[Pharm-policy] Public Citizen note on US reimportation vote

[James Love]

Subject: Public Citizen's Prescription Drug Update
   Date: Thu, 20 Jul 2000 14:27:49 -0400
  From: "Roxanne Gillespie" <ROXANNE_GILLESPIE@citizen.org>
 

Senate Approves Drug Reimportation Bill
List of How Senators Voted Is Attached

The drug industry took another hit yesterday as the Senate voted to
approve a drug reimportation bill, allowing wholesalers and pharmacists
to reimport into the U.S. FDA-approved drugs that sell for much lower
prices abroad.  While it is no guarantee that the full cost savings
would be passed on, it is likely that it could put downward pressure on
U.S. prices.       

An amendment to the amendment was also approved that requires  the
Department of Health & Human Services to certify to Congress that
reimportation "(1) pose[s] no risk to the public's health and safety;
and (2) result[s] in a significant reduction in the cost of covered
products to the American consumer."  If HHS can't make this
certification the reimportation amendment would be voided.  We are not
sure whether HHS can make these assurances.

Moreover, the appropriations bill does not provide the tens of millions
of dollars that would be needed to conduct the reviews to make sure that
products are not counterfeit or have not been tampered with.  All of
this is to be resolved in a House-Senate conference.

We have attached in WordPerfect format a summary of how senators voted. 
It's also at: 
http://www.senate.gov/legislative/vote1062/vote_00217.html

The text of the Jeffords amendment is at:
http://thomas.loc.gov/cgi-bin/query/D?r106:2:./temp/~r1066xJQAI::

Below is a summary of the issue from Congress Daily.

------------------------------------------------------------------------------------
Senate OKs Drug Reimportation Bill, But With A Catch

Although a bill to loosen restrictions on the reimportation of
FDA-approved prescription drugs passed the Senate Wednesday, 74-21, it
was amended to include a high hurdle for the Clinton administration. The
amendment would require the HHS to certify it poses no additional safety
risks to public health.
   
The amendment to the FY2001 Agriculture spending bill would allow
pharmacists and drug wholesalers to import lower cost, FDA- approved
prescription drugs from other countries. It also would allow the FDA to
enforce safety laws but provides no additional funds for the agency to
do so.

"It would be very difficult to do [the certification] prospectively, and
the secretary's ability to do so would depend on whether Congress
provides the additional money necessary," said HHS Assistant Secretary
for Legislation Richard Tarplin after the vote.

Tarplin said that while the amendment has addressed the administration's
safety concerns, its success will "hinge on whether the funds are
provided."

The administration's preliminary estimates suggest that tens of millions
of dollars may be needed for the FDA to enforce the provisions of the
amendment, although no new money is provided. The drug industry and
opponents said it would raise serious safety concerns and undermine free
trade.
   
Opponents, such as Judiciary Chairman Hatch, warned against the measure,
saying it could create a "gray market" of questionable drug imports and
flatten efforts of U.S. drug companies to create new products and do
research. "A fake Rolex may be right two times a day, but a fake drug
could kill you,"  Hatch said. And some Democrats who supported the bill
raised concerns that Republicans would use the vote as a way to avoid
passing a prescription drug coverage bill this year.
   
"Republicans who support this drug import amendment but vote against our
proposal to cover prescription drugs under Medicare
are guilty of the worst kind of hypocrisy," said Health, Education,
Labor and Pensions ranking member Edward Kennedy, D-Mass. "This
amendment may have a positive impact on drug prices, but it is no
substitute for a meaningful Medicare benefit," he said.
   
But HELP Chairman Jeffords, the chief sponsor of the amendment,
dismissed that concern. He said after the vote the amendment was just a
"shot across the bow. We've got to get the thinkers at the table to
justify why Americans pay the highest prices."

The amendment, Jeffords said in his statement, is about the equitable
treatment of Americans, particularly those without health insurance. "As
I have said before, this is not the only solution and may not be the
best solution. I strongly believe that we need a prescription drug
benefit in the Medicare system," he said.

Sens. Byron Dorgan, D-N.D., Paul Wellstone, D-Minn., Slade Gorton,
R-Wash., Tim Johnson, D-S.D., Carl Levin, D-Mich., and Richard Bryan,
D-Nev., were cosponsors of the Jeffords' amendment.

The second degree amendment, which requires HHS to certify that there
would be no new safety risk under the Jeffords amendment, was sponsored
by Agriculture Appropriations
Subcommittee Chairman Thad Cochran, R-Miss., and Sen.  Herb Kohl, D-Wis.
The amendment passed 96-0. -- By April Fulton


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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
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