FDA, Medicare team up on drug safety

Last fall, the FDA got more power and funding to monitor drugs once they're on the market. Last month, Commissioner Andrew von Eschenbach promised Congress big news on that monitoring, a project that since has been dubbed "Sentinel Initiative." Yesterday, the agency delivered: FDA is teaming up with the Center for Medicare and Medicaid Services on data-mining. FDA will be able to probe CMS's patient databases, actively looking for potential safety problems. Next, the data-mining will move into the private arena via deals with insurance companies; already, the FDA announced a similar partnership with WellPoint [1].

As you know, the FDA's current after-marketing surveillance is haphazard at best [2]. The agency relies on doctors, drugmakers, and patients to report suspected side effects, but often, doctors and patients don't recognize a problem as a drug side effect or simply don't report their suspicions. Since 2005, there's been talk of some sort of data-mining operation, but it's only now coming to fruition.

Not that scrutinizing databases will make for a perfect system. Medicare claims data can be misleading, and Medicare patients use lots of meds--an average of 28 per year--so teasing out which drug might be to blame for a problem can be, well, a problem. Realizing this, FDA is initially going to use the system to get better data on side effects that already are well known.

Another potential problem, for drugmakers at least: The system will most likely boost the number of drug-safety warnings, at least at first. Some of those warnings could be false alarms. CDER chief Janet Woodcock promises to work to minimize that possibility; we'll see how it plays out.

- find the release [3] from FDA
- see the New York Times story [4]
- check out the Wall Street Journal Health Blog item [5]
- read the Los Angeles Times article [6]

Related Articles:
GAO to probe FDA's post-market follow-up [2]
How the FDA will spend your fees [7]
Analysis shows post-marketing studies ignored [8]
FDA to piggyback on insurers' databases [1]