[Pharm-policy] RE: [Ip-health] Thompson DOES NOT Kill Rx Imports/Reimports

Thu Jul 12 10:18:01 2001

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This headline is highly innacurate.  Thompson killed imports/reimports =
of
WHOLESALE quantities of prescription drugs.  The FDA allows personal =
use
quantities of prescription drugs to be carried across the border, and =
if the
Gutknecht Amendment passes on the House floor tomorrow (and is =
ultimately
signed into law), mail orders of personal use quantities will continue =
be
allowed as well.  Moreover, if the Sanders Amendment passes, the House =
will
have made a strong statement that wholesale importation should be =
allowed as
well.

-----Original Message-----
From: James Love [mailto:love@cptech.org]
Sent: Tuesday, July 10, 2001 6:19 PM
To: IP-Health list; pharm-policy
Subject: [Ip-health] Thompson Kills Rx Imports/Reimports

-------- 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:

=B7 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.
=B7 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.
=B7 A likely outcome would be a lowering of consumer confidence in the =
safety
of the drug supply.
=B7 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
_______________________________________________
Ip-health mailing list
Ip-health@lists.essential.org
http://lists.essential.org/mailman/listinfo/ip-health

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<TITLE>RE: [Ip-health] Thompson DOES NOT Kill Rx =
Imports/Reimports</TITLE>
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<P><FONT SIZE=3D2>This headline is highly innacurate.&nbsp; Thompson =
killed imports/reimports of WHOLESALE quantities of prescription =
drugs.&nbsp; The FDA allows personal use quantities of prescription =
drugs to be carried across the border, and if the Gutknecht Amendment =
passes on the House floor tomorrow (and is ultimately signed into law), =
mail orders of personal use quantities will continue be allowed as =
well.&nbsp; Moreover, if the Sanders Amendment passes, the House will =
have made a strong statement that wholesale importation should be =
allowed as well.</FONT></P>

<P><FONT SIZE=3D2>-----Original Message-----</FONT>
<BR><FONT SIZE=3D2>From: James Love [<A =
HREF=3D"mailto:love@cptech.org">mailto:love@cptech.org</A>]</FONT>
<BR><FONT SIZE=3D2>Sent: Tuesday, July 10, 2001 6:19 PM</FONT>
<BR><FONT SIZE=3D2>To: IP-Health list; pharm-policy</FONT>
<BR><FONT SIZE=3D2>Subject: [Ip-health] Thompson Kills Rx =
Imports/Reimports</FONT>
</P>
<BR>
<BR>
<BR>

<P><FONT SIZE=3D2>-------- Original Message --------</FONT>
<BR><FONT SIZE=3D2>Subject: [RxPolicy] Thompson Kills Rx =
Imports/Reimports</FONT>
<BR><FONT SIZE=3D2>Date: Tue, 10 Jul 2001 15:03:41 -0700 (PDT)</FONT>
<BR><FONT SIZE=3D2>From: Rx Update &lt;RxUpdate@excite.com&gt;</FONT>
<BR><FONT SIZE=3D2>To: RxPolicy@yahoogroups.com</FONT>
</P>

<P><FONT SIZE=3D2>or at least the ability of anyone else to import them =
except pharmaceutical</FONT>
<BR><FONT SIZE=3D2>companies.</FONT>
</P>

<P><FONT SIZE=3D2>-----------------------------HHS PRESS =
RELEASE--SECRETARY THOMPSON</FONT>
<BR><FONT SIZE=3D2>DETERMINES THAT SAFETY PROB LEMS MAKE DRUG =
REIMPORTATION UNFEASABLE</FONT>
</P>
<BR>

<P><FONT SIZE=3D2>UNDEFINED</FONT>
</P>

<P><FONT SIZE=3D2>Date:&nbsp; July 10, 2001</FONT>
<BR><FONT SIZE=3D2>For Release:&nbsp; Immediately</FONT>
<BR><FONT SIZE=3D2>Contact:&nbsp; HHS Press Office</FONT>
<BR><FONT SIZE=3D2>(202) 690-6343</FONT>
</P>
<BR>

<P><FONT SIZE=3D2>Headline:&nbsp; SECRETARY THOMPSON DETERMINES THAT =
SAFETY PROBLEMS</FONT>
<BR><FONT SIZE=3D2>MAKE DRUG REIMPORTATION UNFEASIBLE</FONT>
</P>

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.&nbsp; His findings reaffirm the decision =
made last December by former
 HHS Secretary Donna E. Shalala.

<P><FONT SIZE=3D2>&quot;I believe very strongly that seniors should =
have access to affordable</FONT>
<BR><FONT SIZE=3D2>prescription drugs,&quot; Secretary Thompson said in =
today's letter.&nbsp; &quot;However, I</FONT>
<BR><FONT SIZE=3D2>do not believe we should sacrifice public safety for =
uncertain and</FONT>
<BR><FONT SIZE=3D2>speculative cost savings.&quot;</FONT>
</P>

<P><FONT SIZE=3D2>Reimportation of prescription drugs by pharmacies and =
drug wholesalers would</FONT>
<BR><FONT SIZE=3D2>remove products from the thorough safety and =
effectiveness monitoring</FONT>
<BR><FONT SIZE=3D2>overseen by HHS' Food and Drug Administration, =
Secretary Thompson found.</FONT>
<BR><FONT SIZE=3D2>&quot;Opening our borders as required under this =
program would increase the</FONT>
<BR><FONT SIZE=3D2>likelihood that the shelves of pharmacies in towns =
and communities across</FONT>
<BR><FONT SIZE=3D2>the nation would include counterfeit drugs, cheap =
foreign copies of</FONT>
<BR><FONT SIZE=3D2>FDA-approved drugs, expired drugs, contaminated =
drugs, and drugs stored</FONT>
<BR><FONT SIZE=3D2>under inappropriate and unsafe conditions,&quot; he =
said in the letter.</FONT>
</P>

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.&nbsp; 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.&nbsp; 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.&nbsp; Secretary Thompson's
 finding today, like Secretary Shalala's, concluded =
that neither condition
 could be adequately assured.

<P><FONT SIZE=3D2>&quot;Our drug approval and monitoring system, =
overseen by the FDA, is what</FONT>
<BR><FONT SIZE=3D2>ensures that the American consumer has the safest =
and most effective</FONT>
<BR><FONT SIZE=3D2>pharmaceutical products in the world.&nbsp; It would =
be short-sighted to</FONT>
<BR><FONT SIZE=3D2>compromise that system,&quot; Secretary Thompson =
said.</FONT>
</P>

<P><FONT SIZE=3D2>Today's finding's included:</FONT>
</P>

=B7 Moving from the current &quot;closed&quot; =
distribution system with relatively few
 importers to an &quot;open-border&quot; 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.
 =B7 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.
 =B7 A likely outcome would be a lowering of consumer =
confidence in the safety
 of the drug supply.
 =B7 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.

<P><FONT SIZE=3D2>###</FONT>
</P>

<P><FONT SIZE=3D2>Note: All HHS press releases, fact sheets and other =
press materials are</FONT>
<BR><FONT SIZE=3D2>available at www.hhs.gov/news</FONT>
<BR><FONT =
SIZE=3D2>_______________________________________________</FONT>
<BR><FONT SIZE=3D2>Ip-health mailing list</FONT>
<BR><FONT SIZE=3D2>Ip-health@lists.essential.org</FONT>
<BR><FONT SIZE=3D2><A =
HREF=3D"http://lists.essential.org/mailman/listinfo/ip-health" =
TARGET=3D"_blank">http://lists.essential.org/mailman/listinfo/ip-health<=
/A></FONT>
</P>

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