A bipartisan group of senators on Wednesday plans to introduce a bill that would allow the reimportation of prescription drugs from other nations, the Spokane Spokesman-Review reports (Spokane Spokesman-Review, 4/21). The group, led by Sens. Edward Kennedy (D-Mass.) and Byron Dorgan (D-N.D.), includes Senate Majority Leader Tom Daschle (D-S.D.) and Sens. Debbie Stabenow (D-Mich.), John McCain (R-Ariz.) and Olympia Snowe (R-Maine). The group has released no details about the bill (Schuler, CQ Today, 4/20). According to CongressDaily, the legislation "apparently would allow" reimportation from Canada immediately and from the European Union and other nations with "advanced drug regulatory regimes" within one year (Rovner, CongressDaily, 4/21). An unnamed Senate staff member said that the bill would require foreign prescription drug distributors to pay fees to cover the cost of increased safety inspections by FDA. In addition, the legislation would allow commercial, as well as individual, reimportation, according to that staff member (Rowland, Boston Globe, 4/21). Dorgan said that he expects the bill to reach the Senate floor for a vote this year. Barry Piatt, a spokesperson for Dorgan, called the legislation a "major step forward and a major breakthrough" that will "pave the way for a vote." He said that earlier this year Senate Majority Leader Bill Frist (R-Tenn.) promised Dorgan a vote on a reimportation bill in exchange for his decision to lift a hold on the nomination of Mark McClellan as CMS administrator. However, according to CQ Today, a reimportation bill drafted by Senate Health, Education, Labor and Pensions Committee Chair Judd Gregg (R-N.H.) is the "most likely vehicle for any movement" on the issue in the Senate. Gregg said that the legislation would "allow reimportation from Canada and other countries FDA says have an adequate regime to protect pharmaceuticals, and a process where you could purchase drugs over the Internet after the FDA has had adequate chance to review it" (CQ Today, 4/20).
Reimportation Conference
In related news, economists,
academics and pharmaceutical industry representatives said at a conference
on Tuesday that legalization of reimportation from Canada would not
"substantially" reduce prescription drug prices in the United States,
CongressDaily reports. Reimportation supporters have not
asked the "hard question -- is this going to save money in the long run?
The answer is no," Robert Freedman, executive director of public policy
for AstraZeneca,
said. Robert Helms of the American Enterprise Institute said that reimportation
would not work because pharmaceutical companies "are not going to ship the
volume to Canada to reship it back here." Freedman added that
reimportation from Europe would not work because only a few European
nations currently sell prescription drugs internationally. John Vernon of
the University of Connecticut Graduate School of Business said that the legalization
of reimportation in the United States could prompt pharmaceutical
companies to reduce their research and development budgets by 25% to 33%.
Kristina Lybecker of Drexel
University, said that she is "not surprised that Congress is not
listening to calls about potential ill effects" of reimportation,
CongressDaily reports. "On the other side you have Grandma.
And Grandma's not getting her drugs, and Grandma's getting on the bus and
going to Canada," Lybecker said, adding, "The people who will be hurt
don't yet have faces." The University of Michigan College of
Pharmacy and AstraZeneca sponsored the conference
(CongressDaily, 4/21).
Health Canada Officials Deny Rx Drug Shortage
In response to
recent claims, officials for Health Canada, the Canadian equivalent of FDA, last week
said that Canada has not experienced a prescription drug shortage because
of increased reimportation, CongressDaily reports (Rich,
CongressDaily, 4/21). At a hearing of the U.S. Task Force on
Drug Importation last week, two Canadian patient advocacy groups --
the Consumer
Advocare Network and the Canadian Treatment Action Council -- testified that
reimportation has caused prescription drug shortages in Canada (Kaiser Daily Health Policy Report, 4/15).
"To date, we haven't seen any evidence of a shortage of prescription drugs
(for Canadians) due to the practice of Internet pharmacies shipping drugs
to the United States or through cross-border sales," Emmanuel Chabot, a
spokesperson for Health Canada, said. David MacKay, director of the Canadian International Pharmacy
Association, said although some pharmaceutical companies have limited
supplies to Canadian online pharmacies that sell medications to U.S.
consumers, sales to Canadian residents for use in Canada "have not been
affected." MacKay added, "Those who say so are fear-mongering" (Rich,
CongressDaily, 4/21).