and those of academe (written by Brian Strom); these papers were based in part on small meetings convened by the authors and can be found in the public access file.3

Moving Target—The Shifting Landscape of Drug Safety in the United States

The committee has worked in the context of continuing change and proposals for change: modifications in the organizational structure of CDER and in the evaluation and monitoring of drug safety undertaken by FDA and to a lesser extent other stakeholders; multiple legislative proposals for changing the structure, resources, and authorities of CDER in FDA; and consumer and patient organizations’ calls for changes in CDER. Those efforts have, in some cases, informed the work of the committee during its deliberations. Some of these changes have closed gaps, others have raised new questions and concerns, and still others have helped to increase the knowledge base of the committee. The efforts are described in greater detail in Appendix A.

Toward a New Vision of Drug Safety

The increasingly complex interface between innovation and regulation has been characterized by binary opposites: speed vs. safety, tight preapproval regulation vs. loose postapproval regulation, active collection of data before approval vs. passive surveillance after approval, and an abundance of clinical efficacy data before approval compared to much fewer safety data after approval. The polarity of approach and emphasis is inconsistent with the widely accepted notions that risk must be considered in the context of benefits, that understanding of the risks and benefits associated with a drug changes over a drug’s lifecycle (FDA, 2004), and that the attention paid to safety and efficacy before approval must therefore be sustained as a drug enters and diffuses through the market and is used by a growing number and diversity of patients. Timely approval and attention to safety can become complementary rather than antithetical goals as postapproval surveillance becomes more effective, and regulatory authority and its exercise is commensurate with how a drug performs in real-life conditions over its lifecycle.

3

A list of materials reviewed by the committee (in the form in which they were reviewed), including all submissions of information from the public and many items not cited in this report, can be found in the study’s public access file, obtained from the National Academies Public Access Records Office at (202) 334-3543 or http://www8.nationalacademies.org/cp/ManageRequest.aspx?key=162.



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