The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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Index
Index
Pages 319-332
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Index A recommendations concerning, 9–10, 12, 133–134, 188–189 AAMC. See Association of American timeline for planning meetings of, 45 Medical Colleges Advocacy movements, 177 Abbreviated NDAs, 32 for AIDS treatment, 22, 75 "Academic detailing," 183 AE.
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0 THE FUTURE OF DRUG SAFETY safety signal strengthening and testing, Celecoxib, 17 110–115 Center for Biologics Evaluation and shortening, 107–119 Research (CBER) , 49, 129, 188 speed of, 16 Center for Devices and Radiological Health APPROVe trials, 55 (CDRH)
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INDEX recent materials from the FDA, improving, 187–190 208–209 between providers and the drug safety structural changes and leadership system, 181–184 changes in the CDER, 206–207 between the public and the drug safety Changes in the broad context of drug system, 178–179 regulation, 19–21 recommendations concerning, 12–13, The charge (to the committee) , 21–24 188–189 defining and meeting, 21–28 roles and needs of providers and disclaimers, 24–25 patients, 178–184 the shifting landscape of drug safety, 26 structure needed to support an study process, 25–26 effective drug safety system, 4 toward a new vision of drug safety, Confirmatory studies, 143n 26–28 reducing uncertainty about risk and Chlorthalidone, 115 benefit after approval, 115–119, Cisapride, 50, 109, 168 122 Citizens' Advisory Committee, 130 Conflict of interest (COI)
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THE FUTURE OF DRUG SAFETY Critical Path Initiative (CPI) , 33, 70n, 105, Development cost, of drugs, 32 201, 207, 211–213 DHEW.
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See also New drugs; Prescription in the CDER, and the credibility of drugs; Sponsors of drugs; individual safety science, 127–131 drugs cited in preapproval evaluation for the conditions linked to, 54 PDUFA IV, 98 cost of, 178 External environment in CDER's development costs, 32 organizational dysfunction, 68–75, effectiveness of, 107 97–100 generics, 159 the FDA-industry interface, 70–75 life-saving for specific patients, 1 "lifestyle," 21 mechanisms of action, 2 F milestones in lifecycle of, 167 over-the-counter, 90 Fast track studies, 39 pediatric, 165 FDA. See Food and Drug Administration potential benefit of, 34 FDA Science Board, 129
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, remedies, such as label changes and ix–x, 1–12, 15, 23–25, 65, 105, distribution restrictions, 157–158 177, 180–181, 205. See also Food and Drug Administration Commissioner of the FDA; Recent Modernization Act (FDAMA)
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, 54, 145, 208 Health, commodification of, 184n International Society of Health care delivery system, 2, 5, 28, 69, Pharmacoepidemiology (ISPE) , 112, 177 128 Health care entities, 4–5 Interoffice polarization, and CDER's Healthcare databases, automated, 7, organizational dysfunction, 83–85 114–115 Investigational New Drug (IND)
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THE FUTURE OF DRUG SAFETY Isotretinoin, 50, 120, 167–168 Manual of Administratie Policies and ISPE. See International Society of Procedures (MAPPs)
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INDEX O National Library of Medicine (NLM)
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See regulatory actions, 58–59 also Sponsors of drugs; User-fee requirements and labeling, in NDAs, funding system 25, 49–51 communications with the public and risk communication activities and risk patients, 158, 184, 186 management for the PDUFA IV, 99 credibility of, 4–5, 70 spontaneous adverse event reporting social responsibility of, 119 system, 53–55 Pharmaceutical Research and Postmarketing study commitments, 155, Manufacturers of America 172–173, 211 (PhRMA) , 89, 123, 143, 162–163, for the PDUFA IV, 99 196 Postmarketing surveillance, including guiding principles on DTC advertising, further formal therapeutic trials 164 (phase 4)
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INDEX FDA filing and review of submitted The public, 2, 5, 28 marketing applications, 43 improving communication with, FDA oversight and review of clinical 187–190 trial protocols during development, perspectives on DTC advertising, 162 42 Public Employees for Environmental goals of, 42–43 Responsibility, 86n in NDAs, 40 Public Health Advisories, 206 PDUFA I, 16, 23, 72 Public-private partnership (PPP) , 8, 117– PDUFA II, 16, 23, 35–36, 40, 72–73 119, 201 PDUFA III, 35–36, 40, 48–49, 73, 121 Pure Food and Drug Act, ix, 19n, 22, 152, PDUFA IV, 98–100 184 Reauthorization Performance Goals and Procedures, 23 Q short history of, 72–73 sponsor-requested meetings with FDA Quality-adjusted life years (QALYs)
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See S also Food and Drug Administration authority Safety data, gaps in, 37 an aging and inadequate statutory Safety officers, 37 framework, 153–166 Safety-related performance goals for the history of FDA drug regulation, PDUFA IV, 98–100 152–153 expertise in preapproval evaluation, 98 strengthening FDA's regulatory monitoring of adverse drug reactions authority, 167–173 and the AERS, 98 "Regulatory briefings," 46 performance management, 100 "Regulatory capture" of the FDA, 73–74, postmarketing risk communication 155, 196–197 activities and risk management, 99 Regulatory "tool kit," 168, 213 postmarketing study commitments, 99 Research. See Academic research enterprise
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INDEX Safety signals, 27, 84. See also Spontaneous Special symbol needed to denote limited safety signals in the postmarket knowledge about new drugs, period 170–172.
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THE FUTURE OF DRUG SAFETY T V Taxing prescriptions, 198 VA. See Department of Veterans Affairs "Team approach," 76.
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