U.S. FDA Deputy Commissioner Outlines Principles in Keynote Address at PDA/FDA Meeting 23 September, 2009

Bethesda, Md. – U.S.  FDA Deputy Commissioner Joshua Sharfstein, MD, previewed what direction the Agency’s public health policies will take under new Commissioner Margaret Hamburg, MD, during his keynote address at the 2009 PDA/FDA Joint Regulatory Meeting in Washington, D.C. on September 14.

Sharfstein presented four principals that will guide FDA’s new approach: prevention, best available science, transparency and that the idea of the premise of public health is that what matters is the health of the public.

“In evaluating product quality issues for 2020, I would imagine there are many potential ways to resolve key challenges—I urge you to consider the health of the public as the North Pole for your compasses.”

He noted the importance of partnering with the agency to better serve the public and advised PDA members to tap into the resources available at FDA to further innovative efforts. “We hope to see many productive and creative efforts where the agency can share its knowledge and expectations, and we can foster a new generation of safe and effective medical products for the American people.”

Sharfstein said that he and Dr. Hamburg were “impressed” with “efforts involving the International Conference on Harmonisation, global regulators and industry.” He said, “the goal of these efforts is to understand from the start what makes a product of high quality … rather than waiting to discover that after the fact.  We would like to foster more such productive collaborations that lead to concrete results in preventing problems.”

Earlier in his speech, Sharfstein told members that, “at FDA, Dr. Hamburg and I understand that product quality issues also rest on a base of  regulatory science.” He said that the Commissioner is encouraging leading scientists at the Agency to identify “key projects that, if supported, can improve product quality and streamline approval pathways—making them at once quicker and more reliable.”

After his keynote address, the Deputy Commissioner participated in a press conference, where members of the trade press were present.

For the complete transcript of Sharfstein’s remarks go to http://www.pda.org/pdafda2009