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?
Tags: Adverse Events, FDA
No doubt social media will be used for AE reporting and data collection. No one quite knows how to do that yet nor is it clear how to separate the wheat from the chaff, the good from the bad, the real from the fake etc. These will presumably be primarily or entirely non-health care professional reports which are often (but not always) not too useful especially since the terminology is not clear when used by non-medical folks. Stroke can mean heat stroke or cerebrovascular infarct etc. But all of this will work itself out over time and the techniques will be developed to get the useful and real data. So yes I sort of agree that more $ should be spent on modernity. The vendors will get their act together and start proposing methodology or in fact, just using it and then the regulators will be forced to respond (that’s the usual way life works). In defense of the historical look, there are two justifications that strike me as ok: 1) this is being used on historical data to validate techniques to be used in the future and 2) one of the programs (IMPACT) is being done to see if the current spontaneous reporting system is, in fact, worthwhile doing and continuing – not a bad thing if this done objectively. Maybe the whole system should be scrapped. We’ll see.
Thanks for your comment Bart. It’s clear that we are venturing into the unknown here and that we are at the tip of a steep learning curve. I agree that it is a worthwhile venture and since there is no one doing it out there think its time someone starts. This is why I have put a call out to listening vendors to work with on the beta project. I’m not sure what changes will be needed but I’m all for spending money on modern tools especially if it can be shown they will improve the FDAs ability to acheive its 2007 mandate.