for that report summary). The present report does not treat several very important issues that were not in the charge given to the committee, including the regulation or safety of medical devices or biological products other than those regulated by CDER; pharmaceutical product abuse, overuse, or misuse; over-the-counter (OTC) drugs or the switch from prescription to OTC status; generic drugs; drug pricing; or the causes and consequences of the current challenges in pharmaceutical innovation. Finally, although the postapproval stage of a drug’s life cannot be discussed in isolation from the preapproval stages, this report does not consider in any detail the complex ethical, practical, economic, and scientific issues related to the Investigational New Drug process or the clinical trial conduct in the testing of drugs.

Study Process

The committee gathered information to address its charge through a variety of means. It held three information-gathering meetings and one workshop that were open to the public. The first meeting focused on obtaining background on the committee charge from a number of perspectives, including FDA’s. This and all other meeting agendas can be found in Appendix D. The second meeting focused on hearing from the public on day 1, and learning about the role of FDA, AHRQ, and CMS in US drug safety activities on day 2. The committee also held a workshop on Advancing the Methods and Application of Risk-Benefit Assessment of Medicines and held a final information-gathering meeting to hear opinions on proposals to improve drug safety in the United States. The committee met in executive sessions for deliberative discussions throughout the study process.

All the open meetings were Webcast in real time so that members of the public could listen to the proceedings and send questions to the committee by e-mail. The committee also received public submissions of material for its consideration at the meetings and by mail, e-mail, and fax throughout the course of the study. A Web site ( and a list-serv were created to provide information to the public about the committee’s work and to facilitate communication with the committee. Many of the speakers’ presentation slides from the three information-gathering meetings and workshop are available in electronic format on the project’s Web site.

A few committee members and staff visited FDA to gain a better understanding of the background and daily operations of CDER. The committee and staff also conducted over 30 discussions with present and past FDA staff, managers, and leadership. Those discussions were confidential, but a summary of the main themes and points of discussion is provided in the public access file for this project (see IOM Staff Notes, 2005–2006).

The committee also commissioned two papers to inform it about industry’s views of drug safety in the United States (written by Hugh Tilson)

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