Senate Agrees To Debate Reimportation Measure
The Senate on Thursday voted 63-28 to invoke cloture, or limit debate, on an amendment to a bill (S 1082) to reauthorize the Prescription Drug User Fee Act that would allow prescription drug reimportation from other nations, Dow Jones reports (Corbett Dooren, Dow Jones, 5/3).
The legislation, which the Senate Health, Education, Labor and Pensions Committee approved in April, would reauthorize PDUFA, which will expire on Sept. 30, through 2012. The bill, sponsored by committee Chair Edward Kennedy (D-Mass.), 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.
The amendment, proposed by Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine), would attach to the legislation a reimportation bill (S 242) that they introduced in January. The bill 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.
The Bush administration has said President Bush would veto the reauthorization legislation in the event that the bill includes the amendment (California Healthline, 5/3).
Despite opposition from Bush, 16 Republicans voted to invoke cloture on the amendment (Armstrong, CQ Today, 5/3). The vote to invoke cloture "cleared the way" for approval of the amendment, according to the Washington Post (Lee, Washington Post, 5/4).
However, approval of the amendment "could have an unintended side effect -- derailing a long-awaited, bipartisan effort to improve" the "faltering system for protecting patients from potentially dangerous medications" at FDA, the Los Angeles Times reports (Alonso-Zaldivar, Los Angeles Times, 5/4).
Before a vote on the amendment, the Senate will consider a second-degree amendment, proposed by Sen. Thad Cochran (R-Miss.), that would require the HHS secretary to certify that reimportation would not pose safety risks and would reduce the cost of prescription drugs.
"Because the administration has said it cannot guarantee the safety of imports, adopting Cochran's amendment would render the importation amendment meaningless," CQ Today reports.
The Senate plans to vote on both amendments on Monday.
According to CQ Today, "some senators who voted for cloture might also support Cochran's amendment," and supporters of the Dorgan amendment "will likely spend the weekend lobbying them not to" (CQ Today, 5/3).
Tony Fratto, a spokesperson for the White House, said, "We support the Cochran amendment. It sufficiently alleviates our safety concerns caused by the Dorgan amendment" (Lopes, Washington Times, 5/4).
Meanwhile, Sen. Judd Gregg (R-N.H.) has asked Senate leaders to allow a vote on an amendment he has proposed that would require FDA to certify online pharmacies and establish systems to ensure consumers who purchase medications online have prescriptions. Gregg said, "Many of these rouge Web sites are based overseas and exercise little to no control mechanisms during the production or verification of (their) products" (Edney, CongressDaily, 5/4).
Sen. David Vitter (R-La.) has proposed an amendment that would require prescription drugs to have "radio tagging" devices, tamper-resistant packages and blister security packages, whenever possible (Alpert, New Orleans Times-Picayune, 5/4).
Dorgan said, "There is a pricing problem with prescription drugs." He added, "The identical drug, FDA-approved, the same pill, put in the same bottle, made by the same company, is set virtually every other place in the world at a lower price. And the American consumer is told, 'You know what, we have a special deal for you: You get to pay the highest price in the world'" (Washington Post, 5/4).
Sen. Bernie Sanders (I-Vt.), who supports the Dorgan amendment, said, "In my opinion, (importation) is more important than the whole bill" (Edney, CongressDaily, 5/3).
Senate HELP Committee ranking member Mike Enzi (R-Wyo.) said, "I'm baffled that we want to take on all the hard work and effort to fix our drug system's problems and then throw it all away opening it up to more drugs." He added, "Let's get it fixed at home before we open it up to the world" (Washington Post, 5/4).
Enzi said, "We've come too far and made too much progress in reaching a bipartisan drug safety bill to allow this dangerous loophole in at the last minute. We all want affordable drugs. But a counterfeit or tainted drug is unsafe at any price" (Newark Star-Ledger, 5/4).
Sen. Richard Burr (R-N.C.) said, "To accept the importation of foreign drugs is to open the door where a cottage industry today becomes a major industry producing counterfeit drugs with no active ingredient."
House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) said that the House version of the bill to reauthorize PDUFA likely would not include a reimportation amendment (CongressDaily, 5/3).
NPR's "All Things Considered" on Thursday reported on the history of PDUFA. The segment includes comments from former FDA Commissioner David Kessler; Alan Goldhammer, deputy vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America; and Jerry Avorn, a professor of medicine at Harvard Medical School (Silberner, "All Things Considered," NPR, 5/3).
Audio of the segment is available online.