I know very little about this, but could someone give a good explanation on how is a drug officially approved for mass use when the manufacturer of the drug still hasn't finished their testing?
Nitpicking: The FDA doesn't test every single batch of each product. They review the results of the clinical trials and then they set the rules to approve the batches. When a batch is ready, someone in the drug production factory is responsible to check that all the test and quality meet the regulations and then sign a paper approving the release. S/he must have a degree in pharmacology or chemistry or something similar. If something gets wrong the person that signed the release approval is the first one that get questioned, so they should be very careful.
It's somewhat similar to the role of the NHTSA(?). They set the general rules and approve each vehicle model, but they don't go to the factory to test each single car.
Before people get excited that the FDA approved something, how much testing have the FDA done on this product and how many other tests have they declined to authorize?
Right now, FDA approved means about as much as Probably not immediately lethal.
any drug that is sold in US needs to have its factory inspected by FDA. May be they should not approve them in the first place if there is any concern.
Based on a podcast I heard this week FDA approval also looks at quality assurance of mass manufacturing, storage, supply chains, etc. It’s not just about efficacy and safety of the formulation, itself, but whether they can be assured at scale. It takes time to check all those boxes.
If they get an FDA approval, it would mean that there has been review that their outputs are actually appropriate. That's why the FDA is required by law to review items marketed for diagnosing disease.
It's really a form of regulatory capture and goes way beyond drugs into medical devices, IT systems, etc. The "approved" thing is often a more expensive, less complete/reliable/modern version of something people who aren't subject to regulation can get off the shelf. You can think of it sort of like if car dealerships managed to get a law passed that said you can only service your car at the dealership, and then 10x'd their prices.
The FDA has a number of ways of getting around this for drugs that have limited effect. This is for drugs to be used in the general population, drugs for major illnesses.
The FDA approves things based on the purpose they were presented to the FDA/market for.
It isn't based on danger, it is based on evidence backed disclosure of the danger.
In the specific use the company told the FDA about, it passed, and that will usually happen with some objections or outright denial. The denial didn't happen and that isn't article worthy.
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