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ENZI CALLS ON LEADER REID TO AVOID HOUSE PLOYS TO MAKE FDA CONFERENCE A POLITICAL POKER GAME


Washington D.C. – U.S. Senator Mike Enzi, R-WY, Ranking Member of the Senate Health, Education, Labor and Pensions Committee (HELP) today said appointing conferees on a landmark FDA reform bill will only play into the hands of House Democrats who have backed away from a commitment to complete work on the measure before the August recess, and urged Majority Leader Reid to insist on an agreement that will preserve the balanced, bipartisan approach reflected in the Senate bill before proceeding to a conference. “It’s clear to me that some involved in these negotiations want to delay this process and raise the stakes by making FDA employees bargaining chips in the process,” Enzi said. “Leaders in the House have made it clear they will not make time to vote on a conference agreement – even if one can be reached before we adjourn – and that they are happy to dangle the threat of layoffs at FDA as the bait to get a better deal in September.” In asking Majority Leader Harry Reid (D-NV) for a delay this morning, Enzi said the appointment of conferees would raise false hopes that progress can be made on a final FDA bill in the next few hours before adjournment when, in fact, the House has no plans to act on the bill before the recess. Reid withdrew his request to name conferees. “We shouldn’t allow the threat of layoffs at FDA and a month of uncertainty during the Congressional recess to scare us into taking a deal that won’t draw the bipartisan support needed to win final approval,” Enzi said. “If we are to answer to the American people, and give FDA the necessary new authorities to better protect the public’s health and safety, we should not be politicizing this process.” “Until the House Leadership is in agreement with our plan, we should not force the issue today by appointing conferees too early,” Enzi added. “If we do this too early, we set ourselves up for the blame game, not for getting this key legislation done. This place should not be about GOTCHA politics when lives are at stake.” In his remarks this morning, Enzi laid out what he believes should be the scope of the conference, saying a final, bipartisan, bicameral bill should include:? Renewal of the “Prescription Drug User Fee Act” and the “Medical Devices User Fee Modernization Act,” which will ensure that nearly 2000 employees at FDA are not laid off;? New authorities to assist the agency in quickly and effectively responding to potential safety issues, including labeling changes, requiring post-market studies to more fully examine potential risks, and to have access to clinical trials information for patients and providers;? New methods to address potential conflicts of interest of advisory committee members to ensure greater accountability and preserve scientific integrity;? Renewal of three key provisions focused on children - the “Best Pharmaceuticals for Children Act” and the “Pediatric Research Equity Act,” which will ensure that drugs used in children are tested on children; and a proposal that would increase our ability to promote medical devices geared toward children. ####