The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
The Future of Drug Safety: Promoting and Protecting the Health of the Public
conflicts of interest developed by the Association of American Medical Colleges. All universities and nonprofit academic health care institutions should have standing conflict-of-interest review committees that are independent of their technology-transfer functions and are staffed by professionals who are experienced in managing conflicts of interest.
All stakeholders in the drug safety system have a legitimate interest in understanding the data on which drug availability in the marketplace depends. Not all people are interested in firsthand knowledge of the science and depend on the decisions of others (such as their physicians and regulator) to assure them that drugs they take are safe and effective. Others wish to have more knowledge of the data. Many data are made public in some form, at some time, and at some place on the FDA or another government or industry Web site, but the process is not systematic, comprehensive, or well organized. The committee believes strongly in the importance of increasing the availability to the public and to researchers of information about drug risks and benefits, whether specific study results or analyses of concerns by agency staff, and it provides several recommendations related to clinical trial registration and results reporting, Web-site posting of all NDA-review packages, and timely public release of all CDER summaries of emerging data relevant to the safety and effectiveness of a drug after approval.
As described in Chapters 2 and 3, information related to the efficacy of drugs approved for use in the United States is examined in extensive detail in the reviews prepared by CDER staff. Most of those review packages are posted on FDA’s Web site and summarize a significant amount of data supporting the approval of the drug, yet these postings do not include the entirety of what is known about a drug. A sponsor’s NDA is not made public (even in redacted form to protect proprietary interests), and FDA reviews of an NDA are not made public if approval is not granted. Those reviews of unapproved NDAs could provide valuable information about a drug if the application is a supplemental NDA or if it is for a new member of a class of products already on the market. Although pharmaceutical companies are required to submit to FDA information about all studies conducted under an IND, results of studies that are not submitted as part of a sponsor’s application package for approval or are finished after approval are not necessarily disclosed to the public. There is no way to know the results of clinical trials involving a drug if those results are not submitted to the FDA as part of an NDA or other review package or are not published in the scientific literature.
Several important efforts in recent years are aimed at increasing the availability of at least a minimum of information about current or complet-