FDA, Medicare team up on drug safety

Tracy Staton — Fri, 23 May 2008 09:40:39 -0400

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.

As you know, the FDA's current after-marketing surveillance is haphazard at best. 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 from FDA
- see the New York Times story
- check out the Wall Street Journal Health Blog item
- read the Los Angeles Times article

GAO to probe FDA's post-market follow-up

Wed, 05 Mar 2008 06:59:58 -0500

The government's own watchdog will soon be sniffing around FDA drug approvals and FDA-ordered post-marketing studies. Prompted by Sen. Charles Grassley, the Government Accountability Office plans to investigate the practice of using biomarkers such as blood sugar in diabetics and cholesterol levels among those at risk of heart disease, in evaluating efficacy. These measures are used in drug trials in part because assessing actual outcomes like heart attacks and strokes requires years-long studies that cost megabucks. If the FDA required pre-approval outcomes studies, new drugs would come to market even more slowly than they do now. And development costs would skyrocket.

Lately, though, biomarkers have become controversial as safety and effectiveness questions arose about meds such as GlaxoSmithKline's Avandia. That drug was approved because it lowered blood sugar, which docs believe will in turn cut the risk of heart attack. But a study last year showed that Avandia might actually increase heart-attack risk. Then, early this year, a major trial of Merck and Schering-Plough's cholesterol med Vytorin showed that it did a better job of lowering bad cholesterol than a generic statin did--but it did no better at preventing plaque buildup in patients' arteries. So in these cases, long-trusted biomarkers were called into question, and some experts contended that the FDA shouldn't OK a product without real outcomes studies.

Now, the GAO has agreed to weigh in on the subject. Sen. Charles Grassley (R-IA) asked the watchdog to investigate. His point: If the FDA uses biomarkers to approve a drug, then it needs to enforce its own calls for post-marketing outcomes studies, so-called Phase IV trials. Is the FDA doing so? According to a 2006 Health and Human Services investigation, no; at the time, the FDA couldn't even readily identify which companies had made progress on those studies and if so, how much. Recently, the FDA said that of 1,200 of the studies it had required 900 hadn't even begun.

Under a new law, FDA can fine companies up to $1 million for failing to perform those studies. But is $1 million an adequate punishment? Grassley has argued for higher fines, and in his request to the GAO, asked whether FDA needs more authority to compel the studies. All we can say is, if the FDA got all the power and money its critics say it needs these days, it would be formidable indeed.

- check out Grassley's release and letter to the GAO
- read the AP report

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post-approval marketing

FDA, Medicare team up on drug safety

GAO to probe FDA's post-market follow-up