[Pharm-policy] Thompson Kills Rx Imports/Reimports

[James Love]

-------- Original Message --------
Subject: [RxPolicy] Thompson Kills Rx Imports/Reimports
Date: Tue, 10 Jul 2001 15:03:41 -0700 (PDT)
From: Rx Update <RxUpdate@excite.com>
To: RxPolicy@yahoogroups.com

or at least the ability of anyone else to import them except pharmaceutical
companies.

-----------------------------HHS PRESS RELEASE--SECRETARY THOMPSON
DETERMINES THAT SAFETY PROB LEMS MAKE DRUG REIMPORTATION UNFEASABLE


UNDEFINED

Date:  July 10, 2001
For Release:  Immediately
Contact:  HHS Press Office
(202) 690-6343


Headline:  SECRETARY THOMPSON DETERMINES THAT SAFETY PROBLEMS
MAKE DRUG REIMPORTATION UNFEASIBLE

HHS Secretary Tommy G. Thompson today told members of Congress that the
safety of prescription drugs could not be adequately guaranteed if drug
reimportation were allowed under the Medicine Equity and Drug Safety Act
(MEDS Act).

In a letter to Sen. James Jeffords of Vermont, Secretary Thompson said the
law enacted last year cannot be implemented, especially because of safety
concerns.  His findings reaffirm the decision made last December by former
HHS Secretary Donna E. Shalala.

"I believe very strongly that seniors should have access to affordable
prescription drugs," Secretary Thompson said in today's letter.  "However, I
do not believe we should sacrifice public safety for uncertain and
speculative cost savings."

Reimportation of prescription drugs by pharmacies and drug wholesalers would
remove products from the thorough safety and effectiveness monitoring
overseen by HHS' Food and Drug Administration, Secretary Thompson found.
"Opening our borders as required under this program would increase the
likelihood that the shelves of pharmacies in towns and communities across
the nation would include counterfeit drugs, cheap foreign copies of
FDA-approved drugs, expired drugs, contaminated drugs, and drugs stored
under inappropriate and unsafe conditions," he said in the letter.

The MEDS Act would allow prescription drugs manufactured in the United
States and exported to certain foreign countries to be reimported from those
countries for sale to American consumers.  The law was based on the hope
that lower pricing of drugs by those countries would be passed on to
American consumers for drugs that were manufactured in the U.S. and,
therefore, had met strict safety and effectiveness standards maintained
under FDA regulation.  A provision of the law required the HHS Secretary to
determine that adequate safety could be maintained and that costs would
indeed be expected to be reduced significantly.  Secretary Thompson's
finding today, like Secretary Shalala's, concluded that neither condition
could be adequately assured.

"Our drug approval and monitoring system, overseen by the FDA, is what
ensures that the American consumer has the safest and most effective
pharmaceutical products in the world.  It would be short-sighted to
compromise that system," Secretary Thompson said.

Today's finding's included:

· Moving from the current "closed" distribution system with relatively few
importers to an "open-border" distribution system would significantly
increase the risk that counterfeit, misbranded, and adulterated drugs would
show up on U.S. drug store shelves and in American homes.
· It would not be possible to maintain the same level of drug supply
protections in place today even with the MEDS Act requirements for
chain-of-sales documentation, drug product sampling, and product testing.
· A likely outcome would be a lowering of consumer confidence in the safety
of the drug supply.
· Costs of documenting previous sales, sampling and testing, and product
relabeling are likely to offset much, if not all, of the potential savings.
These costs are difficult to estimate and adequate information does not
exist for the Secretary to predict that net savings will result to the
American consumer.

###

Note: All HHS press releases, fact sheets and other press materials are
available at www.hhs.gov/news