I'm surprised at the difficulty I have in convincing people that eliminating the FDA is a good idea. The FDA makes the build-compile-run cycle in medicine 10x longer and more expensive. That's a mighty brake on technological progress.

It's one thing to say that the FDA stands in the way of progress in medicine, however what regulatory framework would you suggest be put in its place to protect consumers if it was removed? I would argue that the break is not on technological progress, (I could scarcely imagine it possible that 10, or even 5 years of current progress could be achieved in 1, as you imply) - but in the practical application of these advances to patients. I believe that for the most part this is warranted, because despite the in Vivo or on paper promise of a technology, in the biological sciences it often takes about 10 iterations to make it safe and efficacious in Vivo, and this translatory delay allows this to happen. Not ideal, but IMHO better than an alternative that puts lives at risk.

I just don't see how we can circumvent RCTs as the burden of proof for efficacy and safety. Probably, yes, we could slash a lot of fat from the FDA, and trim a lot of processes... But do away with it entirely?

I would be interested to hear what your alternatives are

Two thoughts for your consideration.

1) Opt-out. Allow anyone to opt-out of the FDA. That is, allow terminal patients/early adopters/test pilots to voluntarily buy products from companies before the FDA certifies them as safe and effective. For example, people might decide that they will use drugs that have cleared Phase I trials and proven safe, and use their own judgment for whether the drug is effective. Essentially this is a rollback of cases like Cowan vs. United States, a 1998 case in which the FDA sued to prevent a terminal AIDS patient from using a drug that they had not yet approved:

http://goo.gl/li7jl

2) Multiple regulators. The purpose of sites like Metacritic or Rotten Tomatoes is that any one reviewer is flawed, but an aggregate will usually be better. But for most drugs and devices, only a very small number of people within the FDA plus perhaps a 15 person expert panel are involved. FDA does not have the internal expertise to evaluate all fields of medicine, so frequently gets outside experts from Harvard Medical School, the Mayo Clinic, and the like to serve on its panels. Here is an example where the chair is from Mayo:

http://goo.gl/8lxEQ

The multiple regulators concept would allow any of these institutions to certify drugs and devices, just as we allow multiple medical schools to certify MDs. As another analogy, a company rejected by one regulator can get a second opinion from another, just as academics can submit to multiple journals if the first one rejects a paper. Indeed, much FDA review is already subcontracted out to expert panels from these institutions anyway. In return for doing approvals, Harvard Med or Mayo would get the user fees authorized under PDUFA/MDUFA that would otherwise go to FDA. People could wait for a drug to be approved by the FDA, or they could take a drug which had Harvard Medical School's stamp of approval.

These two proposals - opt-out and multiple regulators - are relatively simple to implement yet will cause huge changes in the system.

Right now we have a crude version of both in that a wealthy patient can opt-out of the FDA by flying to Europe, and a company can to some extent have multiple regulators by going for the EU's CE Mark first rather than the FDA. Indeed, within the medical devices space they now say "Europe first" just like internet startups today say "mobile first".

But it would be better if a patient could opt-out without flying to another country, and a company could get a second opinion from a different regulator without launching outside the US.

That's interesting, thank-you for jumping in with a reply.

I don't disagree with pt 1, but feel that multiple regulators or regulatory aggregates can complicate the process and allow a lot of trash in... At the moment (and I must say I come from Australia so I don't fully understand the intricacies of the FDA, but we have a similar body here; and I am involved in Medicine so that is where this next bit of perspective comes from) having a single body in charge of approved treatments also serves a role of keeping the trash out. By this, I mean alt-med and all the rest of it.

For example, what would stop a total charlatan from coming to market, using all the tricks of personality and promotion that alt-med treatments do today, but in the absence of a single body meant to represent society's best interests to say 'this is fraud', winning the favour of, for example, cancer patients, taking their hard earned, getting good reviews, and then the patients dying?

It's hard enough to stop this kind of thing from happening even now, but in the absence of a single regulator/presence of multiple agencies the scammers can slip through the cracks, their clients die so there aren't any bad reviews, and they build nice houses and piles of money.

I would also hate to be a Doctor in this environment; it is hard enough being a GP in this day and age with Dr Google suggesting treatments and diagnoses to patients and more and more patients presenting with reams of paper fresh from the internet insistent that they have some deadly tropical disease; Under this system we would have patients presenting with serious conditions insisting that they want this treatment over that one because they read a review online saying this or that.

Food for thought anyway. I agree that something needs to be done and think it is a bit of a minefield trying to work out how to strike the right balance of regulation whilst also reducing red tape

Government is an accretive process. Like evolution. What you want is a separate program, with some fast track process. :-)

depressing to see it all spelt out like that.