NVCA And MedIC Coalition Applaud Senate And House Passage Of FDA User Fee Reauthorization Bills

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Passage Demonstrates Bipartisan, Bicameral Support for U.S. Medical Innovation

The National Venture Capital Association (NVCA) and the Medical Innovation and Competitiveness Coalition (MedIC) today commended both the U.S. Senate and House of Representatives for the swift and strong bipartisan passage of corresponding bills which sets the stage for a stronger, more efficient Food and Drug Administration (FDA) going forward. The Senate bill (S.3187), which passed on May 24, 2102, with a vote of 96-1 and the House bill (H.R. 5651), which passed yesterday with a vote of 387-5, will now go to conference and be presented for a final vote in both chambers in the coming weeks. President Obama has also indicated support for S. 3187 which includes a number of important provisions long supported by NVCA and MedIC for advancing medical innovation in the United States.

“Throughout these deliberations, Congress has demonstrated a keen understanding of the importance of bringing the most advanced and innovative medical breakthroughs to American patients safely and expeditiously, “ said Jonathan S. Leff, managing director at Warburg Pincus and chairman of the MedIC Coalition. “We are encouraged not only by this bipartisan Congressional backing but also by support from the administration and FDA leadership for important provisions designed to help maintain our country’s competitive edge in medical innovation.”

Both the House and the Senate bills carry very similar provisions and will raise $6.4 billion in user fees for the FDA over five years. Included in both pieces of legislation are a number of NVCA and MedIC priorities including:

  • Expanding the accelerated approval process to new medical treatments;
  • Creating a new pathway for breakthrough therapies;
  • Providing incentives for antibiotic development;
  • Improving the FDA’s advisory committee conflict of interest rules;
  • Clarifying the least burdensome standards for medical devices;
  • Modifying the De Novo application process; and
  • Accelerating the appeals process for medical devices.

“S. 3187 also includes a risk-benefit framework for the drug approval process that will provide a more consistent and balanced approach to FDA’s decision making,” said Mark Heesen, president of the NVCA. “We look forward to the benefits that will be realized by patients as our country’s most exciting life science startups move forward under a more transparent and efficient approval process in which both safety and innovation are strongly considered.”

About NVCA

Venture capitalists are committed to funding America’s most innovative entrepreneurs, working closely with them to transform breakthrough ideas into emerging growth companies that drive U.S. job creation and economic growth. According to a 2011 Global Insight study, venture-backed companies accounted for 12 million jobs and $3.1 trillion in revenue in the United States in 2010. As the voice of the U.S. venture capital community, the National Venture Capital Association (NVCA) empowers its members and the entrepreneurs they fund by advocating for policies that encourage innovation and reward long-term investment. As the venture community’s preeminent trade association, NVCA serves as the definitive resource for venture capital data and unites its more than 400 members through a full range of professional services. For more information about the NVCA, please visit http://www.nvca.org.

About MedIC
Comprised of National Venture Capital Association member firms and their life sciences portfolio companies, the MedIC coalition advocates for policies and regulations that advance and support U.S. medical innovation. MedIC seeks to 1) educate policymakers on the critical role America’s medical innovation plays in the U.S. healthcare system, 2) establish incentives for investors and entrepreneurs to drive medical innovations in the U.S. and 3) achieve broad based FDA reform so that breakthrough technologies can be brought to market more efficiently. More information on MedIC can be found at medic.nvca.org.

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