This occurs because reviewers conduct the review in a way designed to permit the agency to deny any request for an evidentiary hearing, as opposed to conducting the review to the point where the agency is comfortable that the safety of the additive has been demonstrated. Until Congress acts to eliminate the opportunity for a formal evidentiary hearing, FDA should continue current efforts to expedite preparation of the preambles that accompany regulations to authorize the use of additives. Lengthy delays in the documentation of the agency's conclusion that an additive is safe bring no benefit to public health and occur at the expense of the petitioner and the public. Finally, FDA should support revisions to the act that would permit it to consult with experts outside the Federal government on scientific issues that arise in the course of petition review without the need to resort to the cumbersome procedures of the Federal Advisory Committee Act. It is obvious that no amount of additional resources will permit FDA to hire sufficient personnel to always have available to it the scientific or technical expertise needed to address the complex and novel issues that increasingly arise in petition review.
Current law constrains the ability of the agency to obtain outside technical advice.
A simple change to current law would facilitate the ability of the agency to obtain input from academic experts when needed. The review process should be made more efficient and transparent by developing a management plan for each petition, updating FDA guidance documents on the preparation and filing of petitions and supporting documentation, and establishing routine communication between reviewers and petitioners. Even without statutory amendments or budget increases, we believe FDA can do a great deal to make the review process more efficient and transparent. First, FDA should develop a management plan for the review of each petition filed. The management plan is essentially the plan of action through which FDA will conduct and complete the review of a petition.