Prescription Drug User Fee Reauthorization Bill could face veto if it contains provisions to allow drug reimportation, Bush Administration says

  The Bush administration on Monday said President Bush would veto a bill (S 1082) to reauthorize the Prescription Drug User Fee Act, which will expire on Sept. 30, in the event that the legislation includes a provision to allow prescription drug reimportation from other nations, CongressDaily reports (Edney, CongressDaily, 5/1). The legislation, which the Senate Health, Education, Labor and Pensions Committee approved in April, would reauthorize PDUFA 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 (Kaiser Daily Health Policy Report, 5/1).

Reimportation Amendment
Sens. Byron Dorgan (D-N.D.) and Olympia Snowe (R-Maine) have proposed an amendment that would attach to the legislation a reimportation bill (S 242) they introduced in January (Young, The Hill, 5/2). 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 (Kaiser Daily Health Policy Report, 3/8).

In a Statement of Administration Policy, the Bush administration said that reimportation would result in the shipment of "unsafe, unapproved and counterfeit drugs" to the U.S. (CongressDaily, 5/1). The statement said that the Bush administration supports the remainder of the reauthorization bill.

Senate Majority Leader Harry Reid (D-Nev.) on Tuesday night filed for a cloture vote on the reimportation amendment. Before the cloture vote, supporters of the reimportation amendment might agree to withdraw the measure from the reauthorization bill in exchange for a separate vote at a later time. Snowe said, "There may be an agreement to consider it separately later this year," adding, "We're prepared to consider it separately if we can get an agreement on it" (Armstrong, CQ Today, 5/1). Dorgan said, "I'm willing to hold off if I get a date certain." He added that the amendment has adequate support to pass (Young, The Hill, 5/2).

Additional Amendments
Sen. Charles Schumer (D-N.Y.) on Tuesday said he would agree not to propose an amendment that would attach to the reauthorization legislation a bill (S 623) he introduced earlier this year with Sen. Hillary Rodham Clinton (D-N.Y.) to allow FDA to approve "comparable" and "interchangeable" generic versions of biotechnology medications through an "abbreviated" process in exchange for a separate vote at a later time (Johnson, CongressDaily, 5/2). I

In addition, Sen. Jim DeMint (R-S.C.) has proposed an amendment that would require FDA to conduct safety studies on the abortion medication mifepristone within a specific period of time, and Sen. Richard Durbin (D-Ill.) has proposed an amendment that would increase FDA oversight of food safety (CQ Today, 5/1). Senate leaders said that they hope to hold a final vote on the reauthorization bill by Thursday, but Republican and Democratic aides said that debate on the legislation likely will extend into next week (CongressDaily, 5/2).

Criticism of Rx Drug Ad Provision
In related news, the Pharmaceutical Research and Manufacturers of America has partnered with broadcast groups and others to try to eliminate a provision in the reauthorization bill that would permit FDA to require pharmaceutical companies to wait two years before they air ads for new medications, the Washington Times reports. The Advertising Coalition -- which includes ad groups, broadcast groups, newspaper and magazine publishers and food companies -- this week in a letter to senators said that the provision would block patient access to important information on medications and violate First Amendment rights.

Billy Tauzin, president and CEO of PhRMA, said, "Direct-to-consumer advertising empowers patients by increasing their awareness of diseases and available treatments. Banning this information -- even for just a couple of years -- is not in the best interest of patients and physicians" (Lopes, Washington Times, 5/2).