Dorgan Suggests Limiting Drug Reimportation Law to Canada
Even though the Clinton and Bush administrations both have delayed legislation enacted last fall that would allow pharmacists and wholesalers to reimport FDA-approved drugs from foreign countries, several senators continue to pursue the issue and are weighing whether to limit the law to allow reimportation only from Canada, the AP/Baltimore Sun reports. FDA officials have said they will not implement the legislation because of concerns about counterfeit or altered medicines. During a hearing of the Senate Commerce Subcommittee on Consumer Affairs, Foreign Commerce and Tourism, Sen. James Jeffords (I-Vt.) said, "I would argue that FDA must stop telling us what will not work and must now tell us what will work." Subcommittee Chair Byron Dorgan (D-N.D.) said that to alleviate safety concerns, senators could rework the law to allow reimportation only from Canada, which has a drug approval process similar to the one in the United States (AP/Baltimore Sun, 9/6). He added, "If we limit it to just Canada, then we'll see if anybody else involved can say we have safety problems." The United States would have a "relatively higher degree of confidence in Canada," FDA Associate Commissioner William Hubbard said (Fulton, CongressDaily, 9/5). However, he said that limiting reimportation to Canada still "would not protect Americans from worldwide counterfeiters willing to sell harmful or ineffective medicines to a lucrative U.S. market." He added, "It's virtually impossible for any pharmacist or physician or anyone else to know what's in these little packets" (AP/Baltimore Sun, 9/6). A source "close to the House Commerce Committee" said that limiting the law to Canada is not a long-term solution, adding, "The minute this problem rises above the current noise level, the drug supply is going to be significantly lessened for Canadians, companies will supply less and the (Canadian) government will find a way to raise prices" (CongressDaily, 9/5).