Does accelerated approval vitiate the normal requirements for full licensure?
Seems like a more robust clinical trial could and should have been completed over the past couple decades. There’s an obvious benefit to medical abortion, but short term data on hundreds of women isn’t ideal. By now we should have long term controlled trial data on tens of thousands of women. What’s the regulatory argument otherwise?
Without say from the public, meaning the commissioner is not an elected official, the fda will always be in someone's pocket. The commissioner should be a nonpartisan elected person. Elected by the people or maybe by medical doctors. Bottom line, everyone is at the mercy of some person who may be or may not be capable of holding that position; who was placed at that command center by someone who is in someone else's pocket.
I think the FDA needs oversight. The last few years prove that the FDA does not have the American people's welfare in mind when they approve drugs. If it is the courts, then so be it. Perhaps if the FDA knew that if they royally get it wrong, that there will be a court case brought, not against the manufacturers, but against the FDA.
All of those three letter agencies have had their own interests, either $$$ or political at the forefront and the American people have been put in last place as far as priorities go. If their approval process is sound and they follow that process as originally intended, the FDA should not fear the courts, but when they deviate so severely from that process, lives are at stake and there has been little accountability.
The FDA may have been created by laws, but it is an independent organization with its own internal regulatory processes. The courts do not police what every governmental entity does. It is disingenuous to suggest that this is the core issue since the approval occurred a long time ago when the supposed breach took place. Furthermore, judges are not in a position to address clinical matters without proper credentials. VP questions methodology and validity of clinical studies based on his expertise in the issues at hand. It is not ilegal to conduct an imperfect study, just potentially bad science, not bad law.
VP I appreciate your thoughtful and even handed analysis of issues.
Where was the randomized control study that supports this drug? What is the long term safety of this drug to the mother? Courts rule on scientific issues all the time. The burden of proof should be on the drug maker and the FDA to prove their drug is safe and effective. The problem appears to be they know it is not. Why else is the FDA downgrading the reporting and clinical requirements without NEW evidence.
What a great article, VP. I thoroughly enjoyed this. I am with you in the "I need to think about this more" camp. On one hand, it seems the FDA is without accountability. On the other, we don't want partisan judges mucking up everything the FDA does on routine basis.
I think the mifepristone ruling is a pinch different than any other, as the ultimate hinge point to this all is the beginning of life. As a Christian physician, I am wholeheartedly committed to ending elective (convenient) abortion in whatever way I can. I believe that our lives begin the moment that new genetic code is slammed together in the wound (conception). Obviously, not all agree with me. My point?
My fear is, this specific ruling is full of technicalities instead of getting to the "meat" of the argument: the unjustified taking of an innocent life with malice aforethought. It is a slippery slope argument, and it could undermine future challenges to the FDA that are necessary. You mentioned other drugs that needed to be challenged that reached AA. Those are also one slippery-slope argument away from not being able to be challenged, should this mifepristone challenge proves successful.
At one glance, it seems impossible that we would not be able to argue about the inherent value of human life when it comes to cancer drugs and unnecessary vaccines. Then again, just 10 years ago, I would have called you crazy if you had told me my Bud Light can was going to have a man dressed as a woman on it...
While I want to give Ross benefit of the doubt; his warning of subsequent undesirable non-immediate outcome (of judges’ oversight) makes me suspect motive. Doctors threaten parents with non-immediate “child suicide” outcome if patient is denied medical intervention (Trans). The “Warn of non-immediate outcome harm” strategy provides advantage of hiding immediate outcomes from discussion.
The issue here is not whether the judiciary should oversee the, but the problematic political influence. The Texas ruling is ideological in nature and not based on facts. Mifepristone has a 23 year post-market history of safety and efficacy. Kate Shaw's op-ed in today's NYT is worth-reading: https://www.nytimes.com/2023/04/09/opinion/abortion-pill-case-decision.html
As Vinay wrote, “A medical issue/ concern is linked to all downstream consequences,” but that is more than just a slippery slope, and he is correct in wanting to think about it more. In some women, a normal childbirth can cause postpartum depression. Should we then say that a healthy, normal childbirth itself is a serious, life-threatening illness because of this possible downstream effect? And how far downstream are we willing to go? The legal ruling is based on the Accelerated Approval and it’s possible misuse; if the FDA has data showing that the drug is safe and effective, after 23 years, why not just follow the law and grant full approval?
If the FDA can’t be held accountable to the laws that govern them, then why do we have the laws? (Ans: to add checks and balances, and to protect the public.)
“If the legal system cannot say the FDA violated the law in misusing their regulatory authority, who can? Is the FDA unaccountable to anyone who doesn’t work there? That can’t be. Meanwhile, we probably don’t want a system where the only person who can shape the FDA is the commish— who is appointed by the president. We need a system that can say: FDA’s civil servants should have a lot of authority, but when Peter Marks abuses EUA authority to approve a bivalent booster in toddlers who already had COVID19— shouldn’t he be able to be challenged?”
I think this goes much deeper than the ideological motivations that might be at play regarding abortion.
Whatever your stance on abortion, it unfortunately sometimes seems to take controversial issues like this to force the hand of proving the law and process. If it is an opportunity to expose the FDA process and force them to adhere to the law, then THAT alone is an important enough reason to bring the case regardless of the specifics of the matter in my mind.
Thanks for the crisp, clear summary!
Does accelerated approval vitiate the normal requirements for full licensure?
Seems like a more robust clinical trial could and should have been completed over the past couple decades. There’s an obvious benefit to medical abortion, but short term data on hundreds of women isn’t ideal. By now we should have long term controlled trial data on tens of thousands of women. What’s the regulatory argument otherwise?
And let's see the studies confirming that women who use this pill are able to have children in the future. Talk about depression as a side affect!
Without say from the public, meaning the commissioner is not an elected official, the fda will always be in someone's pocket. The commissioner should be a nonpartisan elected person. Elected by the people or maybe by medical doctors. Bottom line, everyone is at the mercy of some person who may be or may not be capable of holding that position; who was placed at that command center by someone who is in someone else's pocket.
I think the FDA needs oversight. The last few years prove that the FDA does not have the American people's welfare in mind when they approve drugs. If it is the courts, then so be it. Perhaps if the FDA knew that if they royally get it wrong, that there will be a court case brought, not against the manufacturers, but against the FDA.
All of those three letter agencies have had their own interests, either $$$ or political at the forefront and the American people have been put in last place as far as priorities go. If their approval process is sound and they follow that process as originally intended, the FDA should not fear the courts, but when they deviate so severely from that process, lives are at stake and there has been little accountability.
The FDA may have been created by laws, but it is an independent organization with its own internal regulatory processes. The courts do not police what every governmental entity does. It is disingenuous to suggest that this is the core issue since the approval occurred a long time ago when the supposed breach took place. Furthermore, judges are not in a position to address clinical matters without proper credentials. VP questions methodology and validity of clinical studies based on his expertise in the issues at hand. It is not ilegal to conduct an imperfect study, just potentially bad science, not bad law.
Leave the FDA and women’s choices alone!
VP I appreciate your thoughtful and even handed analysis of issues.
Where was the randomized control study that supports this drug? What is the long term safety of this drug to the mother? Courts rule on scientific issues all the time. The burden of proof should be on the drug maker and the FDA to prove their drug is safe and effective. The problem appears to be they know it is not. Why else is the FDA downgrading the reporting and clinical requirements without NEW evidence.
What a great article, VP. I thoroughly enjoyed this. I am with you in the "I need to think about this more" camp. On one hand, it seems the FDA is without accountability. On the other, we don't want partisan judges mucking up everything the FDA does on routine basis.
I think the mifepristone ruling is a pinch different than any other, as the ultimate hinge point to this all is the beginning of life. As a Christian physician, I am wholeheartedly committed to ending elective (convenient) abortion in whatever way I can. I believe that our lives begin the moment that new genetic code is slammed together in the wound (conception). Obviously, not all agree with me. My point?
My fear is, this specific ruling is full of technicalities instead of getting to the "meat" of the argument: the unjustified taking of an innocent life with malice aforethought. It is a slippery slope argument, and it could undermine future challenges to the FDA that are necessary. You mentioned other drugs that needed to be challenged that reached AA. Those are also one slippery-slope argument away from not being able to be challenged, should this mifepristone challenge proves successful.
At one glance, it seems impossible that we would not be able to argue about the inherent value of human life when it comes to cancer drugs and unnecessary vaccines. Then again, just 10 years ago, I would have called you crazy if you had told me my Bud Light can was going to have a man dressed as a woman on it...
While I want to give Ross benefit of the doubt; his warning of subsequent undesirable non-immediate outcome (of judges’ oversight) makes me suspect motive. Doctors threaten parents with non-immediate “child suicide” outcome if patient is denied medical intervention (Trans). The “Warn of non-immediate outcome harm” strategy provides advantage of hiding immediate outcomes from discussion.
The issue here is not whether the judiciary should oversee the, but the problematic political influence. The Texas ruling is ideological in nature and not based on facts. Mifepristone has a 23 year post-market history of safety and efficacy. Kate Shaw's op-ed in today's NYT is worth-reading: https://www.nytimes.com/2023/04/09/opinion/abortion-pill-case-decision.html
As Vinay wrote, “A medical issue/ concern is linked to all downstream consequences,” but that is more than just a slippery slope, and he is correct in wanting to think about it more. In some women, a normal childbirth can cause postpartum depression. Should we then say that a healthy, normal childbirth itself is a serious, life-threatening illness because of this possible downstream effect? And how far downstream are we willing to go? The legal ruling is based on the Accelerated Approval and it’s possible misuse; if the FDA has data showing that the drug is safe and effective, after 23 years, why not just follow the law and grant full approval?
Vinay, you have answered the question.
If the FDA can’t be held accountable to the laws that govern them, then why do we have the laws? (Ans: to add checks and balances, and to protect the public.)
“If the legal system cannot say the FDA violated the law in misusing their regulatory authority, who can? Is the FDA unaccountable to anyone who doesn’t work there? That can’t be. Meanwhile, we probably don’t want a system where the only person who can shape the FDA is the commish— who is appointed by the president. We need a system that can say: FDA’s civil servants should have a lot of authority, but when Peter Marks abuses EUA authority to approve a bivalent booster in toddlers who already had COVID19— shouldn’t he be able to be challenged?”
I think this goes much deeper than the ideological motivations that might be at play regarding abortion.
Whatever your stance on abortion, it unfortunately sometimes seems to take controversial issues like this to force the hand of proving the law and process. If it is an opportunity to expose the FDA process and force them to adhere to the law, then THAT alone is an important enough reason to bring the case regardless of the specifics of the matter in my mind.