[Pharm-policy] CQ on Dingell opposition to reimport legislation

[James Love]

Posted for SF.  Jamie


CQ
July 21, 2000

HEALTH: Dingell Is Wary Of Drug Reimportation Amendments
By April Fulton

House Commerce ranking member John Dingell, D-Mich., is concerned about
measures passed recently by the House and Senate to relax restrictions
on importing FDA-approved prescription drugs. And he has reason. 

   [SNIP]

Dingell recently signed onto a letter asking Commerce Chairman Bliley to
take up the issue in committee. The House amendments were sponsored by
Reps. Joseph Crowley, D-N.Y., and Tom Coburn, R-Okla. They passed
overwhelmingly on the House FY2001 Agriculture spending bill July 10,
taking many by surprise. 
 
The measures seek to ease consumers' access to FDA-approved prescription
medicines that are sold in other countries for a lower cost. They would
prevent the FDA from enforcing the PDMA--the law that prevents these
products from being imported by anyone other than the companies that
made them. 
 
The Commerce Committee has held hearings on related drug import issues,
such as Internet purchasing and the safety of raw drug making materials,
and has blasted the FDA for falling behind on enforcement of current
laws. Yet most of the committee voted with its colleagues for the
Crowley and Coburn amendments, which passed 363-12 and 370-12,
respectively. 

"Just because you have some nefarious products coming in doesn't mean
you prevent people from getting access to appropriate, low cost drugs,"
said a committee spokesman. The spokesman said the panel may hold more
hearings on the matter, but notes that time is running short.  "We have
a crisis in prescription drugs. But it is not a crisis in Medicare, it
is a crisis in price," Coburn said during the House debate, noting that
U.S. drug prices can be four times as high as in other countries. 
 
But Dingell, in remarks on the House floor explaining his vote against
the amendments, said that in the 1980s, while he was chairman, an
investigation he led as head of the panel's oversight subcommittee found
that reimported pharmaceuticals pose a safety risk because they could
allow counterfeit drugs to enter the market and because proper storage
and handling cannot be guaranteed. 

And in a recent letter to the FDA, Dingell said he finds little now to
indicate the problem has been solved. "In fact, the evidence suggests
the problem is getting worse. I am concerned that in our haste to find a
way to bring cheaper drugs to seniors and other needy Americans ... we
risk making changes to key health and safety laws we may later regret." 

  [SNIP]

=======================================================
James Love, Director           | http://www.cptech.org
Consumer Project on Technology | mailto:love@cptech.org 
P.O. Box 19367                 | voice: 1.202.387.8030
Washington, DC 20036           | fax:   1.202.234.5176
=======================================================