3 ms·

Point 1 effectively happens today, with larger and successful pharma firms basically waiting on startups to do the heavy lifting/absorb risk of product developm

Point 1 effectively happens today, with larger and successful pharma firms basically waiting on startups to do the heavy lifting/absorb risk of product development, then swooping in at a late phase to acquire the startup. Point 2 is outside the FDA's mandate. Other HHS agencies like the CDC and BARDA are a better fit and more or less already do this. Point 3: again, outside the FDA mandate, and the FDA doesn't 'choose' anything in this sense. It evaluates safety and efficacy. Public health benefit is a secondary factor, and one that doesn't necessarily get heavy weight (e.g. Achaogen getting plazomicin 'Fast Tracked' by the FDA didn't seem to do much in Achaogen's favor in the end, with the drug only getting approved for a less-profitable indication). Point 4: Again, agencies other than the FDA already do this and are a better fit. Point 5: This is practically already how the industry works, though the FDA isn't the one calling shots.

DougWebb 6y ago
If it wasn't obvious, I'm talking about changing the FDA's mandate to nationalize drug R&D, while contracting the work out to private entites. I would actually require those entities to operate as non-profits too, in order to receive FDA contracts. If other agencies are a better fit for various parts of this plan, I'd do some reorganizing to bring them into a single organization. Maybe that's called FDA, maybe not. It would definitely be doing the FDA's current role in drug approval.
- sithadmin 6y ago
  Putting the same agency in charge development and regulatory QA is a horrible idea. Way too many perverse incentives there.
  - DougWebb 6y ago
    Such as? Corrupt behavior of government employees is already illegal, so if your concern is that they'd approve R&D funding for a drug and development company they have a financial stake in, that wouldn't be allowed and would be dealt with, unless they can prove that the drug really should be developed and the company getting the contract and funding really is the best choice. Same goes for the manufacturing side, once the drug is approved. And for the approval process, what perverse incentives would be created that don't already exist, and are already being dealt with? Today, anyone at the FDA who approves a drug that they've got some way to benefit from is already breaking the law.
    - sithadmin 6y ago
      >what perverse incentives would be created that don't already exist If the FDA is both in the business of facilitating R&D, and regulatory QA for the products resulting from said R&D, you're creating an internal feedback loop that results in a couple predictable courses of action for the organization to appear successful: 1. The R&D program 'picks winners' and puts low-hanging fruit in the product pipeline that's highly certain to pass QA. FDA looks good due to high % of approvals for products it pushes to develop, but doesn't really reward innovation or high-risk + high-payoff projects. While this yields benefits, it doesn't address the issue of trying to get 'moonshot' type projects that result in significant leaps ahead funded. 2.) The R&D program (predictably) suffers from the same sort of high failure rate and safety issues that plague pharma in general; it's not a fault of the FDA per se, but because our collective knowledge regarding mechanisms of action is still rather basic. FDA proceeds to be attacked by Congress, the public, the media, etc. for 'wasting taxpayer dollars' on a low-yield program. FDA officials are thus incentivized to let their standards of quality and efficacy slide in order to protect the agency's image on the R&D side of the house.
      - DougWebb 6y ago
        The organization will "appear successful" if it brings useful drugs to market at a reasonable cost to patients. There would obviously need to be unbiased criteria for deciding what's useful and what isn't, and the decisions around both selecting criteria and applying them should be made by medical professionals, not bureaucrats or MBAs. Your second argument could be applied to every government program, which are attacked all the time, with the intent to get rid of them and eventually have no government programs at all. That's a separate problem that needs to be solved.

DougWebb 6y ago

If it wasn't obvious, I'm talking about changing the FDA's mandate to nationalize drug R&D, while contracting the work out to private entites. I would actually require those entities to operate as non-profits too, in order to receive FDA contracts. If other agencies are a better fit for various parts of this plan, I'd do some reorganizing to bring them into a single organization. Maybe that's called FDA, maybe not. It would definitely be doing the FDA's current role in drug approval.

sithadmin 6y ago
Putting the same agency in charge development and regulatory QA is a horrible idea. Way too many perverse incentives there.
- DougWebb 6y ago
  Such as? Corrupt behavior of government employees is already illegal, so if your concern is that they'd approve R&D funding for a drug and development company they have a financial stake in, that wouldn't be allowed and would be dealt with, unless they can prove that the drug really should be developed and the company getting the contract and funding really is the best choice. Same goes for the manufacturing side, once the drug is approved. And for the approval process, what perverse incentives would be created that don't already exist, and are already being dealt with? Today, anyone at the FDA who approves a drug that they've got some way to benefit from is already breaking the law.
  - sithadmin 6y ago
    >what perverse incentives would be created that don't already exist If the FDA is both in the business of facilitating R&D, and regulatory QA for the products resulting from said R&D, you're creating an internal feedback loop that results in a couple predictable courses of action for the organization to appear successful: 1. The R&D program 'picks winners' and puts low-hanging fruit in the product pipeline that's highly certain to pass QA. FDA looks good due to high % of approvals for products it pushes to develop, but doesn't really reward innovation or high-risk + high-payoff projects. While this yields benefits, it doesn't address the issue of trying to get 'moonshot' type projects that result in significant leaps ahead funded. 2.) The R&D program (predictably) suffers from the same sort of high failure rate and safety issues that plague pharma in general; it's not a fault of the FDA per se, but because our collective knowledge regarding mechanisms of action is still rather basic. FDA proceeds to be attacked by Congress, the public, the media, etc. for 'wasting taxpayer dollars' on a low-yield program. FDA officials are thus incentivized to let their standards of quality and efficacy slide in order to protect the agency's image on the R&D side of the house.
    - DougWebb 6y ago
      The organization will "appear successful" if it brings useful drugs to market at a reasonable cost to patients. There would obviously need to be unbiased criteria for deciding what's useful and what isn't, and the decisions around both selecting criteria and applying them should be made by medical professionals, not bureaucrats or MBAs. Your second argument could be applied to every government program, which are attacked all the time, with the intent to get rid of them and eventually have no government programs at all. That's a separate problem that needs to be solved.