FDA’s Woodcock: Safety Is Slowing Things Down
3 CommentsBy Ed Silverman // May 27th, 2008 // 5:09 pm
Who knew? Seriously, though, a new focus on drug safety is, indeed, delaying the approval of some meds thanks to new requirements meant to minimize side effects, Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, confesses to Reuters.
The FDA gained new powers in March to require distribution limits or other restrictions on the sale of new meds. “That’s taking a considerable amount of time more for every application. That will go away in time,” she tells the news service. The process, she continues, is adding days or weeks to reviews of drugs that need the additional safety measures.
She adds that one of her goals is to direct a “major cultural shift” to emphasize safety. “We have to change…We have gotten that message loud and clear from the public,” Woodcock said. But “we are not losing our emphasis on drug development.”
Woodcock also said the agency was concerned about the safety impact of the growing number of clinical trials being conducted outside the US by drugmakers.
Jaynesday
“We have to change … We have gotten that message loud and clear from the public,” Woodcock said.
I applaud the FDA for taking this stand. It is the right and proper thing to do.
However it’s unfortunate that public, private and/or political pressures can sway such a fundamentally important American institution. Our FDA should be strong, consistent and above reproach, not a tool to be used for private leverage.
I’m sorry but it is honestly shameful that the public should have to tell the FDA anything about their approach to their service to us, especially about safety. It is only when an institution has grievously abused our trust in them that such an occasion would be needed.
Now what about the Supreme Court?
Justice in Michigan
As usual, agree with you, Jaynesday. In JW’s defense, I would only say she virtually begged Congress for more resources for drug safety in 2000 and got squat. So, once again, when we critique FDA we should usually also keep track of how Congress and the Exec figure in the mix.
That said, given FDA senior management’s various attempts to turn David Graham into a crouton, it is always “refreshing” to hear them sounding like him.
As far as that other branch o’ gov you mention, don’t get me started ….
Vince
Woodcock view is exactly what is wrong with the FDA. Drug developement “read sales” is her priority. Those familiar with her work realise that both safety and effectiveness are far down on her list .To many drugs approved during her tenure have proven dangerous and have had questions raised about thier effectiveness.