She has one of the toughest jobs to keep everyone happy for sure. First off she is asked if the FDA has all the data they need and this leads on to a number of comments and answers. She mentions the Sentinel Data Base created by the FDA and and it has about 159 million patients in the data base to query and look for correlations. This helps identify safety issues. No matter how good the pre-market it, it doesn’t reflect the “real” world and different behaviors will emerge. Electronic Medical Record information in the Sentinel data base is a big help. In 2008 the Sentinel project was started and they did a pretty quick job in putting it all together.
FDA's Sentinel Initiative Will Need to Embrace Mobility Sooner or Later–Better Sooner Than Later–Data Beyond the Desktop
There are 3 parts to the interview and part two continues below. She talks about compounding companies and said the FDA needs to make sure there are systems in place to look for oversight. She states this is a new “gray” area as healthcare has changed.
She says she would like to see a Deputy director for devices to make sure all gets coordinated and they are making progress but things are getting a little more confusing as products are not fitting into the old framework all the time.
She addresses a question on Health IT and she feels it’s an area where the FDA can work with developers on some of the new devices as well as the users to better understand. Some apps need regulatory overview and the area is emerging and new thoughts about regulation are needed and it’s an ongoing process and she talks models. Matthew Herper did a very nice job. Budgets were also discussed and the negative impact that would take place and to that I say tax those data sellers to help fund the FDA and the NIH and then some.
So want more money for research, go where the money’s at to where the data sellers get their data for nothing and profits for free…billions in profit and companies, banks, etc. should not object as the employees of all the entities may need some of this research for treatment or a cure someday.
One More Good Reason to Tax the Data Sellers– Create Additional Funding for the NIH and FDA From Sources That Otherwise Are Too Greedy to Share & Contribute
Panel: A conversation with FDA Commissioner Margaret Hamburg
The Food and Drug Administration regulates a quarter of the U.S. economy, playing a key role in the creation of new drugs and medical devices. How do we balance innovation and safety?