Statement Before FDA Advisory Committee On Bextra, Celebrex & Vioxx Side Effects

MR. TOZZI: Thank you, Mr. Chairman, Distinguished members of the Committee. Having been a resident of New Orleans, I cannot speak that fast, and I have burned up 10 minutes or 10 seconds

I am Jim Tozzi. I am the 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 is a regulatory watchdog. To this end, we have a particular interest in the FDA compliance with the requirements of the recently passed Data Quality Act. When the agency makes determinations regarding the benefits and risks associated with the use of non-steroidal

anti-inflationary drugs--sorry, I am an economist--anti-inflammatory drugs. They may be anti-inflationary, too.

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.

So, you may be asking why am I here. Well, the 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 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.