New FDA chief receives industry support
Dr Scott Gottlieb, former FDA deputy commissioner, has been confirmed as the agency’s next chief. This comes around four months after Robert Califf, selected by Obama, stepped down.
With a background as an investor, and consultant to the drug industry, some Democrats have criticised Gottlieb’s financial links with the pharmaceutical sector. Conversely, his supporters believe his experience working with pharmaceutical manufacturers will be a key advantage in his new role.
The Los Angeles Time, says Gottlieb is keen to address opioid drug use in the US. He also wants to get prescription drugs to the market faster and that due to his treatment for Hodgkin’s lymphoma, he has become a policy advisor for the National Coalition for Cancer Survivorship which endorsed his nomination as head of the FDA.
President and CEO of the Advanced Medical Technology Association (AdvaMed) Scott Whitaker, is pleased with the appointment.
“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.
“Dr. Gottlieb recognises 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 reauthorisation of the Medical Device User Fee Act (MDUFA) and implementation of the 21st Century Cures Act.”
The California Life Sciences Association (CLSA) has also expressed its support for Gottlieb’s appointment.
The association believes that as the key federal agency responsible for protecting and promoting public health by regulating drugs, medical devices, food safety and other health-related products, the FDA plays a vital role in the development of all biopharmaceuticals and medical technologies. As such, the FDA’s work heavily impacts the pace at which innovation is driven in California’s life sciences industry as well as the delivery of life-changing medicines and technologies far beyond the state of California.
“On behalf of the hundreds of life sciences organisations up and down the state we embody, California Life Sciences Association applauds the confirmation of Scott Gottlieb, 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,” added Radcliffe.
Gottlieb previously served as the FDA’s deputy commissioner for medical and scientific affairs, a position he held from 2005 to 2007. He has also served as a senior policy advisor to the administrator at the Centers for Medicare & Medicaid Services. He is a former member of the editorial staff of the British Medical Journal (BMJ), and a member of the editorial board of the Journal of the American Medical Association (JAMA). Gottlieb is currently a clinical assistant professor at New York University School of Medicine, and a resident fellow at the conservative American Enterprise Institute.