Member, Board of Advisors, the Center for Regulatory
Before The FDA Arthritis Advisory Committee and the
Drug Safety and Risk Management Committee
February 17, 2005
members of the Committee:
am Jim Tozzi, member of the Board of Advisors of the Center for Regulatory
Center receives no funding from the pharmaceutical industry although a number
of years ago we did receive grants from the industry.
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 directed OMB to promulgate guidelines which would “ensure and maximize the
quality, objectivity, utility and integrity of information disseminated by
to this Congressional directive OMB issued guidelines which each agency was to
use as a basis for crafting its own data quality guidelines.
to the OMB guidelines, FDA issued a twenty page document which describes the
principles govern the release of information to the public.
OMB data quality requirements include:
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
the passage of DQA placed new responsibilities on agencies.
question I would like to address is the impact of the DQA on Advisory
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.
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.
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
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: http://www.thecre.com/quality/index.html