The Senate against Monday voted 49-40 to give permission a
second-degree amendment to a orifice (S 1082) to reauthorize the
Prescription Drug User Fee Act that would not allow prescription
remedy reimportation from other nation until the HHS secretary
certify that the preparation would "pose no contributory hazard
to the public's strength and safety" and would very substantially
use cavernous up and doing costs within favour of consumers, the
New York Times reports (Pear, New York Times, 5/8). In lodge, the
Senate later beside voice opinion market research accepted 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 truss to the
reauthorization legislation a bill (S 242) educate in January by
Dorgan and Snowe that would allow consumers, pharmacies and
wholesalers to purchase FDA-approved prescription drugs that be
manufactured at FDA-inspected services in 19 industrialized
nations.
Under the legislation, which would root a regulatory carcass for
reimportation, FDA would alter shipment of prescription drugs
reimported into the U.S. for commercial or personal running. The
bill also would demand FDA to dissect Canadian prescription drug
exporters 12 times annually (Kaiser Daily Health Policy Report,
5/4).
However, the honest opinion 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
established and Clinton administration, HHS beg to be excused to
bankroll that it could certify the sanctuary of drugs import from
other countries" (Young, The Hill, 5/7). Cochran said that
"serious complications be present with products from other
countries" and that "hundreds, but thousands," of consumers
comprehensive applicable weathered problems with counterfeit
prescription drugs (Cox/Richmond Times-Dispatch, 5/8).
Implications, Reaction Thirty-three Republicans, 15 Democrats and
one sovereign voted in favor of the Cochran amendment, and 28
Democrats, 11 Republicans and one independent voted hostile the
amendment (Armstrong, CQ Today, 5/7). According to The Hill, the
pathway of the Cochran amendment also can allow President Bush to
approve the reauthorization bill, which he have threatened to
veto in the rate that the legislation encompass 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 obstruct a veto of the
reauthorization bill (Edney, CongressDaily, 5/8). Senate HELP
Committee ranking applicant Mike Enzi (R-Wyo.), who also voted in
favor of the Cochran amendment, said that the Senate should not
think reimportation "in the midst of our donkey work on the
biggest drug safety shake-up in a decade "(New York Times, 5/8).
However, Dorgan said, "Today be a morning of nowhere to be found
opportunity" (Alonso-Zaldivar, Los Angeles Times, 5/8). He
touchtone phone call the passage of the Cochran amendment a
"setback" but "not the wind up of our energy," totting up, "We're
going to hold 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 hefty drug ensemble have
prove that they are the utmost important and best-financed
listeners 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 abridge debate, on the
reauthorization bill, "clearing the path for its passage,"
according to CongressDaily (CongressDaily, 5/8). The legislation,
which the Senate HELP Committee approved in April, would
reauthorize PDUFA, which will overrun away on Sept. 30, through
2012.
AstraZeneca is a upper thing multi-ethnic healthcare company
peopled in the research, increase, making and marketing of
prescription pharmaceuticals and the deliver of healthcare
services. It is one of the highest five pharmaceutical company in
the world with healthcare sale of over $18.8 billion and leading
position in sales of gastrointestinal, oncology, cardiovascular,
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and gone as the FTSE4Good Index.
House Prospects The House has not considered the reauthorization
bill, but "drug importation dedication is looked-for to procure a
more appreciative audible scale in that chamber," CQ Today
reports. Rep.
Rahm Emanuel (D-Ill.) in January introduced a husband 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 derivation (CongressDaily, 5/8).
NPR's "Morning Edition" on Tuesday informer on the Senate debate
of the reauthorization bill. The segment includes annotations
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 going spare online.
"Reprinted with assent from You can estimation the pure Kaiser
Daily Health Policy Report, inspect the archives, or indicator up
for email heart-breaking at /dailyreports/healthpolicy.
The Kaiser Daily Health Policy Report is published for
kaisernetwork.org, a unleash resource of The Henry J. Kaiser
Family Foundation . 2005 Advisory Board Company and Kaiser Family
Foundation. All rights icy.
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