ANN ARBOR — MichBio, the biosciences industry association in Michigan, announced today that it is visiting Capitol Hill Monday and Tuesday. The primary agenda item will be the pending User Fee reauthorizations — Prescription Drug User Fee Act 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 contain.
“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, 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 WeWork for Health Coalition. Joining 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 toMichigan Congressional leaders as we seek their support for industry-critical legislation,” Rapundalo said.
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 health care, 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 www.michbio.org.