FDA to post drugs with “potential safety issues” on website
Leave it to the FDA to approach an issue as critical and immediate as drug safety with a half measure completed at a frustratingly glacial pace. But hey, that’s a bureaucracy for ya. And I suppose I should give my old adversaries at the FDA credit for at least taking a step (albeit a tiny one) in the right direction.
The FDA has finally begun to post on its website a list of all the drugs that it is evaluating for potential safety issues. “If a drug appears on a quarterly report, it means we have begun analysis to determine whether it’s a safety problem that requires further evaluation,” said the FDA’s director of the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Dr. Gerald Dal Pan.
Sometimes it sounds as though the FDA spends at least as much time naming it’s departments as it does monitoring new drugs, doesn’t it?
Some of you may say, “This is good – this is public knowledge, and the FDA is putting it out there for the public to use.” Well, you’re half right.
But I don’t believe this move goes nearly far enough. As I’ve mentioned, this is just a half measure. These are quarterly reports that are posted – which means the site is only updated four times a year, once every three months, if that.
The current list posted by the FDA covers drugs placed there between January and March of 2008 – and I’m writing this in September! By my calculations, an updated list was due back in July. According to Dal Pan, drugs under investigation before 2008 or after March of this year AREN’T INCLUDED ON THE CURRENT LIST! And Dr. Dal Pan said he wasn’t sure when an updated list would be posted.
But when it comes right down to it, it’s all for show anyway. While the list will name the drug and the potential problems that are associated with it, it will stop short of giving critical details. The list will NOT mention the extent of the potential safety issue, nor will it reveal how many reports of adverse reactions have been filed.
Now does that last little detail sound like it’s designed to protect consumers or pharmaceutical companies? I’ll let you draw your own conclusions.
I find it rather amusing that after all this hullabaloo, Dr. Paul Seligman, from the FDA’s Center for Drug Evaluation Research, emphasized that people should not “overreact” if a drug that they’re taking appears on the list, and stop taking that drug.
“We are expecting people not to take actions simply based on the fact that we are evaluating a particular drug,” Seligman said.
Which begs this question: if you’re not supposed to take measures to defend yourself against the “potential safety issues” of a drug under investigation, then why is the FDA making such a big deal about posting the drugs that are under investigation on the agency’s website?
Does this whole thing sound like a massive cover-your-behind operation by a bloated and inefficient bureaucracy to you?
If you want to check out the drugs currently on the outdated list that may or may not be updated in the future, go to http://www.fda.gov/cder/aers/potential_signals/potential_signals_2008Q1.htm
