4.10: The committee recommends FDA establish a requirement that a substantial majority of the members of each advisory committee be free of significant financial involvement with companies whose interests may be affected by the committee’s deliberations.
The committee believes strongly in the importance of increasing the availability of information about risks and benefits, whether specific study results or CDER staff analyses of concerns, to the public and to researchers. The National Library of Medicine hosts a Web site for registration of clinical trials, but with few exceptions, this is voluntary. In 2002, pharmaceutical companies that are members of the Pharmaceutical Research and Manufacturers of America (PhRMA) committed to voluntary disclosure of the results of hypothesis-testing clinical trials for marketed and investigational drugs and in 2004 PhRMA launched a Web site (ClinicalStudyResults.org) for this purpose. A review of the site shows great variability in the ease of accessibility and completeness of the information.
4.11: To ensure that trial registration is mandatory, systematic, standardized, and complete, and that the registration site is able to accommodate the reporting of trial results, the committee recommends that Congress require industry sponsors to register in a timely manner at clinicaltrials.gov, at a minimum, all Phase 2 through 4 clinical trials, wherever they may have been conducted, if data from the trials are intended to be submitted to the FDA as part of an NDA, sNDA, or to fulfill a postmarket commitment. The committee further recommends that this requirement include the posting of a structured field summary of the efficacy and safety results of the studies.
4.12: The committee recommends that FDA post all NDA review packages on the agency’s Web site.
4:13: The committee recommends that the CDER review teams regularly and systematically analyze all postmarket study results and make public their assessment of the significance of the results with regard to the integration of risk and benefit information.
FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry. Although the agency historically has made effective use of its “bully pulpit” to compel sponsor compliance,