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I they seem to be explicitly targeting generics, so R&D doesn't come into play. It's really just find someone who can build a known compound and press it into a
by Clubber 9y ago
I they seem to be explicitly targeting generics, so R&D doesn't come into play. It's really just find someone who can build a known compound and press it into a pill. This has the potential to be massively disruptive.
- mirimir 9y agoEven generics need FDA approval. Manufacturers must demonstrate therapeutic equivalence.
- akozak 9y agoThat's interesting - even if they can prove chemically they're producing something that's already been approved?
- toomuchtodo 9y agoThat is part of the approval process. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm506040.htm https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUs...
- mirimir 9y agoYes. Bioavailability and absorption kinetics are major factors.
- usefulcat 9y agoAnd in order to get that approval, you will likely need a sample of the product that you intend to demonstrate equivalence to. Good luck getting that sample from the maker of the incumbent product who has nothing to gain and much to lose if your product were to get approved.
- refurb 9y agoNot being able to get a sample to prove bioequivalence is typically very easy. There are a handful of drugs that have a REMS program whereby the manufacturer is required to restrict access. We're talking maybe a few tens of drugs. And yes, drug companies playing the game of "I'm not allowed to give you a sample" is super shady and ridiculous. Wouldn't surprise me if this gets fixed super fast.
- AstralStorm 9y agoFDA could give overriding authority to oblige manufacturers to provide a sample to the generic manufacturers for drugs older than <x>. Of course this is bad for business. Alternatively the generic manufacturer would have to run a phase 1 and 2 trial. (Skip requirement for phase 3) Expensive, but much less than full R&D.
- refurb 9y agoMy understanding is that's the plan. Right now branded drug companies say "REMS regulations mean we can't provide a drug for anyone but a patient." All the gov't has to do is say "no, if a generic company requests a sample you can provide de it without violating REMS regulations".
- phillc73 9y agoThere is still a significant R&D element in that "press it into a pill" step. This is manufacturing and process R&D. For example, continuous (rather than batch) manufacturing is the big hotness at the moment. Also new techniques, such as 3D printed pharmaceuticals, involve plenty of R&D effort.
- Clubber 9y agoYes, but compared to R&D for creating a new drug, it's a fraction of the cost. Also, I would think to save costs, they would do it the cheapest way that is proven and reliable.