Unfortunately, as far as I am aware, generic fast tracking does not exist. (That doesn't mean that the FDA can't update its procedures.). "Unmet medical need" has a specific definition and that generally does not include questions of access.
Fast-tracking generics would infringe on the current intellectual property rules of 7 years of exclusivity, which is a key part of the economic math that drives the biotech industry. Changes to the IP regime could undermine a great deal of future therapies.
Pricing negotiation and bulk purchases are the way to go until Ozempic comes off patent, which is not that far away in the long run, and with so much non-generic competition coming down the line as well, plus all of the compounding pharmacy work that is still going on.
Accelerating access by 3-4 years does not seem worth such a major disruption the medical innovation pipeline as changing the IP rules.
I largely agree with the thrust of what you're saying, but there a number of things you can do around the margins here that can help. For example, you can expand Bolar exemptions and you can limit data exclusivity. But I agree that you don't want to go too far and undermine the IP regime and the incentive to innovate. That's why I didn't advocate for like march-in on patents compulsory licenses are anything like that. You want this to be something the companies are ok with so there's a fine line you want to walk on accelerating access without undermining incentives to innovate.
I understand why workplace based health insurance doesn’t pay for stuff that only benefits in the long term because people change plans all the time, but I don’t understand it for state insurance like Medicare, Medicaid, or state employee health insurance because in general you’ll have the same plan for years and years
Unfortunately, as far as I am aware, generic fast tracking does not exist. (That doesn't mean that the FDA can't update its procedures.). "Unmet medical need" has a specific definition and that generally does not include questions of access.
Fast-tracking generics would infringe on the current intellectual property rules of 7 years of exclusivity, which is a key part of the economic math that drives the biotech industry. Changes to the IP regime could undermine a great deal of future therapies.
Pricing negotiation and bulk purchases are the way to go until Ozempic comes off patent, which is not that far away in the long run, and with so much non-generic competition coming down the line as well, plus all of the compounding pharmacy work that is still going on.
Accelerating access by 3-4 years does not seem worth such a major disruption the medical innovation pipeline as changing the IP rules.
I largely agree with the thrust of what you're saying, but there a number of things you can do around the margins here that can help. For example, you can expand Bolar exemptions and you can limit data exclusivity. But I agree that you don't want to go too far and undermine the IP regime and the incentive to innovate. That's why I didn't advocate for like march-in on patents compulsory licenses are anything like that. You want this to be something the companies are ok with so there's a fine line you want to walk on accelerating access without undermining incentives to innovate.
Ha you think we live in a functional country lmao
I understand why workplace based health insurance doesn’t pay for stuff that only benefits in the long term because people change plans all the time, but I don’t understand it for state insurance like Medicare, Medicaid, or state employee health insurance because in general you’ll have the same plan for years and years
I am not sure about the Medicaid buy in.
Are these only people that don't have health insurance?
Or is it anyone?
You can't gut the normal market