would be to assess whether redactions exceed what is necessary to protect confidential commercial information and trade secrets and critical aspects of FDA’s internal deliberations. A further step would be for FDA to explore with the National Library of Medicine how clinical and other reviews might be made accessible through PubMed and through links to trials registered at ClinicalTrials.gov. Such integration could provide an independent assessment to supplement sponsor summaries and publications. To obtain a better understanding of the dissemination of information, FDA could seek an assessment of private sector dissemination of findings from pediatric studies and labeling changes conducted under BPCA and PREA, including both the speed of dissemination and the accuracy and completeness of the information as disseminated.
The committee recognizes FDA’s limited resources. At the same time, it is concerned that rationales for ethically sensitive decisions be clear and also that the public have access to information in which sponsors, investigators, research participants, taxpayers and premium payers, and FDA staff have already invested—in different ways—considerable expense or effort.