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Harkin, Enzi Hail Senate Approval of Bipartisan FDA Safety and Innovation Act

WASHINGTON—Today, Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) of the Senate Health, Education, Labor and Pensions Committee issued a joint statement welcoming Senate passage of the Food and Drug Administration Safety and Innovation Act (FDASIA), bipartisan HELP Committee legislation that would ensure that the FDA can approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America’s global leadership in biomedical innovation:
“Today the Senate proved it could overcome election year politics and partisanship to improve American families’ access to lifesaving drugs and medical devices. The process that led up to today should be a model for Congressional bipartisan cooperation. With input from the biomedical industry, patient groups, consumer advocates, and Democrats and Republicans, our committee assembled a bill that epitomizes consensus and compromise.
“This bill can literally save lives – ensuring that Americans have access to crucial medicines and medical devices.  It will keep patients safer by modernizing the FDA’s inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices.  It will also reduce drug costs for consumers by speeding the approval of lower-cost generic drugs and help prevent and address drug shortages. Finally, by improving the way FDA does business, increasing accountability and transparency, U.S. companies will be better able to innovate and compete  in the global marketplace. This bill’s passage is a victory for the millions of Americans who need medicines or medical devices, and for the kind of bipartisan cooperation that we see all too rarely in Washington.”