Reimportation Bill Would Create 90-Day Deadline for FDA System
As expected, Sen. Chuck Grassley (R-Iowa) on Thursday introduced a bill (S 2307) to immediately remove federal barriers to the reimportation of lower-cost, U.S.-made prescription drugs from Canada, the AP/Las Vegas Sun reports (Sherman, AP/Las Vegas Sun, 4/8). The legislation would create a 90-day deadline for FDA to develop a system to register and inspect Canadian suppliers. After that, U.S. consumers would be able to purchase prescription drugs only from Canadian companies that have been inspected and registered by FDA. After two years, the bill would allow the reimportation of prescription drugs from other countries, including Australia, Japan and members of the European Union. To reimport prescription drugs, U.S. consumers would need prescriptions from U.S. doctors, and the consumers could only purchase treatments approved by FDA. In addition, the bill would not allow the reimportation of some types of prescription drugs, including potentially addictive painkillers. Grassley said that the cost of setting up an FDA inspection and registration system would be covered by fees paid by the Canadian exporters. He added that FDA estimates that the agency would need $100 million per year to ensure the safety of reimported drugs are "outrageous" and that the true cost of safety inspections would be much lower. Grassley also said that the bill would eliminate the tax deduction for advertising costs of any drug companies that cut off supplies to Canada. The bill would reward drug makers that conform to the reimportation program with increased federal funds for research (California Healthline, 4/8). FDA Associate Commissioner William Hubbard said the agency is reviewing the legislation but added that it "raised several concerns," particularly that it would allow the reimportation of drugs that are equivalent to treatments approved by FDA, according to the AP/Sun (AP/Las Vegas Sun, 4/8).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.