It can change regulations around longevity drugs in both directions. If the product gets brought by people and found ineffective, people will complain that the FDA was not stringent enough and the FDA has the motivation to be more stringent.
Are there examples of ineffective drugs leading to increased FDA stringency? I’m not as familiar with the history. For example, people agree that Aducanumab is ineffective, has that cause people to call for greater scrutiny? (genuinely asking, I haven’t followed this story much).
There are definitely examples of a drug being harmful that caused increased scrutiny. But unless we get new information that this drug is unsafe, that doesn’t seem to be the case here.
The report included three recommendations that it believed FDA should immediately implement, including:
Keeping proper documentation of the agency’s interactions with drug companies
Creating clear protocols for when the agency can create joint presentations with companies
Updating its guidance for the development of new Alzheimer’s drugs
So the FDA was tasked to do more bureaucracy.
When it comes to this drug, the drug is approved as an animal drug which at the moment does not require clinical trials to be approved. If there’s a case of a lot of animal owners being dissatisfied with the FDA for allowing ineffective animal drugs, that does support a call to regulate animal drugs more like human drugs that require clinical trials to be marketed.
It can change regulations around longevity drugs in both directions. If the product gets brought by people and found ineffective, people will complain that the FDA was not stringent enough and the FDA has the motivation to be more stringent.
Are there examples of ineffective drugs leading to increased FDA stringency? I’m not as familiar with the history. For example, people agree that Aducanumab is ineffective, has that cause people to call for greater scrutiny? (genuinely asking, I haven’t followed this story much).
There are definitely examples of a drug being harmful that caused increased scrutiny. But unless we get new information that this drug is unsafe, that doesn’t seem to be the case here.
There was a congressional inquiry that then tasked the FDA to:
So the FDA was tasked to do more bureaucracy.
When it comes to this drug, the drug is approved as an animal drug which at the moment does not require clinical trials to be approved. If there’s a case of a lot of animal owners being dissatisfied with the FDA for allowing ineffective animal drugs, that does support a call to regulate animal drugs more like human drugs that require clinical trials to be marketed.