The Senate?s procedural vote this morning on the Dorgan prescription drug importation amendment is of serious concern. This amendment fails to sufficiently ensure the safety of imported products, and would open the door for counterfeit drugs to enter our domestic pharmaceutical supply. It would imperil the Food and Drug Administration?s (FDA) ability to protect American consumers from counterfeit and diverted drugs.
Allowing the importation of drugs outside the current safety system would pose an immediate and significant risk to the public health in the United States.
Additionally, the potential inclusion of this politically controversial amendment in the Food and Drug Administration Revitalization Act threatens the timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee and Modernization Act (MDUFMA). These programs play a critical role in FDA?s ability to ensure the safety and efficacy of the medical products on which the American people rely. In the event the Congress were not to reauthorize these programs, FDA would lose user fee revenue that provides roughly one-quarter of its annual operating budget, and would be required to eliminate more than 2,000 jobs supported by PDUFA and MDUFMA.
The Statement of Administration Position (SAP) on this legislation articulates the Administration?s strong opposition to any provision that could delay these programs? timely reauthorization. Furthermore, the SAP states that the President?s senior advisors would recommend he veto the bill if, when presented to the President for signature, it included any provision that permits the importation of prescription drugs without addressing the serious concerns identified in the December 2004 Department of Health and Human Services Task Force Report on Prescription Drug Importation.
In the interest of both the health of the American people, and the timely reauthorization of PDUFA and MDUFMA, I strongly encourage the U.S. Senate to pass an FDA bill that does not contain drug importation language like the Dorgan amendment.