Pharmaceutical industry letter on data access

Junkman's comments in [bold brackets]


May 18, 1999

The Honorable James Walsh
2351 Rayburn House Office Building Washington, DC 20515

The Honorable David Price 2162 Rayburn House Office Building Washington DC 20515

Dear Representative Walsh and Price:

We are writing in support of the amendment you will be offering during the Appropriations Committee consideration of the FY 2000 Treasury, postal Service and General Government Appropriations bill. The Walsh-Price Amendment would impose a one-year delay on implementation of the revision of Circular A-100 mandated in the Omnibus Appropriations Act (Public Law 105-277).

The pending revision of Circular A-110 requires that data from all federally-funded research be subject to the Freedom of Information Act. [False. The pending revision only applies to data used to support federal policy, not all data from federally funded research. Click here for the OMB-proposed revision.] This requirement could result in the dissemination and publication of early research observations, raw clinical trial data, and other proprietary information arising from collaborative research agreement between the companies we represent and NIH-supported laboratories. [False. Studies used by federal agencies to support regulation are generally in the published scientific literature. Federal agencies do not use "early research observations, raw clinical trial data, and other proprietary information" to justify regulation.] Such dissemination and publication could be misused or misinterpreted by consumer and other non-expert organizations, compromise patient confidentiality, and undermine the patentability of inventions. [False. This can't happen because these data are not subject to the pending revision of Circular A-110.]

It would be a serious mistake to undermine the partnerships between NIH and its grantees and the biotechnology industry. These partnerships make the United States preeminent in biomedical research internationally -- and fuel billions of dollars in economic development. We believe the FOIA revision as proposed could undermine this relationship and should be put on hold for one year so that the National Academy of Public Administration can study the issue and make appropriate recommendations to Congress. [False. The FOIA revision has no relationship to the partnerships between NIH, its grantees and the biotechnology industry.]

Thank you for your leadership on this critical research issue. Sincerely,

33 Chairmen/CEOs of pharmaceutical companies (names and companies omitted)


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