BY J. MICHAEL BRODIE
The AAFP Board of Directors has given its stamp of approval for the Academy to "support legislative proposals that allow importation of drugs." The Board's action was based on two conditions. First, the drugs distributed in the United States -- including drugs imported from Canada and countries in the European Union -- should come from FDA-approved plants and be manufactured in FDA-inspected facilities. Second, an FDA approval and inspection system should supersede the current HHS safety certification process.
| "Whether drug
reimportation is debated now or in the next session, we believe these issues
must be fully explored." --James Martin, M.D. |
"The Academy Board wrestled with the development of a policy that would address both the costs to our patients and the safety and efficacy of life-saving pharmaceuticals," said AAFP Board Chair James Martin, M.D., of San Antonio. "Whether drug reimportation is debated now or in the next session, we believe these issues must be fully explored."
The AAFP Board's decision, made in August, comes in the midst of hot debate about drug importation across the nation. Senate leaders at press time were deciding whether one or both of two bills had sufficient support to force a vote. The bills are S. 2493, the Safe IMPORT Act, or the Safe Importing of Medical Products and Rx Therapies Act, written by Senate Committee on Health, Education, Labor and Pensions Chair Sen. Judd Gregg, R-N.H., and the Pharmaceutical Market Access and Drug Safety Act of 2004, S. 2328, sponsored by Sen. Byron Dorgan, D-N.D., and Sen. Olympia Snowe, R-Maine. The Dorgan-Snowe bill would open the way for the U.S. to import FDA-approved prescription drugs from 20 countries, including Canada.
The House of Representatives last year passed a drug importation bill (H.R. 2427, the Pharmaceutical Market Access Act of 2003), by a vote of 243-186.
Pharmaceutical industry leaders have taken a stand against importation because, they say, it allows for the potential introduction of unsafe drugs or phony and ineffective substitutes.
Senate Majority Leader Bill Frist, M.D., R-Tenn., himself a staunch opponent of drug imports, has expressed doubts the measures would get voted on before the November elections.
Meanwhile, the governors of three states asked Frist on Sept. 10 to let the Dorgan-Snowe bill reach the Senate floor for a vote before legislators returned to their districts in early October.
Democratic Gov. Rod Blagojevich of Illinois, in a Sept. 10 statement, said that nearly three million of his state's residents currently have no prescription drug coverage, which forces them to go without needed medicine, take smaller doses than their physicians prescribe, or go without food or other essentials in order to pay for their medicines.
"No one should be forced to make those choices," said Blagojevich. His statement mentioned the letter from himself, Republican Gov. Craig Benson of New Hampshire and Democratic Gov. Jim Doyle of Wisconsin and said, "We're doing what we can at the state level to help our citizens get their medication at a price they can afford -- even if that means buying them in places like Canada and Europe where they cost half as much."
FP Report is published by the
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Copyright © 2004 by
American Academy of Family Physicians.