Breaking News

Industry Offers Support for Gottlieb Confirmation

By Sean Fenske, Editor | May 10, 2017

Dr. Gottlieb previously served as the FDA’s deputy commissioner for medical and scientific affairs.

On May 9, 2017, Dr. Scott Gottlieb was confirmed to serve as commissioner of the U.S. Food and Drug Administration. A former member of the agency, having previously served as the FDA’s deputy commissioner for medical and scientific affairs, Dr. Gottlieb enters the position with a good understanding of the agency’s role as well as the political landscape of Washington. Pressing issues for the medical device sector that he will help to shape include device user fees and implementation of the 21st Century Cures Act.
 
A number of leading medtech associations offered congratulations and words of support for the confirmation.
 
“MDMA congratulates Dr. Gottlieb on his confirmation as the next FDA commissioner and looks forward to working with him to achieve our common goals of improving patient care and spurring medical technology innovation,” said Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA). “While the regulatory environment has improved over the years, we know that there is more work to do to establish reasonable and predictable pathways for the next generation of medical devices. Patients and providers continue to search for solutions to the pressing needs facing the health care system, and med tech innovators are working to develop the cures and therapies that they desperately need.”
 
“MDMA and our members are committed to working closely with Dr. Gottlieb to ensure that the United States remains the global leader in medical technology innovation, and that our industry can build upon our proud track record of alleviating human suffering and saving lives,” he concluded.
 
“On behalf of AdvaMed, I’d like to congratulate Dr. Gottlieb on his confirmation as FDA commissioner. His previous experience at FDA as well as his time at CMS make him uniquely qualified to lead this vital agency,” offered the Advanced Medical Technology Association’s (AdvaMed) president and CEO Scott Whitaker. “Dr. Gottlieb recognizes the crucial role of medical technology in solving some of our nation’s most daunting health care challenges and the importance of a strong, efficient and predictable FDA in ensuring continued patient access to safe and effective medical innovations.”
 
“We look forward to working with Commissioner Gottlieb and his team on efforts to improve the FDA review process as well as reauthorization of the Medical Device User Fee Act (MDUFA) and implementation of the 21st Century Cures Act,” he added.
 
“On behalf of the hundreds of life sciences organizations up and down the state we embody, California Life Sciences Association applauds the confirmation of Scott Gottlieb, M.D., as FDA commissioner. Over the span of his distinguished career, Dr. Gottlieb has a proven track record as a strong advocate for both protecting public health and promoting biomedical innovation,” said Sara Radcliffe, president and CEO, California Life Sciences Association (CLSA). “More recently, Dr. Gottlieb’s prominent and respected participation on several public health and policy committees, including the Federal Health IT Policy Committee and the National Coalition for Cancer Survivorship, further confirm the breadth and depth of his experience and commitment to bringing life-saving innovations to patients in need. During his previous time at the FDA as a deputy commissioner, Dr. Gottlieb was a strong advocate for policies that supported an efficient and streamlined drug development and approval process, including supporting development of the Critical Path Initiative. With his experience in regulatory matters, and understanding of agency and industry needs, we are confident Dr. Gottlieb will be an exemplary leader for the FDA. We look forward to working with him and his team at the FDA to meet our shared goals.”
 
“BIO congratulates Dr. Scott Gottlieb on his confirmation as commissioner of the FDA, a position for which he is eminently qualified and which carries immense responsibility in protecting and promoting the health of all Americans,” said Biotechnology Innovation Organization (BIO) president and CEO Jim Greenwood. “The opportunities facing the agency today are tremendous. We are confident that Dr. Gottlieb’s confirmation will provide the agency with the stability and leadership needed to fully harness the tools of modern drug development and to better incorporate patients’ perspectives into the agency’s regulatory processes.”
 
He concluded, “We look forward to working with Dr. Gottlieb to ensure that the FDA has the necessary staff, resources, and flexibility required to keep pace with the marvelous advances taking place in the fields of biomedical, agricultural, and animal biotechnology.”
 
  • Loading Orthopedic Devices with Biologics and Pharmaceuticals

    Loading Orthopedic Devices with Biologics and Pharmaceuticals

    Dr. Kevin Nelson, Founder and CSO, TissueGen Inc.||May 19, 2017
    Fiber technology enables the delivery of the therapeutic components via a biodegradable platform that can be implanted.

  • Looking Beneath the Surface

    Looking Beneath the Surface

    Sam Brusco, Associate Editor||May 19, 2017
    Surface treatments seek to improve orthopedic device usability, longevity, and bone integration.

  • Going to Extremes

    Going to Extremes

    Michael Barbella, Managing Editor||May 19, 2017
    The innovation and market value found in extremity solutions is prompting a change of heart among major orthopedic firms.