Thirty years ago, the median time for the Food and Drug Administration (FDA) approval of a new drug was 33 months. As one can imagine, major backlog at the agency caused significant delay to the approval and entry of potentially life-saving drugs in the market. To address this problem, Congress passed the Prescription Drug User Fee Act in 1992 to authorize the FDA to collect fees when new drug applications were submitted. Those user fees, paid for by the biopharmaceutical industry, supplemented Congressional funding for the agency to review new drug applications in a more timely and efficient manner. Ten years later, Congress passed the Medical Device User Fee and Modernization Act (MDUFA) after the FDA’s medical device program experienced a substantial loss in resources, seeking to accomplish a shared goal (between industry and the FDA) of improving the review process for new medical devices. Read more
Venture capital’s contribution to the technology and Internet sectors are well understood, with VC partnering with the founders of iconic brands like Facebook, Uber, and Netflix. What is not as well understood is how venture is tackling the world’s deadliest diseases and afflictions through the patient investment of capital in life science startups. A prominent example is Genentech, the world’s first biotechnology company, which was founded in 1976 by a venture capitalist and a professor at the University of California, San Francisco. Today, venture is building on past success to solve our nation’s most pressing health care crises, like lymphoma, multiple myeloma, sickle cell disease, cystic fibrosis, multiple sclerosis, and many others.
Small, venture-backed companies play a critical role in bringing groundbreaking medical innovation to market that diagnoses, treats, or cures previously intractable diseases like cancer and HIV/AIDS. These fast-growing and hungry new enterprises are responsible for a considerable amount of breakthroughs in life sciences, so much so that drug companies now rely on acquisitions for three-quarters of their drug pipelines rather than develop new products internally. In many other cases, VC-backed life science startups grow into successful enterprises of their own, with 51 having gone public in 2015. In fact, life science startups drove two-thirds of all VC-backed IPOs in 2015. Read more
NVCA Provides Public Policy Recommendations to House Committee on Energy and Commerce to Address Current Challenges Hindering Medical Innovation
The U.S. venture capital industry has always played a critical role in advancing medical innovation through investment in the life sciences industry, which includes biopharmaceutical, medical technology and diagnostics companies. The life sciences industry has revolutionized healthcare worldwide by preventing or curing serious conditions like influenza and cancer, and transforming once fatal diseases like HIV/AIDS into manageable chronic conditions. Read more
There is immense opportunity in America today to build new technologies, services and products that shape the world. One of our key priorities at NVCA is ensuring America remains a country where the new ideas can flourish and long-term investment in innovation is rewarded. But, an environment that supports entrepreneurship and investment in new ideas cannot be taken for granted.
An economy where innovation can thrive must be carefully cultivated. Everyone in the innovation economy—venture capital investors, entrepreneurs, researchers, students, policymakers, corporations, incubators, service providers and others—has a role to play in advocating for the policies and regulations that provide pathways for innovators to bring new technologies and services to market. Right now, innovators are at a crossroads. If our government can’t bring simplicity and transparency to the regulatory system, America risks losing the entrepreneurs and those who invest in new ideas to Europe, Australia and Asia. Read more
I’m excited to announce that President Obama signed into law on April 1 the “Protecting Access to Medicare Act of 2014,” modernizing the Medicare payment system for clinical lab tests with a market-based payment system. This is an issue that NVCA’s Medical Industry Group has been working on collectively with other stakeholders for several years, and the reforms implemented into law track very closely to what NVCA proposed to Congress in 2008
In summary, the new law creates a new class of Advanced Diagnostic Laboratory Tests defined as sole source multi-analyte tests with a unique algorithm yielding a single result or a test that is cleared or approved by the FDA. Beginning in 2017, new Advanced Diagnostics introduced to the market will be paid at the actual list charge for three quarters before transitioning to the market-based payment system. Additionally, Advanced Diagnostics are eligible for temporary and unique permanent coding, which will take effect prior to January 1, 2016. Read more
As the flood of 2013 recaps and 2014 predictions begins to recede, one storyline continues to spur optimism among venture capitalists: the continued improvement in the venture-backed IPO market. In no sector was this trend more notable than in biotechnology. With 42 IPOs, biotech provided nearly half of the venture-backed total in 2013. In fact, 2013 saw more biotech IPOs than the last five years combined.
Many factors impact the exit environment for venture-backed companies in a given year. But we believe that two NVCA policy initiatives in 2012 helped pave the way for biotech’s resurgence in 2013. The first is the JOBS Act of 2012, which aimed to ease the cost and regulatory burdens faced by small, innovative startups looking to go public. This past year, the average biotech IPO raised $83 million, which is exactly the type of offering that the JOBS Act’s On-Ramp was designed to enable. Read more
Since the day the U.S. Food & Drug Administration (FDA) published its final guidance on mobile medical apps last September, app developers have been trying to determine how the FDA guidance impacts their particular apps and business plans. Now, a consortium of six leading universities, more than a dozen industry trade associations and professional societies – including NVCA, and the FDA are poised to help developers do just that through a series of educational programs called “MMA Roadshow: Managing App Development under FDA Regulation.” Read more