Yesterday marked a significant milestone in the advocacy efforts of NVCA’s Medical Innovation and Competitiveness (MedIC) Coalition as we released on Capitol Hill the results of a comprehensive survey of venture capital firms investing in healthcare. The report, Vital Signs: The Threat to Investment in U.S. Medical Innovation and the Imperative of FDA Reform, revealed that US venture capitalists are reducing their investment in biotechnology and medical device companies and shifting focus overseas to Europe and Asia, primarily due to regulatory obstacles at the Food and Drug Administration.
The report has captured the attention of Congress and we were joined at our press conference by Senator Michael Bennet (D-CO), Senator Richard Burr (R-NC) and Representative Michael Burgess (R-TX), all of whom showed strong bi-partisan support for meaningful FDA reform which demonstrates a commitment to innovation. We also were joined by Margaret Anderson, Executive Director of FasterCures, an organization whose mission is to accelerate the progress of discovery and development of new medical solutions for deadly and debilitating diseases.
Our report follows on the heels of an FDA Report released Wednesday, Driving Biomedical Innovation: Initiatives for Improving Products for Patients, which summarized steps that the agency has been taking to improve approval processes. While we are heartened to see the FDA is now focused on an innovation agenda, we continue to assert that words are not enough and we must begin to see real action. Senator Bennet agreed yesterday stating:
“At a time when our drug, biotechnology and medical device startup companies are struggling to access capital in this economy, we must strive to provide them with regulatory clarity and predictability in a way that is safe for patients but also helps foster innovation….. The FDA has taken steps towards this. I was pleased to see their Innovation Initiative yesterday. But we have to do more and expect more for our patients and the people who spend their lives trying to help them.”
In conjunction with the press conference, NVCA/MedIC members spent significant time on Capitol Hill this week meeting with members of Congress and top Administration officials on the survey and its recommendations. These recommendations include a well resourced FDA that is sharply focused on improving the predictability, clarity and transparency of the approval process as well as one that is committed to a culture of innovation. There is a growing groundswell of bipartisan and bi-cameral support for change, and we plan to carry this momentum forward in the coming months. The ramifications of inaction, as the study suggests, are far too concerning. We must take immediate steps or we risk harming patients and losing our leadership position in medical innovation and economic growth.
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