The Right Person for the Job:  FDA Commissioner Hamburg Appoints New Leadership

As we continue to advocate for increased funding and improved specialized review divisions at the FDA, we are encouraged by the recent positive action coming from the Commissioner’s Office.  Commissioner Hamburg has reorganized the top level of the Agency.  We applaud her decision to appoint Dr. Stephen P. Spielberg to the new position of Deputy Commissioner for Medical Products and Tobacco.  Spielberg will provide high-level coordination and leadership across the Centers for drugs, biologics, medical devices, and tobacco products.  The Centers will remain as discrete management entities under their current expert leadership.

Spielberg, a distinguished physician and researcher, was most recently the Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City.  Prior to that, Spielberg was the dean of Dartmouth Medical School and vice president for health affairs at Dartmouth College.  He also spent 11 years in the pharmaceutical industry, working for Merck and then Johnson & Johnson, as vice president for pediatric drug development.  Having a qualified executive who understands the drug development process is an important first step in improving the regulatory process.  Additionally, his work with personalized medicine should make him an advocate for accelerating treatments for rare diseases, as personalized medicine faces similar regulatory challenges.

Facing increasing concern from industry, patient organizations and Congress that the FDA’s drug and device approval process has become so slow, costly and unpredictable that it is actually stifling innovation, Commissioner Hamburg appears to be making productive and forthright changes to address these concerns.

The Foundation supports a plan that will provide additional funding for the FDA in order to create more specialized review divisions, provide increased academic connections for senior review staff, and establish increased access to accelerated approval for rare diseases.  We hope the Commissioner and Spielberg will continue to make the bold changes that are needed to improve the regulatory process and bring life-saving treatments to patients.  For more information about our efforts go to CureTheProcess.org.

X