[Pharm-policy] House goes for parallel imports

[Thiru Balasubramaniam]

Rob Weissman posted this on ip-health.

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HEALTH
House OKs Amendments To Permit Drug Reimportation
   For the third time in two weeks, the House Monday night went
on record against high drug prices, voting overwhelmingly on two
separate amendments to the FY2001 Agriculture appropriations bill
to allow U.S. citizens to bring back cheaper prescription drugs
from other countries. The slightly different amendments by Reps.
Joseph Crowley, D-N.Y., and Tom Coburn, R-Okla. - which passed by
363-12 and 370-12, respectively - along with a bill by Rep. Gil
Gutknecht, R-Minn., that passed on suspension by voice vote June
28, all are aimed at blocking a 1988 law that forbids the
reimportation of U.S.-made prescription drugs from other
countries. Crowley's amendment would go the furthest, simply
blocking the FDA from enforcing the 1988 Prescription Drug
Marketing Act. Coburn's amendment would block the FDA from
interfering with the importation of drugs approved in the United
States that were made in an FDA-approved facility in the United
States, Canada or Mexico. Gutknecht's bill would restrict the FDA
in certain cases from sending consumers warning letters that re-
importation is illegal. Backers of the amendments pointed to the
fact that drugs in this country often cost four times what they
cost overseas. "We have a crisis in prescription drugs, but it is
not a crisis in Medicare, it is a crisis in price," Coburn said.
   But the prescription drug industry, already under the gun from
Vice President Gore and others, insists that the amendments could
hurt those they are intended to help. "These amendments would
jeopardize patient safety," said Judith Bello, executive vice
president of the Pharmaceutical Research and Manufacturers of
America. The 1988 law, Bello said, "was based on a two year
investigation of this issue, many days of hearings, and a
thorough set of congressional findings" that in many cases drugs
that had left the country were adulterated or lost their potency.
"For that to be overturned without hearings . is of great
concern," she said. Even the FDA has argued against relaxing the
restrictions in the 1988 law. "One has to be concerned about a
safety issue here," FDA Commissioner Jane Henney told a Senate
committee in March. Among the handful of members voting against
the amendments was Commerce ranking member John Dingell, D-Mich.,
who led the investigation that produced the 1988 law. - by Julie
Rovner