Just exactly who's in whose pocket these days?
Consider the headline from this week's BioCentury on the new ESA label, "FDA the enforcer."
Authored by the thoughtful and no-nonsense Steve Usdin, the article calls the agency's action, "a dramatic example of how the FDA is willing to use its new powers ..."
And while this isn't a Clark-Kent-Fortress-of Solitude denouement, it is significant -- and as much for the obvious reasons as for some interesting unintended consequences.
The obvious conclusion is that label changes will happen with greater alacrity. An intended consequence of the FDAAA. On this issue, where you stand depends on where you sit. We think it's a good thing because it does away with delaying tactics that served more of a marketing purpose than a public health one. At the end of the day, intelligent people can disagree -- but it's the FDA's job to make the ultimate call.
A less obvious consequence is enhanced transparency in the label discussion process. Usdin writes:
"FDA has been unusually transparent about its interactions with Amgen over ESA labeling in the cancer setting. The agency has released correspondence with the company that describes labeling negotiations, detailed points of disagreement and explained its position in interviews with BioCentury and other news media, and posted redlined copies of the label that highlight changes."
We think that enhanced transparency is a good thing too.
Further, according to Usdin, "The disclosures suggest it would have taken longer to negotiate the changes, and the final language would have been different, in the absence of the new authorities."
Faster? Yes. Different? Maybe. But we now know who wanted what and why. And that's important.
Consider Amgen's statement:
"Amgen has worked closely with the FDA to develop the new label and has no plans to appeal. Although we may have disagreed on specific points, we are pleased that the final label permits physician discretion and recognizes the known benefit:risk profiles of ESAs at this time."
Well, so much for FDA being in the pocket of those it regulates.
We'll give Richard Pazdur the last word (because that's the way he likes it):
"This is a journey and we have not completed it."
Consider the headline from this week's BioCentury on the new ESA label, "FDA the enforcer."
Authored by the thoughtful and no-nonsense Steve Usdin, the article calls the agency's action, "a dramatic example of how the FDA is willing to use its new powers ..."
And while this isn't a Clark-Kent-Fortress-of Solitude denouement, it is significant -- and as much for the obvious reasons as for some interesting unintended consequences.
The obvious conclusion is that label changes will happen with greater alacrity. An intended consequence of the FDAAA. On this issue, where you stand depends on where you sit. We think it's a good thing because it does away with delaying tactics that served more of a marketing purpose than a public health one. At the end of the day, intelligent people can disagree -- but it's the FDA's job to make the ultimate call.
A less obvious consequence is enhanced transparency in the label discussion process. Usdin writes:
"FDA has been unusually transparent about its interactions with Amgen over ESA labeling in the cancer setting. The agency has released correspondence with the company that describes labeling negotiations, detailed points of disagreement and explained its position in interviews with BioCentury and other news media, and posted redlined copies of the label that highlight changes."
We think that enhanced transparency is a good thing too.
Further, according to Usdin, "The disclosures suggest it would have taken longer to negotiate the changes, and the final language would have been different, in the absence of the new authorities."
Faster? Yes. Different? Maybe. But we now know who wanted what and why. And that's important.
Consider Amgen's statement:
"Amgen has worked closely with the FDA to develop the new label and has no plans to appeal. Although we may have disagreed on specific points, we are pleased that the final label permits physician discretion and recognizes the known benefit:risk profiles of ESAs at this time."
Well, so much for FDA being in the pocket of those it regulates.
We'll give Richard Pazdur the last word (because that's the way he likes it):
"This is a journey and we have not completed it."
