Congress Puts Reimportation Back on the Table
A Senate Commerce, Science and Transportation Subcommittee on Wednesday held a hearing on legislation proposed by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) that would allow consumers, pharmacies and drug wholesalers to purchase FDA-approved drugs that are manufactured at FDA-inspected facilities in other countries, CQ HealthBeat reports (Reichard, CQ HealthBeat, 3/7).
The bill would establish a regulatory framework for reimportation, including a requirement that FDA regulate shipments of prescription drugs reimported into the U.S. for commercial or personal use. Reps. Rahm Emanuel (D-Ill.) and Jo Ann Emerson (R-Mo.) have introduced similar legislation in the House (American Health Line, 1/11).
The bill would allow drug reimportation from 19 countries (AP/Wall Street Journal, 3/7). The bill also would instruct FDA to inspect Canadian drug exporters 12 times per year (Lopes, Washington Times, 3/8).
Dorgan cited a Congressional Budget Office estimate that the bill would generate $50 billion in direct savings over 10 years, including $6.1 billion in savings for the federal government. Dorgan expressed confidence that the bill -- which has 31 co-sponsors -- has enough support to win committee approval, although neither a markup nor a floor time has been scheduled, CQ HealthBeat reports (CQ HealthBeat, 3/7).
Dorgan said, "My goal is not to force Americans to go to Canada to purchase their drugs but rather to create a little competition in the market so that we can put real downward pressure on domestic drug prices."
Randall Lutter, acting deputy commissioner for policy at FDA, said the agency lacks the resources to administer a "substantial" new program. Lutter said, "We have no way of tracking the Web sites that sell these unapproved drugs, and we can't stop the drugs at the border with the resources we have" (Washington Times, 3/8).
Pharmaceutical Research and Manufacturers of America President and CEO Billy Tauzin said the legislation would increase drug counterfeiting and result in patient deaths. "We'll rue the day we opened up that flood and the deaths will pile up," Tauzin said (Talbott, CongressDaily, 3/8).
Tauzin said, "There is no indication that implementing importation would result in cost savings. The costs of counterfeit-resistant technologies and industry and government testing and inspections likely would run billions of dollars each year" (CQ HealthBeat, 3/7).
CongressDaily reports that Dorgan "conceded counterfeit drugs present a problem but pressed Lutter and Tauzin for their analyses of the regulatory system his bill would establish."
Lutter said he had not read the bill and was unprepared to provide "legislative assistance."
Tauzin said he would send his analysis of the proposal at a later date and would work with the panel on the bill (CongressDaily, 3/8).