The FDA: ‘A Cautious Animal?’
3 CommentsBy Ed Silverman // March 30th, 2007 // 3:25 pm
Two in two days. What are we talking about? Yesterday, the FDA convinces Valeant Pharmaceuticals to withdraw Permax, a drug for Parkinson’s, along with two generic versions. Today, Novartis is yanking the Zelnorm irritable bowel syndrome, which may reduce painful gas but also holds out the possibility of causing a heart attack. Not a good trade-off.
So during today’s teleconference, an alert journalist asked the FDA’s John Jenkins whether the agency is getting tough on safety. And in an investor note issued earlier, Prudential Equity’s Tim Anderson, wondered the same thing: “What’s next?! The signs that FDA has become a more cautious animal following Vioxx’s withdrawal from the market in 2004 continue to build.”
Now, if this had been Andy von Eschenbach, the high-voltage FDA commish, bureaucratic tongue disorder may have prompted him to seize the moment and cite systems and policies that are making America’s medicine cabinets a safer place in which to stick your hand.
To his credit, Jenkins ‘fessed up. The timing, he allowed, was “coincidental.” The review of Permax, which raised red flags a few years ago, had been going on for “several weeks,” while the Zelnorm data only came to the FDA’s attention on Feb. 22, when Novartis volunteered the info.
By deciding five weeks after receiving the data, however, Steve Nissen of the Cleveland Clinic says the FDA is “acting decisively,” and is feeling pressure from the new Democratic Congress. “We are seeing more prompt action on drug safety,” he suggests.
But just how cautious is the FDA? Permax was low-hanging fruit and Novartis dropped Zelnorm in the agency’s lap. There are, in fact, other tests on the horizon. For instance, will the agency approve Merck’s Arcoxia? Or Dendreon’s Provenge? What kind of Celebrex TV ads will be allowed? For the moment, the FDA appears to be plodding along just as before.
Hat tip to Bob Cohen of The Star-Ledger of New Jersey for passing along Steve Nissen’s remark.[tags]Arcoxia, FDA, Novartis, Permax, Provenge, Zelnorm[/tags]
Laurie
“The review of Permax, which raised red flags a few years ago, had been going on for “several weeks,” while the Zelnorm data only came to the FDA’s attention on Feb. 22, when Novartis volunteered the info. ”
And the last line of this statement says it all…why does the public have to wait for a pharmaceutical company to “volunteer” to provide safety information? You are NOT a regulatory agency if you do not have access to ALL the clinical trial information..until then it is the illusion of safety.
ed
Hi Laurie,
That’s a good point. The FDA’s Jenkins explained the VAERS system, unfortunately, wouldn’t have easily detected this problem.
What’s interesting is that the Swiss regulatory authorities asked Novartis for trial data in 2004, when the warnings were issued for iscehemic colitis. But it wasn’t the FDA that sought the data.
At this point, the agency is reacting to a problem dumpted in its lap. One could argue that if the FDA didn’t do anything in response, that the agency is irresponsible. By taking this action, the theory is that the FDA is responding to pressure. But that’s not necessarily the same thing as being aggressive and assertive. Novartis presented the agency with a problem and the FDA had no choice but to react.
Ed
Laurie
That’s it exactly, The FDA had NO choice, but to react. It’s the same with Vioxx..the FDA only admitted the problem when Merck pulled it off the market voluntarily. Once again…totally ineffective agency.
Now VAERS…is a useless tracking tool. As a nurse of 23 years I had NO idea it even existed until 2004 and this is the case with most nurses. From my experience doctors don’t use it at all because it’s so user unfriendly and time consuming.
So we have an FDA that admits that their tracking tool isn’t accurate AND that they have minimal information about the drugs that they are approving. Consumers will be better served by Google!