May 29, 2012

More on the FDA

One of the posts I did at the Monthly was on the FDA's approval process. Rand Paul got a proposal passed saying the FDA must accept science done in the EU and elsewhere in the developed world into their approval process, with the idea of speeding things along. Alex Tabarrok proposed that any drug or treatment approved in the industrialized world (meaning Canada, the EU, Japan, Australia, New Zealand, and South Korea) would receive automatic approval here in the US in 90 days, and I somewhat hastily agreed.

The background here is that the FDA is notoriously slow about new drug and treatment approval; personally I'd like to see the artificial pancreas delivered as fast as possible for my father, who despite being a generally healthy, slim guy, developed type I diabetes a couple years back.

Commenters on the post brought up thalidomide, which is surely worth considering. Briefly, that was a drug used for a short time in Britain, Australia, and elsewhere used to treat morning sickness. Turns out, it causes horrible birth defects, and the US mostly dodged a bullet when the FDA administrator of the day refused to approve it, saying more studies were needed.

But that was a long time ago, and before the modern rules were implemented. These days the big problem is pharma lobby capture of the approval process. These days, what is needed to demonstrate efficacy of a new drug is two positive-result studies. The drug companies can sponsor as many studies as they like, and don't have to reveal any they don't like (i.e., negative results), as they're considered proprietary and therefore confidential. That distorting influence is what leads to things like the Vioxx .

On further thought, I think the commenters that disagreed with Tabarrok are right. That kind of automatic process would probably lead to the pharma lobby concentrating their power on the weakest regulators to get mechanical, rubber-stamp approval. However, I still think Paul's proposal is good. More studies from credible sources can seldom hurt, especially in the current environment. I would combine it with mandatory open-access rules for publicly-funded studies, and more journals dedicated to publishing negative results.

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