Tuesday, May 08, 2007 Capitol Hill
Watch
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).
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.