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Upton, House Advance Critical Public Health, Jobs Bill

Bipartisan legislation reauthorizes the FDA user fee programs

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Washington, July 12, 2017 | Lynn Turner/Tom Wilbur (202-225-3761/269-385-0039) | comments

U.S. Rep. Fred Upton, R-St. Joseph, today joined colleagues in the U.S. House of Representatives in advancing H.R. 2430, the FDA Reauthorization Act of 2017, by a unanimous vote.

“This bipartisan legislation is about two things: improving public health and jobs,” said Upton. “Now that our groundbreaking 21st Century Cures Act is law, we need to make sure that the FDA is able to handle new breakthrough treatments in a timely and predictable fashion. All while maintaining the highest levels of safety. That’s why these user fee agreements are so important. They’re also important to our economy right here in Southwest Michigan where we have literally thousands of jobs that are affected by this legislation. I was proud to champion this bipartisan legislation that is vital to these good-paying, local jobs as well as patients who will benefit from new therapies it helps get to market.”

H.R. 2430 updates and reauthorizes the Food and Drug Administration (FDA) user fee programs for generic drugs, prescription drugs, biosimilar biological products, and medical devices. These user fee programs ensure companies that develop drugs and medical devices partially pay for FDA’s premarket review of their products. Specifically, H.R. 2430 makes common-sense reforms to the FDA such as facilitating the availability of over-the-counter hearing aids, enhancing generic drug competition to help lower prices, and improving fee structures to help smaller drug manufacturers and small businesses compete. FDA leadership has signaled that without swift enactment of this legislation, they would be forced to lay off up to 70 percent of their employees that approve drugs and devices.

In June, Upton visited with Pfizer Inc’s largest manufacturing site in Portage where company officials expressed support for the legislation.

The programs must be reauthorized by Congress every five years and were last reauthorized in 2012 by legislation sponsored by Upton and signed into law by President Obama.

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