ANN ARBOR, MI--(Marketwire - April 24, 2012) -
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MichBio, the biosciences industry association in Michigan, announced today that it will visit Capitol Hill today and tomorrow alongside other state bioscience associations. On the agenda will be a number of significant biotech industry-related issues such as drug review user fees, modernizing the Food & Drug Administration’s accelerated approval pathway, independent payment advisory board, reimbursement cuts to Medicare, and others.
“I think it’s important for our Congressional delegation to understand the many challenges facing the biotechnology and biopharmaceutical industry sectors,” said Stephen Rapundalo, PhD, president and CEO of MichBio.
The advocacy effort is part of a coordinated initiative by the Biotechnology Industry Organization (BIO) as its Annual Legislative Day Fly-In. Several hundred bio-industry executives and representatives, and dozens of bioscience associations, will converge in Washington D.C. to conduct coordinated visits on April 25 with their Congressional representatives.
In addition, there will be a robust legislative briefing for advocacy attendees, followed by a welcome reception at the Energy & Commerce Committee Room at the Rayburn House Office Building. Rep. Mike Rogers (R, MI-8th) will be honored as BIO’s Legislator of the Year during that reception.
The legislative fly-in comes at a critical time for the biotechnology industry. Anxiety is high among biopharma manufacturers and biotech companies over the reauthorization of the FDA User Fees recently negotiated between industry representatives and the FDA. The renewal of the Prescription Drug User Fee Act or PDUFA will dictate the terms by which companies will pay for their product approval submissions and the timelines by which the FDA must conduct those reviews.
“A renewal of PDUFA is critical, as are the newly proposed Generic Drug User Fee and Biosimilars and Interchangeable Products User Fee, especially as they spell out pay-for-performance expectations. We need reauthorization of the drug user fees so that the FDA can continue to review and approve life-saving therapies In turn, the biopharmaceutical industry needs to rely on consistency, transparency and predictability of FDA actions that can enhance new product reviews while ensuring patient safety,” as indicated by Rapundalo.
MichBio’s visit to Capitol Hill will be busy with a very full day’s worth of meetings with Congressional staffers and elected officials. The biotechnology sector, as part of a broader bioscience industry, is integral to Michigan’s economic vitality, and that message will conveyed loud and clear to Michigan Congressional leaders in the context of current industry issues.
MichBio is the trade association committed to driving growth of Michigan’s biosciences industry. MichBio members include biosciences companies, academic and research institutions, biosciences service providers, and related organizations. For more information, visit www.michbio.org.
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