Thursday, March 08, 2007 Capitol
Hill Watch
Senate Committee Debates Legislation That Would
Establish Safeguards for Prescription Drug Reimportation
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, which also has been proposed in the
House by Reps. Rahm Emanuel (D-Ill.) and Jo Ann Emerson (R-Mo.), 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 (Kaiser Daily Health Policy Report, 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."
FDA, Rx Industry Opposed
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).