The FDA solution to who should fund RCTs of fast tracked drugs fails to address the root cause: pharmaceutical industry pushing to get their drugs, some for rare diseases, out with minimal data. Califf is in synch with the Biden Administration’s bandaid solution of problems like the tuition forgiveness plan rather than looking at why higher education is so expensive.
Califf is a tool, nothing more, as evidenced by his Pom Pom girl tweets that echo non evidence based pronouncements.
They've gone from a post-truth mentality (e.g., "What's good for your good isn't necessarily good for my gander") to a truth-irrelevance mentality ("I don't care what the truth is, THIS is the way I'm going to lead"). Seems fishy to me...
When I was in the biological research field, the FDA trials were fully taxpayer-funded. This meant that the decision to approve a drug or vaccine was not directly influenced by funding from the pharmaceutical companies who were asking to have their products decisioned, and also meant that, with somewhat limited funds, the FDA had to prioritize what was most important. In my opinion, we should go back to that funding model. From an article from the University of Connecticut:
“In 1992, in response to intense pressure, Congress passed the Prescription Drug User Fee Act. It was signed into law by President George H.W. Bush. With the act, the FDA moved from a fully taxpayer-funded entity to one funded through tax dollars and new prescription drug user fees.”
I think you have misunderstood. He isn't saying the payers should do the trial--he is saying they should pay for the drugs prescribed without step edits or PAs. I don't understand why the pharma companies aren't providing the meds for free.
What I think would be helpful is if investigator-initiated trials could get drugs approved -- because often, the hurdle to these trials is getting drugs paid for. This would seem to me to make head-to-head trials easier--something no pharma co wants to do.
The answer seems obvious. The burden of providing evidence should be placed on those who will stand to gain the most from the intervention. If it’s an unproven procedure, then disallow the procedure until it’s been proven to be effective. This should motivate the providers to cooperatively figure out a solution to the question of how they share the cost of RCTs.
If the intervention is a drug, then it’s clear who should be bearing the burden of the cost to run those. Of course they shouldn’t be the ones running them, but they should be funding them.
The FDA solution to who should fund RCTs of fast tracked drugs fails to address the root cause: pharmaceutical industry pushing to get their drugs, some for rare diseases, out with minimal data. Califf is in synch with the Biden Administration’s bandaid solution of problems like the tuition forgiveness plan rather than looking at why higher education is so expensive.
Califf is a tool, nothing more, as evidenced by his Pom Pom girl tweets that echo non evidence based pronouncements.
They've gone from a post-truth mentality (e.g., "What's good for your good isn't necessarily good for my gander") to a truth-irrelevance mentality ("I don't care what the truth is, THIS is the way I'm going to lead"). Seems fishy to me...
When I was in the biological research field, the FDA trials were fully taxpayer-funded. This meant that the decision to approve a drug or vaccine was not directly influenced by funding from the pharmaceutical companies who were asking to have their products decisioned, and also meant that, with somewhat limited funds, the FDA had to prioritize what was most important. In my opinion, we should go back to that funding model. From an article from the University of Connecticut:
“In 1992, in response to intense pressure, Congress passed the Prescription Drug User Fee Act. It was signed into law by President George H.W. Bush. With the act, the FDA moved from a fully taxpayer-funded entity to one funded through tax dollars and new prescription drug user fees.”
I think you have misunderstood. He isn't saying the payers should do the trial--he is saying they should pay for the drugs prescribed without step edits or PAs. I don't understand why the pharma companies aren't providing the meds for free.
What I think would be helpful is if investigator-initiated trials could get drugs approved -- because often, the hurdle to these trials is getting drugs paid for. This would seem to me to make head-to-head trials easier--something no pharma co wants to do.
The answer seems obvious. The burden of providing evidence should be placed on those who will stand to gain the most from the intervention. If it’s an unproven procedure, then disallow the procedure until it’s been proven to be effective. This should motivate the providers to cooperatively figure out a solution to the question of how they share the cost of RCTs.
If the intervention is a drug, then it’s clear who should be bearing the burden of the cost to run those. Of course they shouldn’t be the ones running them, but they should be funding them.