President Obama Warns FDA That Overhaul and Modernization Are Necessary

Mar 01, 2011   

Last week, the Financial Times reported that President Obama has warned the U.S. Food and Drug Administration (FDA) that it will be the target of a major overhaul due to its failure to keep up with advances in medicine and biotechnology. The President specifically mentioned the FDAs process for reviewing medical devices, implying that the process is outdated and in dire need of modernization. (We have previously discussed the controversy surrounding the FDAs medical device review process here and here.)

President Obama made these comments at a panel discussing jobs and the competiveness of the U.S. market. The President stated that his administration will try to make the U.S. economy more competitive by eliminating unnecessary regulatory burdens. During the panel, President Obama emphasized the importance of maintaining regulations necessary for the safety of the public but the need to eliminate regulations that create burdensome, unnecessary hurdles for advances and business.

For the FY 2012 budget, the President has proposed an increase of 33% of the FDAs budget to $4.3 billion. The Presidents complete budget for all of Health and Human Services (HHS), including FDA, can be viewed here.

With the recently passed Food Safety Modernization Act and the FDAs new Medical Device Innovation Initiative, in conjunction with the Presidents demand for the Agencys overhaul, a 33% increase of the FDA budget might not be enough. The FDA is not known for its quick action or adaptability so only time will tell whether these programs will bring about a modernized FDA.