ANN ARBOR — MichBio, the biosciences industry association in Michigan, announced that it will visit Capitol Hill this week alongside other state bioscience and med-tech associations. On the agenda will be a number of significant medical technology industry-related issues such as the medical device tax, FDA user fees and others.
Device and bioscience association delegations from 18 states will converge in Washington, D.C. to conduct coordinated visits on Feb. 29 – March 1 with their Congressional representatives. In addition, there will be a breakfast briefing for directors of state offices about the medical technology industry, federal issues affecting it, and state efforts regarding the ACA and initiatives related to growing the broader bio-industry.
The effort is part of a coordinated advocacy initiative by the State Medical Technology Alliance, a group that operates under the auspices of AdvaMed, the national medical technology trade association. The SMTA organizes annual fly-ins for state associations that represent the interests of the medical device industry. Stephen Rapundalo, president and CEO of MichBio, is the current chair of the SMTA.
“I think it’s important for our Congressional delegation to understand the many challenges facing the medical device industry,” Rapundalo said. “The proposed device tax on revenues will have severe implications for Michigan’s device manufacturers. Major companies like Stryker have already made significant employment cuts pre-emptively simply to prepare themselves for the new tax, let alone the likelihood that smaller device manufacturers will reevaluate their operations and consider moving some offshore to reduce costs. This is a serious threat to medical innovation that will only serve to increase healthcare costs rather than reduce them, as rationalized for the tax.”
The legislative fly-in comes at a critical time for the medical technology industry. Anxiety over the looming device tax is high among manufacturers. The fly-in is meant to help fuel urgency for repeal efforts currently underway. Proposed medical device tax repeal legislation currently has 228 co-sponsors, enough to pass it in the House.
A second issue of relevance to the medical device industry is the proposed new user fee agreement recently negotiated between industry representatives and the Food & Drug Administration. The renewal of the Medical Device User Fee Act or MDUFA, 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. Currently, med tech industry review times here in the U.S. are significantly longer than that in Europe, causing many companies to move their products to foreign markets ahead of domestic patient access.
“A renewal of MDUFA is critical, especially as it spells out pay-for-performance expectations,” Rapundalo said. “The medical device industry badly needs to rely on consistency, transparency and predictability of FDA actions that can enhance new product reviews while insuring patient safety.”