Over the past couple of months, the press has been full of articles on the threats against patents by Thailand, Brazil, and other third world nations.

But it is also full of articles on other pharma themes, mostly involving a sclerotic U.S. FDA. To wit:

(1) The FDA's recent refusal to approve two promising cancer drugs that came close, but did not quite meet, the statistical standards of efficacy, even though there are no alternative treatments, the drugs have no side effects, and the expert advisory committees strongly favored approval;

(2) The FDA's assertion of authority to refuse to approve a drug that it regarded as a "me too" drug, one that duplicated the benefits of an existing one, even though, one might think, competition should be regarded as a good thing;

(3) The FDA's penchant for pulling drugs off the market at the least threat of possible adverse effects, even if suffering patients do not have good alternatives and are willing to run the risks involved.

One would think that Thailand, Brazil, etc., would regard this situation as an opportunity. Increase, rather than decrease, IP protection, install a 21st century regulatory system instead of a 20th (if not 19th) century model, and watch the companies and the patients beat a path to your door, on the theory that what works in SE Asia cannot long be withheld from U.S. consumers.

Southeast Asia is already becoming known for "medical tourism," in the context of surgery. Why not pharmaceuticals as well?

(For lots of material, see WSJ.com, passim, but a subscription is required.)

posted by James DeLong @ 8:46 AM | Pharma

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