FDA Bill Moves Quickly Through The Senate

The Senate overwhelmingly approved a bill today that will help ensure that Americans have access to crucial medicines and medical devices. The bill is also a model for how legislation is supposed to be done according to U.S. Senator Mike Enzi, R-Wyo., the top Republican on the Health, Education, Labor and Pensions (HELP) Committee.
Enzi said the Food and Drug Administration (FDA) User Fee Reauthorization bill, S.3187, will help the FDA more efficiently approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America’s global leadership in biomedical innovation.

“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,” said Enzi. “This is why the committee process is so important. By bringing together Republicans and Democrats, industry leaders and advocacy groups, we were able to put together a truly bipartisan bill that is non-controversial and reflects input from everyone.”

Enzi said the bill 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.

The bill will also improve the way FDA does business, increases accountability and transparency, and will help U.S. companies to innovate and compete in the global marketplace, according to Enzi.

The Senate approved the bill by a vote of 96-1.