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Why Don’t We Have Drug Approval Reciprocity?

15 Comments

If the United States and, say, Great Britain had drug-approval reciprocity, then drugs approved in Britain would gain immediate approval in the United States, and drugs approved in the United States would gain immediate approval in Great Britain. Some countries such as Australia and New Zealand already take into account U.S. approvals when making their own approval decisions. The U.S. government should establish reciprocity with countries that have a proven record of approving safe drugs — including most west European countries, Canada, Japan, and Australia. Such an arrangement would reduce delay and eliminate duplication and wasted resources. By relieving itself of having to review drugs already approved in partner countries, the FDA could review and investigate NDAs more quickly and thoroughly.

Dan Klein and Alex Tabarrok here and more here.

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15 thoughts on “Why Don’t We Have Drug Approval Reciprocity?”

  1. “Why don’t we have drug approval reciprocity?”

    Employment probably. The more people we have approving drugs, the less unemployed. Heck, we should just have two jobs: drug developers and drug reviewers. Then, everyone will be employed!

    Sorry, for the tangent, but I can completely see Nancy Pelosi proposing this.

    2. I would imagine it’s more about control than employment. Reciprocity is a wonderful idea, but would suits then fall under the purview of the ICJ?

    3. I think it’s more about control than anything. What would happen to suits against big pharm, would they fall under the purview of the ICJ?

  3. Good question…but, perhaps they have different standards or we don’t view their scientists and standards up to par?

  4. Reciprocity means giving up some regulatory oversight. Giving up some regulatory oversight means reduced political power.

    It can be viewed, in part, as out-sourcing. As has been noted, the quality of other regulatory bodies, notably in Western Europe, is very high. It will increase efficiency and likely reduce costs, all with (likely) a net benefit of saving lives.

    It can allow the FDA to focus on the trickier drugs, and allow other countries to work on drugs that won’t have the external benefits that we could focus on (say, cancer drugs).

    But it’s a reduction of the Leviathan. And, for that reason, it’s simply not seen as an automatic thing.

    1. And I stated in my paragraph a lot of what Dr. Goodman already stated.

      *Facepalm.

  5. The FDA is far more meticulous than the European Commission is about drug safety. Most medical device manufactures (something like 75%) first seek approval abroad so they can be receiving an income stream before applying to the U.S. Food and Drug Administration. Of course, notice I didn’t say more bureaucratic and meticulous is necessarily better, just slower.

  6. I think an expiated process, like Australia and New Zealand, would be better than automatic approval.

  7. At the very least, I would think the U.S. should adopt some type of reciprocity system, where if a certain number of developed countries have approved a given drug, it receives conditional approval (i.e. permission to market) in the United States.

  8. I suspect that any effort to “outsource” U.S. drug approvals will bring up reminders of Thalidomide, and that it was approved in some 46 countries including Canada, but that FDA refused to grant its approval.

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