Something a bit similar is clinical trial and it is accepted without problem.
You make a black box test on several thousands (sometimes only hundreds) patients, and if patients who received the drug perform better the patients who received the placebo, then the drug is usually accepted for commercialization.
Yet one isolated patient may be subject to several comorbidities, her environment could be weird, she could ingest other drugs (or coffee, OTC vitamins or even pomelo) without having declared it. In a recent past women were not part of clinical trials because being pregnant makes them very "non-standard'.
> Something a bit similar is clinical trial and it is accepted without problem.
Clinical trials also have strict ethical oversight and are opt-in. If clinical trials were like Teslas, we'd yeet drugs into mailboxes and see what happened.
First of all, clinical trials are typically longer and more thorough than you imagine, they span years. The fact that COVID vaccines were fast-tracked gives people wrong idea about it.
Secondly, even after the product hits the market the company is still responsible for tracking any possible adverse effects. They have a hotline where a patient or doctor can report it, and every single employee or contractor (including receptionists, cleaning staff, etc.) is taught to report such events through proper internal channels if they accidentaly learn about them.
You make a black box test on several thousands (sometimes only hundreds) patients, and if patients who received the drug perform better the patients who received the placebo, then the drug is usually accepted for commercialization.
Yet one isolated patient may be subject to several comorbidities, her environment could be weird, she could ingest other drugs (or coffee, OTC vitamins or even pomelo) without having declared it. In a recent past women were not part of clinical trials because being pregnant makes them very "non-standard'.