3 ms·
An idea that I've had, for an approach to reduce the cost of drug development, would be to give the FDA the job and resources of carrying out the entire clinica
by DougWebb 9y ago
An idea that I've had, for an approach to reduce the cost of drug development, would be to give the FDA the job and resources of carrying out the entire clinical trial process. They would be responsible for choosing which drugs to trial, running the trials, evaluating the results, and publishing the results. The pharmas would do the basic research, but they'd have to come up with a convincing argument that their new drug was worthwhile before the clinical trials could start.
I'd hope that this would reduce costs because it eliminates all of the oversight that the FDA needs to do now to make sure the trials are being run properly, and that bad results aren't being hidden from view. It lets the FDA scientists control the whole process, and it would let the FDA short-circuit the process in cases where the scientists are satisfied by their counterparts in other countries approval of a drug. By giving adequate funding to the FDA, this approach would also allow the FDA to run trials on non-patentable drugs, nutrients, and remedies, which rarely happens today and could lead to much lower-cost treatments overall.
The other big aspect of this idea is that the FDA publishes results. I'd have them publish a journal for medical professionals which includes notices of new drugs being considered for trials, the current trial schedule, reports on on-going trials, overviews of completed trials, and announcements for drugs that have been approved that includes usage guidelines for doctors. I'd also have them maintain a website targeted towards patients that includes handouts and detailed information for patients, similar to what's on Wikipedia, drugs.com, webmd, etc, but all centralized, searchable, and from a well-trusted official source. If the FDA takes care of all of that, then we can ban drug advertising. Doctors won't need it because they'd get the journal (which would be free), and patients don't need it because they'd have the website. So that eliminates a huge cost that the pharmas are incurring, and will no longer need to recover from sales.
I don't know how feasible this is; I'm not an insider in the system. It would be a major shift in policy and a major budget increase for the FDA, so politically it'd be very difficult to accomplish. But if the end goal can work, then the political fight would be worth it.