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
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
"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