The federal government is closed for the fourth straight day. However, it would be more accurate to say: closed in the DC area. A significant part of FDA is open and has been all week….making this a good time for FDA Matters to acknowledge and explore the growth of FDA in places far from the Washington Beltway. (more…)
Archive for the ‘Planning for FDA’s Future’ Category
FDA’s Growing Presence Outside of the Washington Beltway
Thursday, February 11th, 2010The President’s Budget Request: Is 6% Enough for FDA?
Thursday, February 4th, 2010The President’s FY 11 budget request for FDA includes a $146 million increase in appropriated (non-user fee) funding. This is about 6% of the $2.36 billion appropriation that FDA received in FY 10. With the President’s tough talk about deficit reduction, anything above a freeze should be considered good. Why was the Alliance for a Stronger FDA disappointed? (more…)
A New Food Agency Has Become Unnecessary (For Now)
Friday, January 15th, 2010FDA Matters applauds the appointment of Mr. Michael Taylor to be the first Deputy Commissioner for Foods at FDA. With more authority, experience and stature than any previous food leader, he has the opportunity to shape and re-shape food regulation and the safety of the food supply.
Because Mr. Taylor will be outstanding in this new post, the campaign for a separate food agency will go away, at least for a couple of years. (more…)
FDA Leadership and Challenges: Seven Columns to Re-read for 2010
Sunday, January 3rd, 2010As a rule, FDA Matters does not cover the day-to-day events at FDA and in Congress. Most readers have multiple sources for news about the agency. I doubt I could do better.
Rather, the goal of this blog is to cover larger themes and provide deeper insights into the world of FDA. I place a premium on exploring FDA’s future, as an observer, commentator and instigator. Here are seven columns about FDA leadership and challenges that will help you to better understand the agency in 2010. (more…)
Scientific Reductionism and the End of Medicine
Sunday, December 27th, 2009“For the last 400 years, science has advanced by reductionism … The idea is that you could understand the world, all of nature, by examining smaller and smaller pieces of it. When assembled, the small pieces would explain the whole.” (John Holland).
Have you ever heard someone accused of “reductionist thinking?” You probably will in 2010 because scientific reductionism is a critical, but rarely articulated, foundation of personalized medicine. (more…)
Can FDA Withstand the FY 11 Budget-Cutters?
Sunday, December 6th, 2009Tradition says nothing happens between Thanksgiving and New Year’s Day. People check out mentally and, as often as possible, physically. Not this December, not in Washington, DC.
Most attention is on the US Senate, which is working this weekend and remains under threat of “no days off” until healthcare reform legislation passes. Just as intensely, but much less visibly, the Executive Branch is working full-tilt to complete the President’s Budget Request for FY 11 prior to the State of the Union speech in late January.
Of the two December activities, the President’s budget is far more important to FDA. (more…)
CARS: The Vehicle for FDA’s Future
Sunday, October 25th, 2009Since Labor Day, Commissioner Hamburg has spoken a number of times about the importance of regulatory science. She is right. FDA must have the scientific tools and methodologies to be a 21st century regulatory agency. FDA needs to define regulatory science, develop programs to support it, and package them in a way that will quickly bring recognition and funding. (more…)
The Science Board’s IT Report: Too Technical to Read, Too Important to Ignore
Sunday, October 18th, 2009Some of FDA’s most difficult tasks are: defining the agency’s role in nanotechnology, creating a pathway for follow-on biologics, implementing a risk-based food safety system, and establishing the right policy for “new media” communications.
All rolled together, they are not as complicated or important as transforming information technology (IT) at FDA. (more…)
In Praise of Predictability
Thursday, September 3rd, 2009FDA has always found it challenging to make its actions predictable. This problem will worsen for a number of months while Dr. Hamburg redefines the agency’s mission, policies, actions and working assumptions. Once this has been accomplished, the agency will become dramatically more predictable to stakeholders, including Congress. (more…)
Public Health Leadership at FDA
Sunday, August 23rd, 2009Dr. Hamburg and Dr. Sharfstein have a style and approach that is already distinct from their predecessors. One of my earliest columns, two weeks before Dr. Hamburg’s swearing in, explored why.
I predicted it would take 6 months for the patterns to be clear. We are halfway there, still evolving, and right on track. Do you agree? (more…)