MichBio to Visit Capitol Hill on Pending User Fee Reauthorizations

Mon, 05/07/2012 - 6:45am
The Associated Press



the biosciences industry association in Michigan, announced today that

it is visiting Capitol Hill today and tomorrow. The primary agenda

item will be the pending User Fee reauthorizations -- Prescription

Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) --

as well as the new Generic Drug User Fee Act and Biologics and

Interchangeable Products User Fee Act.

MichBio will join other state bio-industry groups in hosting a

legislative briefing this afternoon on the proposed FDA User Fees. The

session is geared for congressional staffers primarily, but elected

officials are expected to attend. Participants will learn about the

reauthorization of these user fees, resources they will provide to the

FDA, and the regulatory process and performance improvements they


"It's critical that Michigan's Congressional delegation understand the

huge impact these reauthorizations will have on ensuring the timely

approval of new life-saving treatments and devices developed by our

companies, their validated safety, and sustainable FDA operations,"

said Stephen Rapundalo, PhD, president and CEO of MichBio.

The House Energy & Commerce Committee is in the midst of moving the

reauthorization legislation. The Senate Committee on Heath, Education,

Labor and Pensions passed their version of the UFAs legislation a week

ago. The goal is to have full House and Senate approvals by the end of

June and the law signed by the President prior to the summer recess.

This will ensure that the FDA will be able to continue its operations

and product reviews uninterrupted. The renewal of the UFAs will

dictate the terms by which companies will pay for their product

approval submissions and the timelines by which the FDA must conduct

these reviews.

On Tuesday, MichBio will visit Hill offices on behalf of the Michigan

chapter of the We Work for Health


Joining Dr. Rapundalo, who serves as co-chair of the chapter, will be

Coalition representatives from the Michigan Chamber of Commerce and

the state branch of the National Association for Mental Illness.

These meetings come at a critical time for the biotechnology industry.

FDA product reviews are critical for commercialization and business

growth efforts. Companies must be able to rely on clear and

transparent regulations, timely approvals and consistent FDA

performance metrics to satisfy their R&D and market goals. Most

importantly, the new user fee legislation will improve access to

needed therapies and devices, as well as to promote continued

biomedical innovation.

"The broader biosciences industry, with specific relevance to the

pharmaceutical and medical device sectors during this Capitol Hill

visit, is integral to Michigan's economic vitality, and that message

must be conveyed to Michigan Congressional leaders as we seek their

support for industry-critical legislation," said Dr. Rapundalo.

MichBio is the trade association committed to driving growth in

Michigan's biosciences industry and its many sectors, including

ag-biotech, food and nutrition, bio-based technologies and renewable

chemicals, industrial and environmental biotech, medical devices and

equipment, pharmaceuticals and consumer healthcare, diagnostics and

research products, testing and research services, and clinical

research. MichBio members include biosciences companies, academic and

research institutions, biosciences service providers, and related

organizations. For more information, visit

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