Drug Approval Denationalization

This seems like a bad idea.

0.) Thalidomide. (Approved in Europe, not the US, thank God.) At first, I assumed his proposal was to go the other way: States approve drugs individually, so that they can be tested on a medium scale before national deployment. That would make more sense to me.

1.) He too quickly dismisses the idea of a race to the bottom. Sure, Canada isn't going to deliberately approve dangerous drugs now, but with a financial motive at stake, it's only a matter of time until one country lowers its standards. Indeed, lowering standards is the whole point of the project!

2.) If you want lower standards, why not argue for them directly instead of calling for an international framework? If it can be argued for on the merits, you can do so here, not in Sweden or whatever.

3.) Are people in different countries alike? For example, the Japanese have a lot more fish in their diet, are more likely to be lactose intolerant, etc. Different countries different ethnic compositions could lead to different effects by some drugs.

4.) This is putting the onus of competition in the wrong spot. We shouldn't think of regulatory agencies as competing for the business of drug companies or vice-versa. We should think of both as competing for approval from consumers (doctors and patients). It would be better to create mechanisms to make the FDA respond to consumer demand than mechanisms to make it respond to drug makers' demands.

5.) This ignores many of the current problems with the system, such as how negative study results are never published (which creates a distorted picture of their effectiveness) and how misleading information is fed (almost literally, at fancy drug rep sponsored dinners) to doctors to make new (on patent) drugs look more effective than older off patent drugs, whether this is the case or not.

What I propose is that we could sign a treaty with other countries to do reciprocal drug recognition, but only if those other countries meet the minimum standards for testing. The minimum standard should be that a series of independently tests are commissioned by the regulatory agency and conducted by neutral outside groups (such as research universities and hospitals) and *their results must be published as a matter of public record no matter what the outcome*. This is an important requirement, since currently internal drug test by drug makers are trade secrets, which a) leads to duplicated efforts and b) allows bad results to be hidden from doctors.

There is some precedent for this idea. While in the US the FDA handles approvals for new drugs and new medical devices, in Europe there are separate processes for devices and drugs. For devices, a manufacturer must obtain the "CE" mark from any of a number of notified bodies, which are authorized by the individual member states of the EU to certify devices. As such, manufacturers can choose between a number of notified bodies to review their submission (here is a list of notified bodies in Europe). This page explains the process from a higher level.

It is very common for medical device manufacturers to seek (and win) product approval in Europe before the US. Typically, the chronological order of approval is Europe->US->Japan.

(I work at a medical device company, but not in the Regulatory department.)

Emma Zahn, I do not remember hearing Dan mention China. He mentioned a list of industrialized nations.

Unfortunately, I cannot form a firm opinion on this, because I don't know much about the mechanics that govern the drug market or drug research and development, which would be key to crafting good policy. However, it does seem to me that such an agreement would require a new set of agreements between the countries involved to ensure that each national FDA met certain standards, so I'm not sure that this would be such a simple step as Dan suggests, though I suspect that it is quite doable.

So if China approves a prescription toothpaste or baby formula, it would be automatically approved here? I'll pass. It also seems problematic for manufacturers to be able to shop for approvai with the friendliest jurisdiction.

I much prefer that the FDA not 'approve or disapprove" any drugs or restrict them. They should provide enough information so that we can make our own informed decisions, Additionally, it would be more beneficial to the public if they provided oversight of manufacturing as they do with food, especially meat, processing to assure product safety.