Had a chat with a pharmaceutical company whistleblower recently.
They told me that FDA has nothing to do with actual product testing, e.g., human trials. What the "approval" guarantees is proper facilities and other second-order criteria.
I'm writing this comment in the hopes of learning that I have misunderstood something crucial here. Because if it is indeed the case that the companies themselves are the only ones vouching for drug safety, that old story about capitalism and incentives implies we're seriously fucked.
FDA clearance only means a company can legally market the device.
additionally, product testing != human trials. they are two very different things.
final product testing is called "design verification and validation" (aka dV+V) where a statistically significant number of devices are tested against several different categories.
human trials can run the gauntlet from a small IDE studies to phase I through IV.
the drug approval process is MUCH different than the medical device process.
They told me that FDA has nothing to do with actual product testing, e.g., human trials. What the "approval" guarantees is proper facilities and other second-order criteria.
I'm writing this comment in the hopes of learning that I have misunderstood something crucial here. Because if it is indeed the case that the companies themselves are the only ones vouching for drug safety, that old story about capitalism and incentives implies we're seriously fucked.