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You're right that the solution shouldn't be automatic US approval for any drug used in Russia. It's reasonable to have standards for drug testing and require th
by davmre 12y ago
You're right that the solution shouldn't be automatic US approval for any drug used in Russia. It's reasonable to have standards for drug testing and require that any drug used in the US is tested to those standards.
The problem isn't (only) that US drug standards are strict. The problem is that the financial burden of testing a new drug, which is significant, lies solely on the manufacturer, who can only recoup those costs by selling patented drugs at high prices. This means that the incentives don't line up for drugs not covered by US patents: because there's no profit in selling them, no manufacturer can justify funding the clinical trials to get them approved. This despite the fact that society would, as a whole, benefit from having those studies done.
One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on. You could also imagine a free-market variant, in which the government just auctions off US patent rights for foreign drugs; the auction winner gets exclusive rights to sell the drug in the US for some limited period of time in exchange for agreeing to fund FDA approval.
- leonth 12y ago> One obvious solution would be a government program whose mission is to identify promising treatments for which private incentives don't line up, and shepherd them through the approval process by funding clinical trials and so on You already have this. It's called Orphan Drugs in the US. http://en.wikipedia.org/wiki/Orphan_drug http://en.wikipedia.org/wiki/Orphan_drug > a free-market variant, in which the government just auctions off US patent rights for foreign drugs This will probably work. But once the barrier is too low, a lot of "useless" drugs will show up (i.e. providing more choices to prescribers but in reality does not really give much benefit) - and you need to fund those too using the taxpayers' money.
- davmre 12y agoCool, I wasn't familiar with the Orphan Drug program. From the Wiki page it looks like it's focused on development of new drugs for rare diseases, for which the market is inherently small and thus impossible to do large clinical trials, etc. That's similar to but not quite the same as the problem here, where a drug already exists and the market is potentially quite large, but the lack of patent protection prevents any one company from funding its approval. Do you know if the Orphan Drug Act specifically designates some government body with the mandate and funding to study and approve pre-existing foreign drugs? If not, maybe that could be a useful extension.
- leonth 12y agoI see, it is indeed quite different. I'm not sure what the Orphan Drug Act specifically says though. Actually if the market is potentially quite large, big pharmas should already be researching it. The problematic ones are those that are in-between orphan drug and market-quite-large drug. The society probably needs less of these drugs (there should be alternatives at the other ends), but if it's still needed, maybe expanding the scope of the Orphan Drug Act can be a good solution.
- Retric 12y agoYou can get a patent for 'novel' treatments for existing drugs which should in theory fix this issue.