Last fall, the FDA got more power and funding to monitor drugs once they're on the market.
by Stephen Cervieri, Managing Director Clinical & Regulatory
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 the "Sentinel Initiative."
Last week, 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, e.g. with WellPoint.
The FDA's current after-marketing surveillance is uneven, as we’ve pointed out. The agency relies on doctors, drugmakers, and patients to report suspected side effects. However, 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. Teasing out which drug might be a problem can be, well, a problem.
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 monitor the situation to see how it plays out.
Regulatory – FTC on the Warpath
The Federal Trade Commission is none too happy with Big Pharma's deal making with generics companies.
As we’ve highlighted, drugmakers are using legal settlements with copycat manufacturers to keep cheaper meds off the market. The FTC believes that what's good for companies in this instance is bad for consumers.
Over the 12 months ended September 30, almost half of the 33 agreements settling patent lawsuits included a restriction on the generic maker's ability to market a drug in return for compensation, the FTC's report said. The agency has sued to block some of these agreements and is supporting a bill in Congress that would ban them.
These sorts of deals have been on the rise over the past couple of years; there were three in fiscal 2005, 14 in 2006, and 14 last year. And the FTC has had only limited success in unraveling them: two appeals courts in 2005 upheld generic-delaying agreements made by Schering-Plough and AstraZeneca.
Clinical and Legal – Expensive to Get In, More Expensive to Get Out
Now there's a device maker considering buying out its deals with surgeons. In a move designed to clear up legal troubles over its contracts with doctors, Zimmer is considering cutting off royalty contracts with many of them. To get out of those long-term deals, the company would give those docs up-front payments. Though Zimmer won't say how much that's likely to cost, analysts estimate the buyouts might run to $250 million.
And that would come on top of a $169.5 million fine levied by the U.S. government last year, plus the $54 million Zimmer expects to spend on new compliance measures, such as disclosing doc payments in an online database.
Legal – Be Careful What You Wish For…
This data leaves me scratching my head. With the general consensus and historical evidence that the Democratic party has been more hostile to (drum roll) BIG pharma… drug and medical device companies, nonetheless are contributing more cash to Democrat candidates.
In this election cycle, Democrats have received $7.4 million. That compares with just $7 million for Republican candidates, according to the Center for Responsive Politics. "Money follows the power," a spokeswoman said. "And it can predict power."
The discrepancy is most obvious in the presidential race. Here are the newest figures: $639,124 for Sen. Barack Obama and $574,828 for Sen. Hillary Clinton, compared with $168,300 for Sen. John McCain.
To be fair, there's more reason to give in the closely contested race for the Democratic nomination; because McCain has had his nomination sewn up for some time, fundraising has fallen off, but likely will pick back up as the general election approaches.
One beneficiary of the increased spending on Democrats: Rep. Frank Pallone, who represents a district in New Jersey which, of course, is home to many of pharma's giants. He's taken in $87,124 from drug and device companies this round. "In the past, I got almost nothing, and many of the Democrats got almost nothing," Pallone said.
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