3 ms·

Thanks for the clarification (and no thanks for the utterly bizarre downvote, whoever that was - wtf?). Based on your experience, is it the companies themselve

by sambe 14y ago

Thanks for the clarification (and no thanks for the utterly bizarre downvote, whoever that was - wtf?). Based on your experience, is it the companies themselves who can get these later costs down, or is it entirely dependent on outside parties (regulators - only reduceable by lobbying)? In the context of the patent debate, it would make more sense for government to grant monopolies/patents where its own policies introduce the costs. Even if these costs do not decrease, because of e.g. public safety, this may actually be quite a nice criterion for things that should get protection.

refurb 14y ago
Right now what is happening is that companies are shifting their R&D efforts towards diseases that have relatively low regulatory barriers. The best example is the shift out of diseases like diabetes (treatments are relatively effective, so safety standards are very high) into diseases like cancer (where treatment options are poor and safety standards are relatively low because patients die so quickly). In the future I think it will be a combination of new technologies that allow drug makers to prove efficacy and safety in a more cost effective way. I also think regulators will soften their hard-line stance on safety (in some areas). The FDA has already started to do this. Instead of saying "that drug isn't proven safe" they are saying "that drug has been proven safe, but it helps a lot so maybe we'll allow the drug company to sell it to a few patients until we get more data". The current drug patent system isn't the best way to incentivise R&D investment, but all the other options out there seem worse right now. You are correct, however, in saying that the costs associated with drug approval are often external to the company (the FDA). So when you pay $300/month for a new drug, a lot of what you're paying for is an assurance of efficacy and safety (and the gov't agency that assures it's done right).

by sambe 14y ago

refurb 14y ago

Right now what is happening is that companies are shifting their R&D efforts towards diseases that have relatively low regulatory barriers. The best example is the shift out of diseases like diabetes (treatments are relatively effective, so safety standards are very high) into diseases like cancer (where treatment options are poor and safety standards are relatively low because patients die so quickly). In the future I think it will be a combination of new technologies that allow drug makers to prove efficacy and safety in a more cost effective way. I also think regulators will soften their hard-line stance on safety (in some areas). The FDA has already started to do this. Instead of saying "that drug isn't proven safe" they are saying "that drug has been proven safe, but it helps a lot so maybe we'll allow the drug company to sell it to a few patients until we get more data". The current drug patent system isn't the best way to incentivise R&D investment, but all the other options out there seem worse right now. You are correct, however, in saying that the costs associated with drug approval are often external to the company (the FDA). So when you pay $300/month for a new drug, a lot of what you're paying for is an assurance of efficacy and safety (and the gov't agency that assures it's done right).