#FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway | The BMJ
▻https://www.bmj.com/content/374/bmj.n1898
Théoriquement ces « #médicaments » doivent par la suite faire l’objet d’études visant à évaluer leur véritable efficacité. Aucun délai n’est imposé et certains ne sont retirés qu’après une décennie et plus (et des milliards de bénéfices engrangés).
Pearson told The BMJ, “I’m not shy in saying that some of [the suggested modifications] would just take the FDA a little bit closer to the way that the Europeans manage these things, where even the term conditional approval sends a different signal than accelerated approval.
“We could move the needle and get the true goal of accelerated approval, which is still a very viable one, [but] get it done in a way that really is more beneficial for patients in the long run.”