post-marketing

Post-marketing studies are the new norm

Tracy Staton — Fri, 11 Jul 2008 09:22:52 -0400

Have a funny feeling that post-marketing safety studies are more and more prevalent these days? Well, it's not just a feeling. The Tufts Center for the Study of Drug Development found that drugmakers are increasingly bound to study their products after they hit the market--and not only in the U.S., but in Europe and Japan, too.

Over the last decade, in fact, 75 percent of newly approved drugs in Europe and the U.S. and 50 percent in Japan came onto the market trailing a requirement for post-approval studies. "What used to be the exception is increasingly becoming the rule," the study's author said in a statement, adding that post-marketing studies may help identify safety issues earlier and help drugmakers serve patients better.

- check out the release from Tufts
- read the Boston Globe story

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

Public Citizen joins FDA review

Tue, 13 May 2008 06:59:57 -0400

When Cephalon asked the FDA to expand the use of its opioid painkiller Fentora, did it see the shape of things to come at the agency? In Vivo says yes, the "challenging" regulatory environment was on display during last week's advisory committee meeting. In fact, the drugmaker may have faced the embodiment of FDA's apparent caution: Sidney Wolfe, M.D., of the consumer group Public Citizen, a frequent pharma critic, was a "temporary voting member" of the committee hearing the Fentora request.

Agency observers tell In Vivo that Wolfe will be at that table more often in the months to come--and the blog thinks that's a good thing, now that FDA has more post-marketing enforcement tools at its disposal, because Wolfe will push the agency "to use its new tools aggressively." Plus, his presence would be an added stamp of credibility: "If his opinions are built into the standard risk management reviews, then his concurrence should shield the agency (and drug sponsors) from further criticism." We'll be watching this one closely.

- see the item at In Vivo

ALSO: "New" CDER chief Janet Woodcock has been busy weighing in on risk-management plans, too--and trying to figure out how to implement other measures of the FDA Amendments Act, too. Report

Pharma drags feet on promised studies

Thu, 24 Apr 2008 06:59:55 -0400

We once saw a sign in a newsroom that said, "Deadlines, schmedlines, as long as I get paid." Maybe Big Pharma has similar signage posted at its various HQs. According to newly released FDA data, drug makers haven't even started more than 1,000 post-marketing studies they promised to do after their products were approved. And some of that research has been in the promised-but-not-started phase for years. Almost 450 have been on the pledge rolls since way back in 2004.

Now, some of that is the FDA's fault; the agency doesn't always set deadlines for this research. And some drug makers are doing their duties. About 16 percent of post-marketing research was on or ahead of schedule and 14 percent had been submitted to FDA or terminated before completion.

What we're wondering, though, is what FDA will do with its new powers to compel those studies, granted by Congress in the agency funding bill last fall. Will FDA start cracking the whip? Will drug makers shift these studies into high gear? We'll be watching the agency's numbers to find out.

- read the item at Pharmalot

GSK rebuked for missing Avandia reports

Wed, 09 Apr 2008 06:59:58 -0400

GlaxoSmithKline got a trip to the FDA woodshed for failing to regularly report post-marketing data it was gathering on the diabetes med Avandia. GSK failed to include updates on as many as 18 different trials in its annual reports to the agency on that med. The agency rebuked GSK, ordering the company to get its act together pronto.

A Glaxo spokeswoman called the missing reports "inadvertent omissions." But that's just the point, the FDA said. The company lacks a system for making sure the right data gets to the FDA at the right time, the agency said. So what other data on which other drugs is also going unreported? "Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the post market reporting for your firm's other FDA-approved drugs may exist," the letter states. In fact, the FDA only discovered the missing reports when it conducted an audit last fall, in the wake of safety concerns about the diabetes treatment.

And the warning letter isn't a bureaucratic exercise, either--just ask Pozen, one of GSK's development partners. Last fall's FDA legislation gave the agency new post-marketing oversight powers. GSK's letter states that the agency could deny approval of any new Glaxo products until the company corrects its reporting snafus. Speculation that this provision might affect a GSK/Pozen product Treximet sent the smaller company's stock tumbling Tuesday.

- find the FDA warning letter
- read the article in the International Herald Tribune
- see In Vivo's interpretation of the warning
- check out the story in the Wall Street Journal
- get the Pozen news in Forbes

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