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Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

Index

A

AAMC. See Association of American Medical Colleges

Abbreviated NDAs, 32

“Academic detailing,” 183

Academic research enterprise, 2, 5, 28, 146.

See also Professional societies

Accelerated approval, 165

Accountability, by the FDA, need for greater, 4

Accutane, 120

ACE inhibitors, 38

Adverse drug reactions

monitoring, 98

Adverse event (AE) reporting, 54, 167

background incidence of, 114

electronic submission of, 109

prevalence of, 113

recommendations concerning, 7, 114115

substantial under-reporting, 55, 109

Adverse Event Reporting System (AERS), 5356, 98, 157, 184

Advertising. See Direct-to-consumer advertising;

Pharmaceutical advertising

Advisory committees, 4446, 179, 211

on communication with the public, 188

and the credibility of safety science, 131142

recommendations concerning, 910, 12, 133134, 188189

timeline for planning meetings of, 45

Advocacy movements, 177

for AIDS treatment, 22, 75

AE. See Adverse event reporting

AERS. See Adverse Event Reporting System

The agency. See Food and Drug Administration

Agency for Healthcare Research and Quality (AHRQ), 21, 25, 113, 180, 183, 212

AIDS treatment advocacy movement, 22, 75

ALLHAT. See Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial

Alosetron (Lotronex), 59

Amlodipine, 115

Antidepressants, warnings added to labels on, 17, 50

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), 115

Appropriations

as source of FDA funding, 13, 19, 23, 118, 193, 196, 198

Approval process, 27

accelerated, 165

confirmatory studies, 115119

safety signal generation, 108110

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

safety signal strengthening and testing, 110115

shortening, 107119

speed of, 16

APPROVe trials, 55

Association of American Medical Colleges (AAMC), 142, 211

Automated healthcare databases, 7, 114115

Azidothymidine (AZT), 37

B

Bain report, 32

Bayesian analysis, 109110

Best Pharmaceuticals for Children Act, 57, 152, 165

“Best practices,” disseminating, 8788

Bias, intellectual, 141

Biologics license application (BLA) submissions, 42

numbers of new approvals, 42

Biotechnology Industry Organization (BIO), 88

Bioterrorism and Preparedness and Response Act, 23

BLA. See Biologics license application submissions

Black box warnings, 50, 5859

Black triangle, 170171

Booz Allen Hamilton, 211

Boston Consulting Group, 123

British National Formulary, 170

Bromfenac, 38

Bureau of Labor Statistics, 92

Bush, President George W., 88, 207

C

C-Path Institute, 213

Calcium-channel blockers, 115

Cardiovascular risks, 112, 116

CBER. See Center for Biologics Evaluation and Research

CDC. See Centers for Disease Control and Prevention

CDER. See Center for Drug Evaluation and Research

CDRH. See Center for Devices and Radiological Health

Celecoxib, 17

Center for Biologics Evaluation and Research (CBER), 49, 129, 188

Center for Devices and Radiological Health (CDRH), 188

Center for Drug Evaluation and Research (CDER), ix–x, 15, 21, 31, 4647, 49, 65, 105, 179, 193202, 205.

See also Organizational dysfunction in the CDER culture;

Solutions proposed for CDER’s organizational dysfunction

credibility of, 85

history of funding, 194

IT needs within, 202

organizational culture in, 4, 66

press coverage of internal problems in, 2

recommendations concerning review teams, 10, 146147

relevant changes at, 210

shepherding products through trials, 154

staffing, 195, 199200

Center for Outcomes and Evidence, 212

Centers for Disease Control and Prevention (CDC), 81, 112, 128

Centers for Education and Research on Therapeutics (CERTs), 109

Centers for Medicare and Medicaid Services (CMS), 21, 25, 115, 180181, 201

Central Hudson Gas & Electric Corp. v. Public Service Commission, 159160

Cerivastatin, 17, 109

CERTs. See Centers for Education and Research on Therapeutics

CFR. See Code of Federal Regulations

Changes at the FDA

during course of study, 205215

Critical Path Initiative and partnerships, 212213

Drug Safety Initiatives, 205

Drug Safety Oversight Board, 205206

Drug Watch Web page, 206

labeling, 210

leadership changes in the FDA, 207208

other relevant changes at the FDA and CDER, 210

program reviews or evaluations, 211212

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

recent materials from the FDA, 208209

structural changes and leadership changes in the CDER, 206207

Changes in the broad context of drug regulation, 1921

The charge (to the committee), 2124

defining and meeting, 2128

disclaimers, 2425

the shifting landscape of drug safety, 26

study process, 2526

toward a new vision of drug safety, 2628

Chlorthalidone, 115

Cisapride, 50, 109, 168

Citizens’ Advisory Committee, 130

Clinical development, PDUFA goal for, 42

Clinical holds, 154

Clinical investigation (phase 2) studies, 35

Clinical pharmacology (phase 1) studies, 35

Clinical review templates, in postmarketing, 7980

Clinical trials, 76, 153

early, and related studies, 3435

formal (phase 3), 35

in IND submission and review, and their limitations, 3739

premarket, 38

recommendations regarding, 10, 144145

clinicaltrials.gov, 143, 145

Clozapine, 168

CMS. See Centers for Medicare and Medicaid Services

Code of Federal Regulations (CFR), 153, 159

COI. See Conflict of interest considerations

Commissioner of the FDA, 56, 9, 9293, 131.

See also individual commissioners

instability in the office of, 5, 8889

Committee on Identifying and Preventing Medication Errors, 24

Committee on Patient Education, 187

Committee on the Assessment of the US Drug Safety System, 2, 17, 65, 105, 178

charge to, 2124

Communication about safety, 27, 177192

FDA’s challenges in, 4, 184190

how industry communicates to the public and patients, 184, 188

improving, 187190

between providers and the drug safety system, 181184

between the public and the drug safety system, 178179

recommendations concerning, 1213, 188189

roles and needs of providers and patients, 178184

structure needed to support an effective drug safety system, 4

Confirmatory studies, 143n

reducing uncertainty about risk and benefit after approval, 115119, 122

Conflict of interest (COI) considerations, 45, 86, 93, 134142

appearance of, 73

“cover memos” regarding, 135139

recommendations concerning, 141142

zero-tolerance policy regarding, 140141

Congress, 2, 4, 8, 48, 66, 69, 95, 97, 117119, 153

ensuring that CDER receives needed authority and assets, x, 18

periodic reports to, 23, 71, 197, 202

recommendations to, 68, 1113, 98100, 117119, 169172, 197203

“Consults,” 7879, 82

Consumer Bill of Rights, 177

Consumer medication information, 185187

criteria for useful, 187

Consumer Price Index, 23

Consumer Product Safety Commission, 114

Consumers.

See also AIDS treatment advocacy movement;

The public empowering, 20

organizations of, 4, 66

representatives of, 179

Council of Public Representatives (COPR), 190

“Cover memos” regarding COI considerations, 135139

CPI. See Critical Path Initiative

Crawford, Acting FDA Commissioner Lester M., 207

Credibility of safety science, 126147

advisory committees, 131142

expertise in the CDER, 127131

transparency, 142147

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

Critical Path Initiative (CPI), 33, 70n, 105, 201, 207, 211213

report on, 20

Critical Path Opportunities Report, 212213

Culture of safety in CDER, 27, 65104

difficulties changing, 90

the external environment, 6875

organizational challenges, 65100

solutions proposed for CDER’s organizational dysfunction, 90100

structural factors, policies, and procedures, 7590

D

“DailyMed” health information clearinghouse, 210

Data management, 3940

Databases

automated, 56

mining, 57, 157

DCLG. See Director’s Consumer Liaison Group

DDMAC. See Division of Drug Marketing and Communication

DDRE. See Division of Drug Risk Evaluation

“Dear Health Practitioner” letters, 58, 158

DEcIDE. See Developing Evidence to Inform Decisions about Effectiveness Network

Decision-making

concerning postmarket safety of a drug, ix, 47

political considerations in, 90

regulatory, by the FDA, ix

science-based, 66, 129

Department of Defense (DoD), 118

Department of Health and Human Services (DHHS), 2, 18, 41, 71, 74n, 93n, 113, 153, 180, 205.

See also Secretary of Health and Human Services

Department of Health, Education, and Welfare (DHEW), 74n

Department of Veterans Affairs (VA), 21, 92, 112113, 201

“Detailing,” 18, 158, 183184

academic, 183

Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network, 113, 180

Development cost, of drugs, 32

DHEW. See Department of Health, Education, and Welfare

DHHS. See Department of Health and Human Services

Dietary supplements, 153

Differing professional opinion (DPO) procedure, 47n

Direct-to-consumer (DTC) advertising, 21, 5253, 158164, 167, 171172

court challenges to restricting, 159

deterrence of excessive, 198

need for more robust standards of assessment, 189

recommendations concerning, 1112, 169172

Director’s Consumer Liaison Group (DCLG), 190

Disagreement in the face of uncertainty, 127

nurturing a culture that values, 94

scientific, 8587

Discipline reviews, 79

different perspectives of, 86

Disclaimers, 2425

Disclosure requirements, 141

Dispute resolution, 84

in NDAs, 4748

Division of Drug Marketing and Communication (DDMAC), 52, 78, 159, 163, 179

“DDMAC Watch,” 162

Division of Drug Risk Evaluation (DDRE), 32, 36, 51, 56

Division of Neurology Products (DNP), 36

DoD. See Department of Defense

DPO. See Differing professional opinion procedure

Drug approval process

limitations on, 59

pressure to speed up, 22, 40

Drug Development Science Obstacles and Opportunities for Collaborations, 211

Drug industry. See Pharmaceutical industry

Drug Price Competition and Patent Term Extension Act, 152

Drug Regulation Reform Act, 156

Drug safety

communication about, 27, 177192

culture of safety in CDER, 27

experts in, 66

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

regulatory process and agency able to protect the public health, 27

rigorous science of, 27

the shifting landscape of, 26

toward a new vision of, 2628

warning the public about risks, 1

Drug safety activities, actionable performance goals for, 97

Drug Safety and Risk Management (DSaRM) Advisory Committee, 46, 87, 112, 133134, 187

Drug Safety Initiative, 205

Drug Safety Management Board, 144

Drug Safety Oversight Board (DSB), 47, 82, 8687, 99, 185, 187188, 205206

Drug safety system, 34, 17

committee convened to assess, 2

communicating with providers, 181184

communicating with the public, 178179

communication structure needed to support effectively, 4

financial resources required to enable CDER to support the FDA mission, 4

impairment in, 4

organizational culture of CDER, 4

regulatory authority necessary to provide for drug safety, 4

regulatory science and processes necessary to enhance drug safety, 4

resources for, 45, 1314, 166, 193204

Drug Watch Web site, 57, 99, 179, 185, 187, 205206

Drugs.

See also New drugs;

Prescription drugs;

Sponsors of drugs;

individual drugs cited

conditions linked to, 54

cost of, 178

development costs, 32

effectiveness of, 107

generics, 159

life-saving for specific patients, 1

“lifestyle,” 21

mechanisms of action, 2

milestones in lifecycle of, 167

over-the-counter, 90

pediatric, 165

potential benefit of, 34

promotion and information, postmarket, 5253

promotion to patients greatly increased, 21

DSaRM. See Drug Safety and Risk Management Advisory Committee

DSB. See Drug Safety Oversight Board

DTC advertising. See Direct-to-consumer advertising

E

Economic impact of drugs, 32

Electronic medical records, 117

Electronic submission, of adverse event reports, 109

“End of phase 2 meeting,” in IND submission and review, 3536

Enforcement tools, 163, 166167

decisions about, 58

Enhancing Drug Safety and Innovation Act, 201n

Environmental Protection Agency, 197n

Epidemic Intelligence Service program, 128

Epidemiologic studies, 76, 86, 115, 201

Epidemiologists, safety teams of, 88

European Medicines Agency, 54, 158, 173, 211

Evaluation of FDA’s First Cycle Review Performance—Retrospective Analysis, 209

Exceptions, in FDA’s regulatory authority, 165

Expectations of multiple constituencies, conflicting, 69

Expertise

in the CDER, and the credibility of safety science, 127131

in preapproval evaluation for the PDUFA IV, 98

External environment in CDER’s organizational dysfunction, 6875, 97100

the FDA-industry interface, 7075

F

Fast track studies, 39

FDA. See Food and Drug Administration

FDA Science Board, 129

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

FDAMA. See Food and Drug Administration Modernization Act

FD&C. See Food, Drug, and Cosmetic Act

Federal Advisory Committee Act, 116, 146, 190

Federal advisory committees, on consumer issues, examples of, 190

Federal Aviation Administration, organizational problems at, 67, 91

Federal Communications Commission, 92, 197n

Federal Register, 45, 156, 161, 186

Federal Trade Commission (FTC), 160

Financial resources. See Resources for the drug safety system

First Amendment protections, of truthful commercial speech, 159, 161162, 171, 183

Food and Drug Administration (FDA), ixx, 112, 15, 2325, 65, 105, 177, 180181, 205.

See also Commissioner of the FDA;

Recent FDA materials

approval but not a lifetime guarantee, 2

challenges in communicating to the public and patients, 184190

consumer medication information from, 185187

credibility of, 45, 70, 85, 88, 132

filing and review of submitted marketing applications, PDUFA goal for, 43

history of drug regulation by, 152153

history of DTC advertising regulation by, 160161

improving communication with the public, 187190

increasingly dependent on industry funding, 71

interface with industry, 7075

need for greater accountability and transparency by, 4

need for increased resources, 151, 193

oversight and review of clinical trial protocols during development, PDUFA goal for, ix, 42

public confidence in eroded, 15

“regulatory capture” of, 7374, 155, 196197

regulatory decision-making by, ix

relevant changes at, 210

reports from, 20, 209

response to public meeting input, 185

Science Board, 129

Food and Drug Administration (FDA) authority, 51, 151.

See also Direct-to-consumer (DTC) advertising;

Strengthening FDA’s regulatory authority

after approval, 155164

to compel completion of postmarketing commitments, 155157

exceptions in, 165

guidance documents, 41, 208209

oversight of sponsor promotional activities, 158164

preapproval, 37, 154155

recommendations concerning, 11, 170

to unilaterally impose risk-reducing remedies, such as label changes and distribution restrictions, 157158

Food and Drug Administration Modernization Act (FDAMA), 143, 152, 156

Food, Drug, and Cosmetic (FD&C) Act, 16, 2223, 48, 51, 69, 90, 152, 156, 159, 184

Drug Amendments to, 16, 152

Food Research Laboratory, 129

FTC. See Federal Trade Commission

Funding. See Resources for the drug safety system;

User-fee funding system

G

Galson, CDER Director Steven, 207

GAO. See Government Accountability Office

Gates Foundation, 212

“General applicability” matters, 134n

General Practice Research Database (GPRD), 112, 200

Generic drugs, 159

Goals. See Performance goals

Government Accountability Office (GAO), 36, 57, 66, 7172, 92, 158, 163

Government agencies

compared with private-sector counterparts, 6869

roles of, 180181

GPRD. See General Practice Research Database

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

GRMP. See Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products

Guidance documents, 208209

compared to MAPPs, 77n

writing, 41

Guidance for Industry: Consumer-Directed Broadcast Advertisements, 161

Guidance for Industry: Development and Use of Risk Minimization Action Plans, 119, 208

Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, 208

Guidance for Industry: Investigators, and Reviewers Exploratory IND Studies, 208

Guidance for Industry: Premarketing Risk Assessment, 208

Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products (GRMP), 78

Guidance on Conflict of Interest for Advisory Committee Members, Consultants and Experts, 134

H

Health, commodification of, 184n

Health care delivery system, 2, 5, 28, 69, 177

Health care entities, 45

Healthcare databases, automated, 7, 114115

Henney, FDA Commissioner Jane, 16, 89

Hinchey Amendment, 45

History of the Food and Drug Administration (FDA)

CDER funding, 194

CDER staffing, 195

drug regulation by, 152153

DTC advertising regulation, 160161

milestones in, 2223

HIV/AIDS crisis, 22.

See also AIDS treatment advocacy movement

HMO Research Network, 111112

Human subjects, protecting, 3334

Hypothesis-testing studies, 143

I

ICH. See International Conference on Harmonisation

IND. See Investigational New Drug submission and review process

Indications, re-examination for new, 167

The industry. See Pharmaceutical industry

Infliximab, 109

Information technology (IT).

See also Databases;

Medication information;

Reference information

needs within the CDER, 202

Ingenix Inc., 111112

Initial filing review, 4041

in NDAs, 4041

Innovation or Stagnation?—Challenge and Opportunity on the Critical Path to New Medical Products, 212

Instability at the top, and CDER’s organizational dysfunction, 8890

Institute of Medicine (IOM), ixx, 23, 21, 24, 50, 6667, 178, 182

Committee on Identifying and Preventing Medication Errors, 24

workshops, 143

Institutional review boards (IRBs), 33

Integrated Promotional Services, 56

Intellectual bias, 141

Interdisciplinary tension, 76

International Conference on Harmonisation (ICH), 54, 145, 208

International Society of Pharmacoepidemiology (ISPE), 112, 128

Interoffice polarization, and CDER’s organizational dysfunction, 8385

Investigational New Drug (IND) submission and review process, 2526, 3339

completion of clinical trials and their limitations, 3739

early clinical trials and related studies, 3435

“end of phase 2 meeting” and phase 3 trials, 3536

pre-new drug application submission meeting, 33, 39

roles of the OND and the ODS/OSE premarket, 3637

IOM. See Institute of Medicine

iPLEDGE, 121, 167168

IRBs. See Institutional review boards

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

Isotretinoin, 50, 120, 167168

ISPE. See International Society of Pharmacoepidemiology

IT. See Information technology

K

Kaiser Foundation Research Institute, 111112

L

Labeling, 4951, 167168.

See also Off-label use;

Symbol needed to denote limited knowledge about new drugs

changes, 167

FDA authority to unilaterally impose changes, 157158

negotiations, 50

recommendations concerning, 1112, 169172

relevant changes at the FDA and CDER, 210

Leadership

changes at the CDER, 206207

changes at the FDA, 207208

in solving CDER’s organizational dysfunction, 9194

Letters

“Dear Health Practitioner,” 58, 158

sent to drug sponsors in NDAs, 51

Lifecycle approach

to drug safety, conditions and restrictions on distribution throughout, 96, 167170

to drugs, 26, 126

to risk and benefit, 28, 96

“Lifestyle” drugs, 21

Lotronex, 59

M

Management Advisory Board, appointing an external, 6, 9394

Management issues in CDER’s organizational dysfunction, 7990

performance goals for the PDUFA IV, 100

solving, 9091

Management studies, 68, 8990, 95

Manual of Administrative Policies and Procedures (MAPPs), 47n, 77, 95

Mechanisms of action.

See also New molecular entities

of drugs, 2

MedDRA. See Medical Dictionary for Regulatory Activities

MedGuides, 50, 157, 186

Medical Dictionary for Regulatory Activities (MedDRA), 54, 57

Medical Officer Retention Subcommittee, 82

Medical records, move toward electronic, 117

Medicare Modernization Act, 113

Medicare Part D, 19, 113

Medication guide, 157.

See also MedGuides

Medication information, private-sector developers of, 186

Medicine Plus program, 181

Medicines and Health products Regulatory Agency (MHRA), 170

MedWatch reporting system, 5354, 109110, 184

MHRA. See Medicines and Health products Regulatory Agency

Murglitazar, 107

N

NAS. See National Academy of Sciences

Natalizumab, 168

National Academies Public Access Records Office, 26n

National Academy of Sciences (NAS), 92

National Aeronautics and Space Administration, organizational problems at, 67, 82

National Cancer Institute (NCI), 190

National Disease and Therapeutic Index, 56

National Electronic Injury Surveillance System–Cooperative Drug Adverse Event Surveillance System (NEISS–CADES), 114

National Health Service, 171

National Institute for Health and Clinical Excellence (UK), 125

National Institute of General Medical Sciences, 128

National Institutes of Health (NIH), 2021, 55, 81, 92, 116, 118, 180, 190

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

National Library of Medicine (NLM), 143, 145, 180181, 183

National Prescription Audit, 56

National Science Foundation (NSF), 92

Natural history of a drug, 3164

economic impact of drugs, 32

IND submission and review, 3339

new drug applications, 3951

postmarket period, 5159

NCI. See National Cancer Institute

NDAs. See New Drug Applications

Needs, of providers and patients, 178184

Negotiations, about label wording, 50

NEISS–CADES. See National Electronic Injury Surveillance System–Cooperative Drug Adverse Event Surveillance System

New Drug Applications (NDAs), 2223, 32, 3951, 106.

See also Abbreviated NDAs;

Supplemental NDAs

advisory committees, 4446

assembly of review team and beginning of review, 41, 4344, 77, 96

composition of review teams, 78, 83

dispute resolution, 4748

initial filing review, 4041

key review meetings, 48

letters sent to sponsors, 51, 79

PDUFA timetables and performance goals triggered, 40

postapproval requirements and labeling, 4951

review teams, 6, 41, 4344, 77, 96

RiskMAPs, 4849

safety tracking, 4647

site inspections, 51

New drugs, 2, 38, 107119, 165

New molecular entities (NMEs), 4144, 98, 106, 166

numbers of priority and standard approvals, 42

priority reviews of, 41, 133

recommendations concerning, 9, 12, 133134, 173

New vision of drug safety, 2628

NIH. See National Institutes of Health

NLM. See National Library of Medicine

NMEs. See New molecular entities

NSF. See National Science Foundation

O

ODS/OSE. See Office of Drug Safety/Office of Surveillance and Epidemiology

Off-label use, 122

Office of Drug Safety/Office of Surveillance and Epidemiology (ODS/OSE), 32, 4857, 67, 7578, 8386, 129, 146, 207

role in IND submission and review, 3639

staffing, 107

Office of Drug Safety Policy and Communication. See Office of Safety Policy and Communication

Office of Generic Drugs, 32

Office of the Inspector General (OIG), 71, 156

Office of Management and Budget, 18, 95

Office of New Drug Chemistry, 78

Office of New Drugs (OND), 3236, 51, 5657, 67, 7579, 8286, 105, 146, 194195, 206207

role in IND submission and review, 3637

Office of Safety Policy and Communication, 13, 185, 187, 189, 207

OIG. See Office of the Inspector General

OND. See Office of New Drugs

Opinion differences and CDER’s organizational dysfunction, 8587

Organizational dysfunction in the CDER culture, 4, 65100.

See also Solutions proposed for CDER’s organizational dysfunction

inconsistency, 8788

instability and politicization, 8890

internal disagreements about handling of safety issues, 47

interoffice polarization, 8385

management issues, 7981

mass media coverage of, 66, 84

policies, and procedures in solving, 7790

recommendations concerning, 57

scientific disagreement and differences of opinion, 8587

structural factors, 7577

suboptimal work environment, 8183

Orphan Drug Act, 152

Over-the-counter (OTC) drugs, 90, 153

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

P

Package inserts, for patients, 185

Patient Health Advisories, 206

Patient package inserts, 185

Patients, 2, 5

access to drugs, 16

advocacy movements for, 177

more engaged and knowledgeable, 21

need to reassure, 147

roles and needs of, 178184

PDUFA. See Prescription Drug User Fee Act

Pediatric drugs, 165

Peer-review, 118

recommendations concerning, 12, 173

Performance goals (suggested for) PDUFA IV, 98100

in performance report to Congress, 98100

safety-related, 98100

Pharmaceutical advertising.

See also Direct-to-consumer advertising

tax deductibility of, 199

Pharmaceutical drugs. See Drugs

Pharmaceutical industry, 2, 146, 177.

See also Sponsors of drugs;

User-fee funding system

communications with the public and patients, 158, 184, 186

credibility of, 45, 70

social responsibility of, 119

Pharmaceutical Research and Manufacturers of America (PhRMA), 89, 123, 143, 162163, 196

guiding principles on DTC advertising, 164

Pharmacoepidemiology

need for career-development awards in, 128

recommendations concerning, 9, 134141

Pharmacogenomics, 34

Pharmacovigilance, 208

Phases of clinical trials and medicine development, 35

phase 1–clinical pharmacology studies, 3435, 37

phase 2–clinical investigation studies, 3435, 37

phase 3–formal clinical trials, 3536, 124

phase 4–postmarketing surveillance, including further formal therapeutic trials, 35, 55, 106, 111, 117, 133, 157, 211

Plan B (emergency contraceptive), 8991

Planning advisory committee meetings, timeline for, 45

Polarization, interoffice, 66, 68, 8085

Policies and procedures, and CDER’s organizational dysfunction, 7779

Political considerations, in decision-making, 9091

Politicization, and CDER’s organizational dysfunction, 8890

Postmarketing safety of a drug, 5159, 9597

decision-making concerning, ix, 47

drug promotion and information, 5253

identifying and evaluating spontaneous safety signals, 5658

need to monitor, 59, 74, 156

postmarket data, 5556

recommendations concerning, 8, 127131

regulatory actions, 5859

requirements and labeling, in NDAs, 25, 4951

risk communication activities and risk management for the PDUFA IV, 99

spontaneous adverse event reporting system, 5355

Postmarketing study commitments, 155, 172173, 211

for the PDUFA IV, 99

Postmarketing surveillance, including further formal therapeutic trials (phase 4), 35

PPP. See Pregnancy Prevention Program;

Public-private partnership

Pre-new drug application submission meeting, 39

Preapproval period, 37, 123, 154155

safety conferences during, 48

Predictive Safety Testing Consortium, 213

Pregnancy Prevention Program (PPP), 120

Premarket clinical trials, 38

Prescribers’ understanding, 5

Prescription Drug User Fee Act (PDUFA), 15, 66, 7074, 116, 154155, 193.

See also User-fee funding system

clinical development of, 42

deadlines in, 49

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

FDA filing and review of submitted marketing applications, 43

FDA oversight and review of clinical trial protocols during development, 42

goals of, 4243

in NDAs, 40

PDUFA I, 16, 23, 72

PDUFA II, 16, 23, 3536, 40, 7273

PDUFA III, 3536, 40, 4849, 73, 121

PDUFA IV, 98100

Reauthorization Performance Goals and Procedures, 23

short history of, 7273

sponsor-requested meetings with FDA during clinical development, 4243

sunset of approaching, 19

timetables and performance goals triggered, 40

Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications, 209

Prescription drugs

off-label use, 122

providers’ knowledge about, 179

safety of, 12

taking multiple, 153

Prescriptions, taxing, 198

Preventing Medication Errors, 50, 178, 182

recommendations from, 180183

Princeton Survey Research Associates, 162

Priority reviews, 133

of new molecular entities, 41

Product seizures, 58

Product submissions, reductions in, 133

Professional opinions. See Differing professional opinion procedure

Professional societies, 45

Program reviews or evaluations, 211212

advisory committees, 211

partnerships, 211212

postmarketing study commitments, 211

Project managers, 34

Promotion of drugs to patients.

See also Direct-to-consumer advertising;

Pharmaceutical advertising

increases in, 21

Propulsid, 17

Protection of human subjects, 33

Providers, roles and needs of, 178184

The public, 2, 5, 28

improving communication with, 187190

perspectives on DTC advertising, 162

Public Employees for Environmental Responsibility, 86n

Public Health Advisories, 206

Public-private partnership (PPP), 8, 117119, 201

Pure Food and Drug Act, ix, 19n, 22, 152, 184

Q

Quality-adjusted life years (QALYs), 125

R

Randomized controlled trials, 86

Rationale for strengthening drug regulation, 164166

realistic regulatory action on safety needed, without the “last call” of approvals, 166

Reauthorization Performance Goals and Procedures (PDUFA), 23, 196199

Recent FDA materials, 208209

guidance documents, 41, 208209

reports, 209

Recommendations, 514

adverse event reporting, 7, 114115

advisory committees, 910, 12, 133142, 188189

AERS, 7, 110

amending the FD&C Act, 56, 9293

automated healthcare databases, 7, 114115

better science and expertise, 710

CDER review teams, 10, 146147

clinical trials, 10, 144145

for the Commissioner of the FDA, 56, 9, 9293, 131

communication about safety, 1213, 188189

conflicts of interest, 10, 141142

for Congress, 68, 1113, 98100, 117119, 169172, 197203

for consumers, 180181

direct-to-consumer advertising, 1112, 169172

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

external Management Advisory Board, 6, 9394

FDA authority, 11, 170

labeling, 11, 169170

NDA, 10, 144146

NDA review teams, 6, 96

new molecular entities, 9, 12, 133134, 173

Office of Drug Safety Policy and Communication, 13, 189

organizational culture, 57

peer-review, 12, 173

pharmacoepidemiology, 9, 134141

postmarketing safety of a drug, 8, 127131

from Preventing Medication Errors, 180183

for providers and patients, 182183

public-private partnership, 8, 117119

regulation, 1012

resources, 1314, 197203

risk-benefit analyses, 8, 125126

risk management, 11, 169170

RiskMAPs, 8, 121

safety-related performance goals for the PDUFA IV, 67, 98100

for the Secretary of DHHS, 6, 8, 9394, 117119

Reference information, access to comprehensive, 182

Regulatory activities for safety, 4, 31.

See also Enforcement tools

in the postmarket period, 5859

realistic needed, without the “last call” of approvals, 166

recommendations concerning, 1012

Regulatory authority necessary to provide for drug safety, 4, 27, 151176.

See also Food and Drug Administration authority

an aging and inadequate statutory framework, 153166

history of FDA drug regulation, 152153

strengthening FDA’s regulatory authority, 167173

“Regulatory briefings,” 46

“Regulatory capture” of the FDA, 7374, 155, 196197

Regulatory “tool kit,” 168, 213

Research. See Academic research enterprise

Resources for the drug safety system, 5, 166, 193204

levels required to enable CDER to support the FDA mission, 4

recommendations concerning, 1314, 197203

Review elements for new drug approval

beginning in NDAs, 41, 4344

current, 52

data on NMEs, 172173

meetings key in NDAs, 48

Review Panel on New Drug Regulation, 74, 155156, 172

Review teams, 34

composition of, 78, 83

in NDAs, assembling, 41, 4344

Risk-benefit analyses

for approval decisions, 106107, 166

evolving throughout the drug’s lifecycle, 2, 4, 96, 121126

recommendations concerning, 8, 125126

Risk communication activities, 27

postmarket, 97

Risk management

postmarket, 97

recommendations concerning, 11, 169170

Risk Minimization Action Plans (RiskMAPs), 119121, 146, 167

developing and assessing, 57, 158

in NDAs, 4849

Rofecoxib, 17, 55, 168

Roles, of providers and patients (in drug safety system), 5, 178184

Rolling reviews, 3940

S

Safety data, gaps in, 37

Safety officers, 37

Safety-related performance goals for the PDUFA IV, 98100

expertise in preapproval evaluation, 98

monitoring of adverse drug reactions and the AERS, 98

performance management, 100

postmarketing risk communication

activities and risk management, 99

postmarketing study commitments, 99

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

Safety signals, 27, 84.

See also Spontaneous safety signals in the postmarket period

in generation, 108110

reducing uncertainty about and benefit after approval, 108115

in strengthening and testing, 110115

Safety teams, of epidemiologists, 88

Safety “tool kits,” 213

Safety tracking, 4647

in NDAs, 4647

Science-based decision-making, 66, 129

Science of safety, 27, 105150

benefits after approval, 107119, 122

credibility of, 126147

generating, 106126

and recommendations concerning expertise, 710

reducing uncertainty about, 107119, 122

rigor in, 27

risk-benefit analyses throughout the drug’s lifecycle, 121126

risk minimization action plans, 119121

understanding risk and benefit for approval decisions, 66, 106107

Scientific advances, 28.

See also Academic research enterprise

increasing the numbers of targeted drugs, 20

Scientific disagreement, and CDER’s organizational dysfunction, 8587

Scientific reviewers, 34

Secretary of Health and Human Services, 6, 45, 9394, 97

Sector maps, 110

Signals. See Safety signals

Site inspections, 51

in NDAs, 51

SMART (System to Manage Accutane Related Teratogenicity), 120121

Social Security Administration, 92

Solutions proposed for CDER’s organizational dysfunction, 90100

agency leadership, 9194

external environment, 97100

management, 9091

structural factors, 9497

“Special Government Employees,” 131, 211

Special symbol needed to denote limited knowledge about new drugs, 170172.

See also Black triangle

Sponsors of drugs

letters sent to, 51

materials generated by, 52

meeting with FDA during clinical development, PDUFA goal for, 4243

non-compliance by, 18

obligations of, 34

Spontaneous safety signals in the postmarket period

AERS, 5355

identifying and evaluating, 5658

Stakeholders, 2, 4, 177.

See also individual stakeholders

Statement of task. See The charge (to the committee)

Statutory framework (for drug regulation)

aging of, 153166

FDA authority after approval, 155164

FDA authority preapproval, 154155

inadequacy of, 153166

rationale for strengthening, 164166

Steering Committee for the Collaborative Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information, 186

Strengthening FDA’s regulatory authority, 167173

conditions and restrictions on distribution throughout the drug lifecycle, 167170

greater regulatory flexibility post approval, 166

periodic review of data on NMEs, 172173

special symbol needed to denote limited knowledge about new drugs, 170172

Structural changes in the CDER, 206207

Structural factors in CDER’s organizational dysfunction, 7577

solving, 9497

Study process, 2526

Supplemental NDAs, 31

Supplements, dietary, 153

Surrogate endpoints, 107

Suspension of approval, 173

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

T

Taxing prescriptions, 198

“Team approach,” 76.

See also Review teams;

Safety teams

Terfenadine, 109

Terminology coding, 54

Thompson v. Western States Medical Center, 160

Throckmorton, CDER Deputy Director Douglas, 207

Timeline, for planning advisory committee meetings, 45

Toxicologic studies, 44

Transparency

and the credibility of safety science, 142147

need for greater, 45, 124, 127

Troglitazone, 17, 50, 109

Tufts Center for the Study of Drug Development, 71

U

Uncertainty, disagreement in the face of, 127

Under-reporting of adverse events, substantial, 55, 109

Union of Concerned Scientists, 86n

University of Arizona, 213

US drug safety system.

See also Committee on the Assessment of the US Drug Safety System

impaired by, 4

an improved, 1314

a transformed, 4

Useful consumer medication information, criteria for, 187

User-fee funding system, 16, 23, 40, 70, 83, 196197

V

VA. See Department of Veterans Affairs

Vaccine Safety Datalink (VSD), 112

Valdecoxib, 17

Vanderbilt University, 111

Veterans Health Administration, 92

Vioxx, 65

Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 159

Vision. See New vision of drug safety

von Eschenbach, FDA Acting Commissioner Andrew, 86n

VSD. See Vaccine Safety Datalink

W

Wall Street Journal, 162

Warning the public about drug safety risks, 1.

See also Black box warnings;

Labeling

Washington Legal Foundation, 162

Web sites, 25, 140, 142143, 159, 172, 179, 181, 187, 190, 210

WHI. See Women’s Health Initiative

WHO. See World Health Organization

Withdrawals, 12, 16, 165, 173

Women’s Health Initiative (WHI), 55, 115, 123124, 181

World Health Organization (WHO), 143, 145, 212

Z

Zero-tolerance policy, regarding COI considerations, 140141

Suggested Citation:"Index." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' risk–benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

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