Playing FDA parlor games may be fun for some -- but reform of the U.S. Food and Drug Administration must be about serving the public health—not partisan political interests. That’s why I was honored when the Obama FDA transition team called and asked for my advice on how the incoming administration could make the agency a more robust and forward-looking regulatory instrument.
The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best.
My suggested areas of focus are
(1) A strong, science-based FDA
(2) The Reagan/Udall Foundation -- a Partnership of Unequals
(3) Clarity vs. Ambiguity
(4) Information Management
(5) Food Safety and Security
(6) Risk Communications
(7) The Drug Label and the "Safe Use" of Drugs
My complete memo to the transition team can be found here.
There are, obviously, many, many other important issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, etc.) andI look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA. And kudos to the Obama transition team for reaching out to a wide variety of groups. That's the right way to get things done -- despite what some politicians and pundits may think.
The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best.
My suggested areas of focus are
(1) A strong, science-based FDA
(2) The Reagan/Udall Foundation -- a Partnership of Unequals
(3) Clarity vs. Ambiguity
(4) Information Management
(5) Food Safety and Security
(6) Risk Communications
(7) The Drug Label and the "Safe Use" of Drugs
My complete memo to the transition team can be found here.
There are, obviously, many, many other important issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, etc.) andI look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA. And kudos to the Obama transition team for reaching out to a wide variety of groups. That's the right way to get things done -- despite what some politicians and pundits may think.
