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« The Uncertain Future of Genetic Diagnosis of Human Behavior | Main | Generic Pharmaceuticals Conference »

June 18, 2009


If Congress grants any data/market exclusivity for FOBs, we should explore full data disclosure for safety and efficacy, including the full package delivered to the FDA. Early disclosure of this information would allow public vetting of safety and efficacy data, with free riding prevented through marketing exclusivity.

On the issue of funded research, you identify the "Teva-funded white paper" but not Grabowski's funding. You describe AEI and Calfee as "nonpartisan" but there is no doubt that Calfee's work has been pro-PhRMA with significant industry support. Apply the same standard to everyone in the article.


With regard to funding, I identified Mr. Brill's white paper as being funded by Teva because the paper itself states so. In addition, Patent Docs provided a separate report on Mr. Brill's paper back in November when it came out (http://www.patentdocs.org/2008/11/white-paper-from-former-house-ways-and-means-economist-finds-7year-data-exclusivity-period-to-be-suf.html). You may be interested to know that Mr. Brill is himself an AEI Research Fellow (http://www.aei.org/scholar/123).

As for the AEI, I described that organization as a "nonpartisan public policy" group because that's how the AEI describes itself on its own website (http://www.aei.org/about). In addition, unlike Mr. Brill's paper, Mr. Calfee's paper does not indicate that it was supported by funding from an entity other than the AEI (if you have evidence to the contrary, we would be happy to report on it).

Finally, with respect to the Grabowski study, you are correct in pointing out that Prof. Grabowski's research was supported in part by a grant from the Pharmaceutical Research and Manufacturers of America (PhRMA) (as well as a grant from the Duke University Program in Pharmaceuticals and Health Economics). However, it should be noted that our reports on Mr. Calfee's and Mr. Brill's papers were about the substance and conclusions of those papers and not Prof. Grabowski's paper (i.e., our reports refer to Mr. Calfee's and Mr. Brill's comments about the Grabowski paper).

One other distinction between the three papers merits consideration: only Prof. Grabowski's paper was published in a peer-reviewed journal.


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