FDA officials testify against prescription drug reimportation
May 22 2004 12:00 AM ET
Food and Drug Administration officials on Thursday testified at a Senate hearing that allowing U.S. consumers to reimport lower-cost prescription drugs from other nations would present numerous safety problems. FDA associate commissioners William Hubbard and John Taylor, speaking at a Senate Health, Education, Labor, and Pensions Committee Hearing, said drugs reimported from other nations could not be guaranteed to be safe or effective. They referred to a list of counterfeit medications that have been sold by firms in India, Indonesia, and Pakistan as indicative of the safety issues that can arise when reimporting drugs. They also said that the drug reimportation bill currently being debated by Congress will not provide the FDA with resources to ensure that reimported medications are safe.
The bill being considered would allow U.S. consumers to buy as much as a 90-day supply of prescription drugs from Canadian pharmacies, where the exact same drugs marketed in the United States sell for a fraction of their U.S. price. Some anti-HIV medications sell in Canada at half their U.S. price due to cost controls in the country; other medications are priced at up to 80% off the U.S. price. The bill also would allow U.S. pharmacists and prescription drug wholesalers to reimport medications from Canada and eventually also from Japan, Australia, New Zealand, Switzerland, and some European Union nations.
Several committee members told the FDA officials that it is likely a reimportation bill will pass despite their opposition to it and that their help is needed to ensure the safety of reimported drugs. "We need a new system, and we need your help to get a new system," said Sen. Hillary Rodham Clinton (D-N.Y.), reports Congress Daily. "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. Sen. Barbara Mikulski (D-Md.) added, "The reason people are going to Canada is because they are desperate." Committee chairman Sen. Judd Gregg (R-N.H.) said he supports drug reimportation and will introduce a separate bill next week to allow for limited drug reimportation from Canada. "The American people really are seeking the opportunity to go to other countries to purchase these drugs," he said. "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."