We have GCPs, GLPs, GMPs and others. We theoretically have GRRPs (Good Regulatory Review Practices)but the industry and public need to know that they are published and are being followed. How about an annual audit system conducted by GAO--and a comparable group in other countries?

Why is it that the systems for appealing the FDA's decisions and those of other regulatory agencies are so limited and fraught with repercussions? More oversight and accountability for the quality and rationality of their decisions is needed.

Ensure that at the end of every regulatory agency meeting the company summarizes all points of agreement and all action points for each side to conduct. If the agency makes this summary, ensure that it is complete and that all of their statements are acceptable.

Provide a copy of the company's minutes of every regulatory meeting to the agency within one week to assist them in preparing their own minutes, and to ensure that they have considered all of the points you have made.