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FACA FACTS ARCHIVE

Tozzi Tells FDA That Agency Cannot Use FACA Reports Unless They Meet IQA Standards
Jim Tozzi is a member of the Board of Advisors for the Center for Regulatory Effectiveness. Mr. Tozzi recently made a statement to the FDA FACA committee on Bextra, Celebrex and Vioxx side effects.

In his statement, Mr. Tozzi explained that the Information Quality Act imposes no restrictions on reports by FACA committees. The committees can disseminate any information they deem appropriate without regard to IQA standards.

However, neither the FDA nor any other federal agency can rely on, use or endorse a FACA committee report unless the report meets IQA standards.

Mr. Tozzi also explained that federal agency use of FACA committee reports is subject to the IQA Request for Correction process. Under the RfC process, a member of the public or other third party can request necessary and appropriate changes in any federal agency information dissemination that relies on FACA reports which do not meet IQA standards.

The relevant portion of Mr. Tozzi's statement follows:

    "The Data Quality Act required OMB and FDA to issue guidelines which would maximize the quality, the objectivity, the integrity, and the information FDA disseminates to the public....[T]he guidelines require certain analytical results to be reproductive and unbiased--reproducible and unbiased. The Data Quality Act places no requirements on the distinguished members of this [FACA] committee, however, the FDA cannot rely upon the information it receives from the advisory committee unless the advisory committee information meets the requirements of the Data Quality Act.

    "Furthermore, any third party, such as CRE, can petition under this act for FDA not to use the results if they do not comply with the Data Quality Act"
  • Click here for Tozzi testimony



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