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News & Analysis | REG•WATCH Blog | Press Room
Wednesday, May 02, 2007
Drug Importation Could Derail PDUFA Reauthorization
Yesterday, Reg•Watch blogged about the various amendments to the Senate PDUFA reauthorization bill. An additional provision has become the subject of political wrangling.
Sens. Byron Dorgan (D-ND), Olympia Snowe (R-ME) and Chuck Grassley (R-IA) support a provision which would allow importation of drugs from Canada and the European Union. Yesterday, OMB released a statement indicating the president would likely veto PDUFA reauthorization if it included such a provision.
The White House argues importation poses a safety concern: imported drugs are not subject to FDA approval. Even if we excuse the recent litany of FDA screw-ups (too many to list on this blog), the White House's concerns are misplaced. Americans deserve access to basic drugs from countries with excellent safety records. Importation would save consumers money and stoke competition in the American pharmaceutical market.
What's really startling is Bush's veto threat. PDUFA reauthorization is considered must-pass legislation. PDUFA expires in September and the funds it provides FDA are necessary for the agency to operate. Moreover, the bill currently carries other provisions which would strengthen FDA's ability to regulate. With its usual bravado and contempt for bipartisanship and good governance, the White House would be willing to derail the bill thereby hindering FDA's operations severely.
For now, it seems as though Senate Democrats are willing to get on board with the White House. Dorgan has indicated he will consider withholding the amendment if he is promised an opportunity to introduce it at a later time. Unfortunately, if the drug importation provision is not attached to the must-pass PDUFA reauthorization, it will face a much more difficult track in Congress.
Reg•Watch Update:
Posted by Matt Madia
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