinton, Kennedy and Sen. Trent Lott (R-Miss.) (Rovner, "Morning Edition," NPR, 5/21). The complete segment is available online in RealPlayer.