Statement of Jim Tozzi

Member, Board of Advisors, the Center for Regulatory Effectiveness


Before The FDA Arthritis Advisory Committee and the

Drug Safety and Risk Management Committee


February 17, 2005



Distinguished members of the Committee:


I am Jim Tozzi, member of the Board of Advisors of the Center for Regulatory Effectiveness.


The Center receives no funding from the pharmaceutical industry although a number of years ago we did receive grants from the industry.


The Center for Regulatory Effectiveness is a regulatory watchdog funded by trade associations and private firms. The Center’s focus is to ensure that “good government” statutes, which regulate the regulators, are adhered to by federal regulatory agencies. To this end, we have a particular interest in FDA compliance with the requirements of the Data Quality Act when the agency makes determinations regarding the benefits and risks associated with the use of Non-Steroidal Anti-Inflammatory Drugs.


Requirements of the Data Quality Act (DQA)


The DQA directed OMB to promulgate guidelines which would “ensure and maximize the quality, objectivity, utility and integrity of information disseminated by Federal agencies.”


Pursuant to this Congressional directive OMB issued guidelines which each agency was to use as a basis for crafting its own data quality guidelines.


Pursuant to the OMB guidelines, FDA issued a twenty page document which describes the principles govern the release of information to the public.


The OMB data quality requirements include:


“The guidelines call for the agency to determine that “influential” analytical results be capable of being substantially reproducible by individual analysis.”



DQA Impact On Advisory Committees


Consequently, the passage of DQA placed new responsibilities on agencies.


The question I would like to address is the impact of the DQA on Advisory Committees.


To set the record straight, the DQA places absolutely no requirements on advisory committees. Advisory committees are free to offer any views they wish.


However, the FDA cannot use the findings of an advisory committee unless its analyses meet the requirements of the DQA.


Furthermore, any third party could move to have the agency not adopt the views of an advisory committee if it demonstrates that the views of the advisory committee do not meet the requirements of the DQA.


The FDA data quality guidelines state:


“If we rely on information submitted to us by third parties in support of an application for product approval or in a rulemaking proceeding, we make sure that this information meets the appropriate standards for quality and objectivity.”


Advisory committees are third parties under the Data Quality Act.


Where does this leave us? Basically, advisory opinions not based upon a demonstrable scientific record may not survive as admissible advice to a regulatory agency.


Consult the CRE website for additional details at: