U.S. may speed approval of 'breakthrough' drugs. Or may not... (see debates also here). Let's see what is declared:
Experimental drugs that show a big effect early in development for treating serious or life-threatening diseases would get a faster and cheaper path to U.S. approval, under a proposal likely to become law this year.
U.S. drug regulators would be able to label such treatments "breakthrough" therapies, and work with companies to speed up clinical trials, for example by testing the drugs for a shorter time or enrolling fewer patients.
The plan fits with President Barack Obama's aim to foster innovation as a means of spurring job creation, and may pacify some critics who say the FDA lags European countries in approving new medicines or medical devices.
Well, I have a couple questions: the magic word “innovation” - who will provide the innovations? Big Pharma? I am serious, so far Big Pharma provided us with almost only me-too products inclusively biosimilars which are also me-too drugs. And are there any possible beneficiaries besides Big Pharma out there of the proposed changes? The answer is “No”.
I am afraid that this proposal will help Big Pharma to register their inefficient and more expensive (for sure!) drug candidates. The algorithm is simple: a Big Pharma company Schshmizer or Schmerk has a product XYZ and the company claims that the product is innovative (who can compare which product is more innovative?) and against serious disease (the majority diseases can be claimed as serious), gets this accelerated status and... the same situation as with Avastin... Well, I would like to be wrong but it looks like I am 200% right... Please, can you leave the old system unchanged?
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