Monday, May 24, 2010

The FDA Spends $72 million to Speed Up Detection of Monitored Product Problems

As reported by CQ Healthbeat News, the FDA has awarded a contract to speed up the detection of product hazards. In a nutshell, the FDA awards $72 million over five years to Harvard Pilgrim Health Care Inc to develop a scaled down version of the Sentinel System. The system meets the requirements of a 2007 law intended to strengthen FDA drug safety oversight.

Forget for a moment the Orwellian program name "the Sentinel System", it's great to see the FDA moving up the timeline in their desire to learn sooner about Adverse Events. However, I find it surprising that they stopped three quarters of the way and didn't go right to the source.

With all of the technology available to be on the bleeding edge of potential Adverse Events (AEs) being discussed by e-patients, the FDA has decided to spend $72 million on examining historical data. For the historians among you, my definition of historical is anything that is not a part of today's conversation.

Now I'm all for data analysis and recognize the importance of this analysis in predicting future trends and being able to highlight the potential for Adverse Events. I further recognize that it is likely the FDA will now be in a position to encounter Adverse Events slightly ahead of where they are now.

However, would it not be much more helpful for the FDA to be in a position to interact directly with the patient and with their explicit permission to learn about potential AEs maybe even before they are reported to HCPs or even submitted for Insurance reimbursement?

The FDA does such a great job relying on crowdsourcing for outreach and dissemination and even data visualization of their recall information. Why does the FDA not recognize the value this same crowd sourcing brings in post market surveillance?

Isn't it time that the FDA truly gets on the cutting edge of these Adverse Events and out in front of where patients go to doctors or file medical insurance claims.

Social Media allows us to conduct post-market surveillance in a real-time setting. We can spot potential problems at the initial mention where individuals are discussing product issues with friends and peers. Was the FDA not listening at its own most recent Part 15 hearing? There were a number of presenters talking about the tools that exists today to discover in real time, that's up to the nanosecond, people who might be experiencing an Adverse Event or just recently experienced one.

For pre and post-market surveillance the crowd of e-patients is ready to assist the FDA in their gargantuan task of protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off radiation.

Do you know any Digital or Social Media monitoring vendors that would like to demonstrate the power of these tools in post market surveillance?

Orginally published on Full Spectrum Blog Jan 21 2010


  1. I think the FDA is up to their ears as is every government department with getting their infrastructure upgraded. DOJ a couple weeks ago had 4 public sites go down and breached.

    Now we will have recalls and everyone needs to get better at what they do, but what do you do when the ship has already sunk? At this point everyone like a solution. I'll give you a link here and it has been very popular and has been on Microsoft Gov and Microsoft MSDN.

    When things happen, like recalls, get a system and one that is simple for doctors and consumers to use:) Here's what I say:

  2. Thanks for your comments. I agree the FDA has a lot to do. Implementing technology and automating processes can help alleviate that load.

    I enjoyed your Microsoft tags in healthcare post. It is possible to read the barcodes that exist on the recalled products now. I agree for the consumer it would be invaluable to have this information widely available. This way customers would know for sure if their version of a drug or device has been recalled or not.