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Senior Citizen Politics
Effort by Senate Democrats to Allow Cheaper Drug
Imports Goes No Where
Republican maneuvers keep things they way they are
 May 8, 2007 – The actions in the Senate were wild
and confusing but the final result was the blocking by Republicans of
the attempt by Democrats to allow the reimportation of drugs from outside
the U.S., where they can be purchased much more cheaply. Advocates for
senior citizens, including the AARP, have fought to allow buying drugs
from other countries, in particular from Canada. Many see this as
another victory for the pharmaceutical industry lobby.
Senate Passes Prescription
Drug Reimportation Amendments Allowing Practice, Requiring Safety of
Reimported Drugs to be Certified
The Senate on Monday voted 49-40 to approve a
second-degree amendment to a bill (S
1082) to reauthorize the Prescription Drug User Fee Act that
would not allow prescription drug reimportation from other nations until
the
HHS
secretary certifies that the practice would "pose no additional risk to
the public's health and safety" and would significantly reduce costs for
consumers, the
New York Times
reports (Pear, New York Times, 5/8).
In addition, the Senate later by voice vote
approved an amendment proposed by Sens. Byron Dorgan (D-N.D.) and
Olympia Snowe (R-Maine) that would allow reimportation (Bridges,
AP/Houston
Chronicle, 5/8). The amendment attaches to the
reauthorization legislation a bill (S
242) introduced in January by Dorgan and Snowe that would
allow consumers, pharmacies and wholesalers to purchase
FDA-approved
prescription drugs that are manufactured at FDA-inspected facilities in
19 industrialized nations.
Under the legislation, which would establish a
regulatory framework for reimportation, FDA would regulate shipments of
prescription drugs reimported into the U.S. for commercial or personal
use. The bill also would require FDA to inspect Canadian prescription
drug exporters 12 times annually (Kaiser
Daily Health Policy Report, 5/4).
However, the approval of the second-degree
amendment, proposed by Sen. Thad Cochran (R-Miss.), effectively
"neutralized" the Dorgan amendment, the AP/Chronicle reports (AP/Houston
Chronicle, 5/8).
According to
The Hill,
in "both the current and Clinton administrations, HHS refused to
guarantee that it could certify the safety of drugs imported from other
countries" (Young, The Hill, 5/7). Cochran said that "serious problems
exist with products from other countries" and that "hundreds, if not
thousands," of consumers worldwide have experienced problems with
counterfeit prescription drugs (Cox/Richmond Times-Dispatch, 5/8).
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AARP News Release |
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AARP Welcomes Senate Passage of Rx
Importation, but Promises to Fight Unnecessary Importation
Roadblocks
Looks to House to clear the way for safe,
legal importation of lower-priced prescription drugs
May 7, 2007 - The U.S. Senate today approved an
amendment that would allow for the safe and legal importation of
lower-priced prescription drugs from abroad.
The amendment would legalize the importation of
FDA-approved medications from certain countries beginning with
Canada, impose strict safety standards to prevent drug
counterfeiting, and include important provisions to prevent
potential trade obstructions. The amendment was introduced by
Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME).
"Americans pay among the highest prices for brand
name drugs in the world. Today the U.S. Senate told the
pharmaceutical industry that we will no longer accept this
unfair arrangement where Americans subsidize lower drug prices
for the rest of the world," said AARP CEO Bill Novelli.
Along with the amendment passed today, the Senate
also passed an unnecessary road block intended to prevent the
safe and legal importation of prescription drugs. In a move
designed to block the Dorgan-Snowe measure, language was added
prohibiting importation of prescription drugs unless the
Secretary of Health and Human Services can certify that it is
safe to do so. Despite the fact that safety provisions are
already built into the bill, this provision is designed to give
unnecessary discretion to the Secretary to block importation.
"Pharmaceutical companies already manufacture
prescription drugs all over the world and safely bring them into
the U.S.," continued Novelli. "In 2004, when faced with a flu
vaccine shortage, the FDA was able to arrange the importation of
flu vaccine from the European Union in a matter of weeks.
Further, there are no similar certification provisions in
existence for other products routinely imported into this
country. This poison-pill 'certification' amendment is intended
to do one thing: preserve the status quo and prevent Americans
from having a safe and legal process for accessing lower-priced
prescription drugs.
"A vote for 'certification' is a vote against
safe and legal importation. As part of our ongoing
accountability campaign, AARP will be recording Senators' votes
on both the Dorgan-Snowe and the certification amendments. We
will inform our members about these votes, and how their
Senators voted, Novelli concluded."
The importation of prescription drugs is not the
sole solution to soaring drug prices in the U.S. However, AARP
believes that a system providing for the safe and legal
importation of prescription drugs can serve to put downward
pressure on drug prices and will permit consumers to realize
savings on the cost of their prescription drugs.
The amendments were made to the Prescription Drug
User Fee Act of 2007 (S. 1082). That bill is still being debated
in the Senate and is expected to be voted on in the days to
come. |
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Implications, Reaction
Thirty-three Republicans, 15 Democrats and one
independent voted in favor of the Cochran amendment, and 28 Democrats,
11 Republicans and one independent voted against the amendment
(Armstrong, CQ Today, 5/7).
According to The Hill, the passage of the Cochran
amendment also might allow President Bush to approve the reauthorization
bill, which he has threatened to veto in the event that the legislation
includes the Dorgan amendment (The Hill, 5/7).
Senate Health,
Education, Labor and Pensions Committee Chair Edward Kennedy
(D-Mass.) said that he voted in favor of the Cochran amendment to
prevent a veto of the reauthorization bill (Edney, CongressDaily, 5/8).
Senate HELP Committee ranking member Mike Enzi (R-Wyo.), who also voted
in favor of the Cochran amendment, said that the Senate should not
consider reimportation "in the midst of our work on the biggest drug
safety reform in a decade "(New York Times, 5/8).
However, Dorgan said, "Today is a day of lost
opportunity" (Alonso-Zaldivar,
Los Angeles Times,
5/8). He called the passage of the Cochran amendment a "setback" but
"not the end of our effort," adding, "We're going to keep fighting"
(Wilde Mathews, Wall Street Journal, 5/8).
Sen. Bernie Sanders (I-Vt.), who voted against the
Cochran amendment, called the amendment a "poison pill" for legislation
that would allow reimportation (AP/Houston Chronicle, 5/8).
Sen. David Vitter (R-La.), who also voted against
the Cochran amendment, said, "Well, once again the big drug companies
have proved that they are the most powerful and best-financed lobby in
Washington" (Cohen,
Newark Star-Ledger,
5/8).
Cloture Invoked on Reauthorization Bill
The Senate on Monday also voted 82-8 to invoke
cloture, or limit debate, on the reauthorization bill, "clearing the way
for its passage," according to CongressDaily (CongressDaily, 5/8). The
legislation, which the Senate HELP Committee approved in April, would
reauthorize PDUFA, which will expire on Sept. 30, through 2012.
The bill, sponsored by Kennedy, in large part
follows a proposal that FDA submitted to Congress earlier this year
under which pharmaceutical companies would pay the agency about $393
million in user fees in fiscal year 2008, compared with $305 million in
FY 2007.
The legislation increased the amount in the
proposal by $50 million. According to the
Congressional
Budget Office, the bill, which also includes a number of
prescription drug safety provisions, would cost $547 million over five
years (Kaiser
Daily Health Policy Report, 5/4).
House Prospects
The House has not considered the reauthorization
bill, but "drug importation language is expected to get a more
sympathetic hearing in that chamber," CQ Today reports.
Rep. Rahm Emanuel (D-Ill.) in January introduced a
companion bill (HR
380) to legislation introduced by Dorgan and Snowe that might
become an amendment to the reauthorization legislation, according to a
House Democratic aide (CQ Today, 5/7).
House Speaker Nancy Pelosi (D-Calif.) also has said
that the reauthorization bill might include a reimportation amendment,
according to a congressional source (CongressDaily, 5/8).
● NPR's "Morning
Edition" on Tuesday reported on the Senate debate of the
reauthorization bill. The segment includes comments from Dorgan; Snowe;
Cochran; health care analyst Bob Lashefsky; and Gerard Anderson, a
professor at the
Johns Hopkins
Bloomberg School of Public Health (Rovner, "Morning Edition,"
NPR, 5/8). Audio of the segment is available
online.
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