Amendment To Permit Rx Drug Reimportation Nullified in Senate
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 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 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 (California Healthline, 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).
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).
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).
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 (American Health Line, 5/4).
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.