This morning, United States Senator Elizabeth Warren held a roundtable discussion in Boston with U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Stephen Ostroff and members of the Massachusetts Medical Device Industry Council (MassMEDIC). Also in attendance were FDA Center for Devices and Radiological Health Director Dr. Jeffrey E. Shuren, FDA Center for Biologics Evaluation and Research Director Dr. Karen Midthun, and Center for Drug Evaluation and Research Deputy Center Director of Science Operations Dr. Richard A. Moscicki, and Department of Health and Human Services (HHS) Region I Director Rachel Kaprielian. The Senator later held a second roundtable discussion with the FDA and HHS officials and members of the Massachusetts Biotechnology Council (MassBio).
Each year, Senator Warren has invited the FDA commissioner and agency representatives to Massachusetts to hear about the issues important to the biotechnology and medical device communities in the Commonwealth, such as improving the federal regulatory process and strengthening federal investments in the National Institutes of Health (NIH). Similar meetings were previously held regularly by Senators Edward M. Kennedy and John F. Kerry.
"Massachusetts leads the nation in cutting-edge medical and scientific research that keeps families healthy and grows our economy," said Senator Warren. "I'm happy to welcome Acting Commissioner Ostroff and the FDA team to Boston today to continue a conversation about how the federal government can be a strong partner in supporting the important, life-saving innovation that takes place here in our Commonwealth."
"We appreciate Senator Warren's commitment to the tradition begun by Senator Kennedy and continued by Senator Kerry of inviting leadership of the Food and Drug Administration to Massachusetts to meet with life sciences leaders," said Robert K. Coughlin, President & CEO of MassBio, the life sciences trade association representing 650+ member companies and organizations. "We thank Acting Commissioner Ostroff and his team for discussing three of industry's most pressing concerns– the future of the 21st Century Cures effort, the possibilities of the Precision Medicine Initiative, and the implementation of biosimilars across the country. We are encouraged by the efforts the FDA has made to provide guidance and look forward to continuing to work together to bring new treatments and cures to patients around the world."
"MassMEDIC is grateful for the opportunity provided by Senator Warren to continue our dialogue with FDA's leadership. The device industry values these exchanges, as we share the same goals as the agency – expediting the availability of safe and effective medical innovations to patients and health care providers. These initiatives are crucial in keeping the medical device industry growing in Massachusetts and enable our innovative companies–which employ 23,000 people–to create life saving devices," said Thomas J. Sommer, president of MassMEDIC.