FDA Administrative Enforcement Manual

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ISBN: 9780849330674 | 084933067X
Cover: Hardcover
Copyright: 2/18/2005

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A self-contained single source complete with pertinent references and practical outlines for policies and procedures, this book covers how to understand and comply with U.S. drug development and manufacturing regulations. It explores the control of drug research and the manufacturing industry, introduces basic industry experience and techniques, and presents tried and true methods for applying the theory to everyday problems. The author discusses the 10 critical administrative enforcement areas, including recall, application integrity, injunction, seizure, and more, then supplements the topics with regulations, lawsuit case studies, enforcement information, and reference material.

Introduction

xix

Department of Health and Human Services, U.S. Food and Drug Administration: Authority and Responsibility

(40)

Statutory Authority

(1)

Laws Enforced by the FDA

(12)

Recommendations for Understanding the Act

(1)

U.S. Drug Law History

(1)

Jurisdiction

(1)

Statute of Limitations

(1)

Administrative Law and Procedures Act

(1)

Code of Federal Regulations

(1)

Authority, Scope, and Facility Inspections

(1)

Inspection Process and Procedures

(2)

U.S. Constitutional Rights of Defendant Firms and Individuals

(1)

Evidence, Administrative Agencies, and Federal Courts

(1)

Case Studies

(24)

DHHS--FDA Exhibits

(6)

Summary

(1)

Practicum

(1)

The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective

(4)

WLF v. Henney

(4)

Did You Know

(1)

Notes: Drug Law

(1)

Endnotes

(1)

Other Resources

(1)

General

(1)

Drug, Biologic, and Cosmetic Regulations

(2)

Food, Device, and Veterinary Medicine Regulation

(1)

Off-Label Uses

(4)

Recalls: Corrections and Withdrawals

(34)

Statutory Authority

(1)

Recall Type and Class

(9)

Recall Types

(6)

Regulated Product Problem Notification

(1)

Preventative Controls

(1)

Defective Controls

(1)

Controllable vs. Uncontrollable Regulated Product Problems

(2)

Recall Classes

(1)

Prior Notice

(1)

Class I FDA-Requested Recall

(1)

Class II Firm-Initiated Recall

(1)

Class III Firm-Initiated Recall

(1)

Communication

(1)

Recall Effectiveness Monitoring

(1)

Strategy

(1)

Public Notification

(1)

Status Reports

(1)

Termination

(1)

Regulated Product Withdrawals

(1)

FDA Recall Facts

(1)

Case Studies

(22)

Recall Exhibits

(11)

Summary

(1)

Practicum

(1)

Title 21 CFR 7

(5)

Company Z Recall

(2)

Endnotes

(1)

Other Resources

(1)

U.S. Federal Government Laws, Regulations, and Guides Concerning Protection of Human Subjects: Journal Articles

(1)

U.S. Federal Government Laws, Regulations, and Guides Concerning Protection of Human Subjects: Books

(1)

Civil Actions

(58)

Seizure

(14)

Statutory Authority

(1)

Jurisdiction

(1)

Purpose of Seizure

(1)

Seizures: Lot, Multiple, and Mass

(1)

Disposition of Seized (Arrested) Goods

(1)

Penal Bond

(1)

Seizure Violations

(1)

Case Studies

(1)

Seizure Exhibits

(10)

Summary

(1)

Reading Reference Section

(1)

Discussion Questions

(1)

Injunctions

(44)

Statutory Authority

(1)

Jurisdiction

(1)

Civil Action Penalties and Fines

(2)

Contest Injunction or Opt for Consent Decree

(1)

Case Study: Schering Plough Corporation Permanent Injunction

(22)

Consent Decree and Its Resolution

115

(1)

Prohibitory Actions

115

(1)

Mandatory Actions

116

(1)

Fines and Penalties

116

(1)

Requirements after the Consent Decree

116

(1)

Background for Case Study

117

(1)

Program Implementation Case Study

118

(1)

Overview of the Problem

118

(1)

Prior Notice Information

119

(1)

Analysis

119

(2)

CGMP Workplan To Resolve Injunction

121

(1)

Suggested Solution

121

(2)

Nonconformance

123

(3)

Summary of Consent Decree Solutions

126

(3)

Endnotes

129

(4)

Criminal Actions: Debarment, Disqualification, and Application Compliance and Integrity

133

(56)

Statutory Authority

133

(1)

Jurisdiction

133

(1)

Debarment

134

(10)

Generic Drug Enforcement Act of 1992

134

(1)

Who May Be Debarred

134

(2)

Debarment for Direct or Indirect Conduct

136

(1)

Debarment Types: Mandatory and Permissive

137

(1)

Criminal Mental State Required To Convict

137

(1)

Scope of Debarment

138

(1)

People, Services, and Those Affiliated or Who May Be Affected by Debarment

138

(1)

Debarment Crimes

139

(1)

306(k)(2) Conviction Information Requirements

139

(1)

Debarment Effects

140

(1)

Debarment Periods

140

(1)

Debarring Period Consideration Factors

140

(1)

Terminating Debarment

141

(1)

Suspension Authority for ANDA Product Distribution

141

(3)

Disqualifications

144

(2)

IRB Responsibilities

144

(1)

Regulatory Responsibilities of IRB to Human Clinical Trial Patients and Clinical Investigators

144

(1)

Regulatory Sanctions IRBs May Face in a Disqualification Action

145

(1)

Impact of IRB Disqualification

145

(1)

Clinical Investigator Responsibilities

145

(1)

Regulatory Responsibilities of Clinical Investigators

146

(1)

Regulatory Sanctions Clinical Investigators May Face in a Disqualification Action

146

(1)

Impact of Clinical Investigator Disqualification

146

(1)

Applications: Compliance and Validity Issues

146

(11)

Application Compliance

146

(6)

Application Integrity Policy

152

(1)

Applications Involved in AIP Reviews

153

(1)

Deferral of Scientific Review

153

(1)

Untrue Statement or Material Fact

153

(1)

Validity Assessment

153

(1)

Wrongful Acts

153

(1)

Invoking and Revoking AIP

154

(2)

Corrective Actions

156

(1)

Case Studies

157

(32)

Summary

186

(1)

Reading Reference Section

186

(1)

Practicum

186

(1)

Investigators' Reports: Counterfeit Baby Formula Lands Fugitive in Jail

186

(2)

Endnotes

188

(1)

Case Studies

189

(54)

Program Implementation

189

(1)

FDA 483 Forms, Recalls, Corrections, and Market Withdrawals

189

(11)

Abbott Laboratories, Inc., FDA 483 Notice of Observations

189

(5)

Abbott Laboratories, Inc., Recalls

194

(1)

Abbott Laboratories Firm-Initiated Recall of HIV p24 Antigen Test Kit

195

(1)

Abbott Laboratories, Inc., Warning Letter

196

(2)

Schering Corporation Recall of Interferon alfa-2b (Recombinant), Powder for Injection, Intron A

198

(1)

Wyeth-Ayerst Firm-Initiated Recall of Haemophilus b Conjugate Vaccine

198

(1)

Wyeth-Ayerst Withdrawal of Rotavirus Vaccine, Live, Oral, Tetravalent (RotaShield)

199

(1)

Mass Seizure Actions

200

(1)

Injunction Actions

201

(1)

Consent Decrees

202

(10)

Warner-Lambert Consent Decree

202

(1)

Parkedale Pharmaceuticals, Inc., Consent Decree Notification Letter 1

203

(6)

Parkedale Pharmaceuticals, Inc., Consent Decree Notification Letter 2

209

(3)

Criminal Indictments, Process, and FDA Procedures

212

(2)

FDA Prosecution

214

(3)

Office of Criminal Investigations

214

(1)

Criminal Prosecution after Section 305 Notice

214

(1)

Criminal Prosecution without Section 305 Notice

215

(1)

Contempt of Court and Violation of Probation

216

(1)

Development of Felony Violation

216

(1)

Debarment

217

(26)

Example 1

217

(1)

Example 2

218

(4)

Case Study Exhibits

222

(19)

Endnotes

241

(2)

Appendix 1. FD&C Act of 1938

243

(132)

Chapter III. Prohibited Acts and Penalties

243

(1)

Seizure

243

(13)

Hearing Before Report of Criminal Violation

246

(1)

Debarment, Temporary Denial of Approval, and Suspension

246

(7)

Civil Penalties

253

(2)

Authority To Withdraw Approval of Abbreviated Drug Applications

255

(1)

Report of Minor Violations

255

(1)

Proceedings in Name of United States; Provision as to Subpoenas

255

(1)

Chapter V. Drugs and Devices

256

(54)

Subchapter A. Drugs and Devices

256

(1)

Adulterated Drugs and Devices

256

(2)

Misbranded Drugs and Devices

258

(3)

Exemptions and Considerations for Certain Drugs, Devices, and Biological Products

261

(7)

Veterinary Feed Directive Drugs

268

(1)

New Drugs

268

(25)

Authority To Designate Official Names

293

(1)

Nonapplicability to Cosmetics

294

(1)

Registration of Producers of Drugs and Devices

294

(3)

New Animal Drugs

297

(1)

Classification of Devices Intended for Human Use

297

(1)

Device Classes

297

(2)

Classification; Classification Panels

299

(2)

Classification Panel Organization and Operation

301

(1)

Classification

302

(1)

Classification Changes

302

(1)

Initial Classification and Reclassification of Certain Devices

302

(2)

Information

304

(1)

Definitions

305

(1)

Performance Standards

306

(1)

Provision of Standards

306

(1)

Establishment of a Standard

307

(2)

Recognition of a Standard

309

(1)

Premarket Approval

310

(1)

General Requirement

310

(52)

Regulation to Require Premarket Approval

310

(1)

Application for Premarket Approval

311

(1)

Action on Application for Premarket Approval

311

(3)

Withdrawal and Temporary Suspension of Approval of Application

314

(1)

Product Development Protocol

314

(3)

Review

317

(1)

Service of Orders

318

(1)

Revision

318

(1)

Banned Devices

318

(1)

General Rule

318

(1)

Special Effective Date

319

(1)

Judicial Review

319

(1)

Application of Section

319

(1)

Additional Data, Views, and Arguments

320

(1)

Standard for Review

320

(1)

Finality of Judgment

320

(1)

Remedies

320

(1)

Statement of Reasons

320

(1)

Notification and Other Remedies

321

(1)

Notification

321

(1)

Repair, Replacement, or Refund

321

(1)

Reimbursement

322

(1)

Effect on Other Liability

322

(1)

Recall Authority

323

(1)

Records and Reports on Devices

323

(1)

General Rule

323

(1)

User Reports

324

(2)

Persons Exempt

326

(1)

Device Tracking

326

(1)

Reports of Removals and Corrections

327

(1)

General Provisions Respecting Control of Devices Intended for Human Use

327

(1)

General Rule

327

(1)

Custom Devices

327

(1)

Trade Secrets

328

(1)

Notices and Findings

328

(1)

Restricted Devices

328

(1)

Good Manufacturing Practice Requirements

329

(1)

Exemption for Devices for Investigational Use

330

(3)

Release of Information Respecting Safety and Effectiveness

333

(1)

Proceedings of Advisory Panels and Committees

334

(1)

Traceability

334

(1)

Research and Development

334

(1)

Transitional Provisions for Devices Considered as New Drugs

334

(3)

Humanitarian Device Exemption

337

(1)

State and Local Requirements Respecting Devices

338

(1)

General Rule

338

(1)

Exempt Requirements

338

(1)

Postmarket Surveillance

338

(3)

Subchapter B. Drugs for Rare Diseases or Conditions

341

(1)

Recommendations for Investigations of Drugs for Rare Diseases or Conditions

341

(1)

Designation of Drugs for Rare Diseases or Conditions

341

(1)

Protection for Drugs for Rare Diseases or Conditions

342

(1)

Open Protocols for Investigations of Drugs for Rare Diseases or Conditions

342

(1)

Subchapter C. Electronic Product Radiation Control

343

(1)

Definitions

343

(1)

Electronic Product Radiation Control Program

343

(1)

Studies by the Secretary

344

(1)

Performance Standards for Electronic Products

345

(2)

Notification of Defects in and Repair or Replacement of Electronic Products

347

(2)

Imports

349

(1)

Inspection and Reports

350

(1)

Prohibited Acts

351

(1)

Enforcement

351

(1)

Annual Report

352

(1)

Federal--State Cooperation

353

(1)

State Standards

353

(1)

Subchapter D. Dissemination of Treatment Information

353

(7)

Subchapter E. General Provisions Relating to Drugs and Devices

360

(2)

Chapter III. Imports and Exports

362

(7)

Imports and Exports

362

(2)

Exports of Certain Unapproved Products

364

(4)

Office of International Relations

368

(1)

Chapter IX. Miscellaneous

369

(6)

Separability Clause

369

(1)

Effective Date and Repeals

369

(6)

Appendix 2. Drug Law History Synopsis

375

(6)

Appendix 3. Clinical Investigators

381

(10)

Clinical Investigator Regulatory Sanctions

381

(3)

The Disqualification Process

381

(1)

Informal Conference or Written Explanation

381

(1)

Notice of an Opportunity for Hearing on Proposed Disqualifications

381

(1)

Part 16 Hearing and Final Order on Disqualification

382

(1)

Actions Upon Disqualification

382

(1)

Public Disclosure of Information Regarding Disqualification

383

(1)

Reinstatement of a Disqualified Investigator

383

(1)

Consent Agreements

383

(1)

Criminal Prosecutions

384

(1)

Additional Information

384

(1)

Investigator Responsibilities

384

(2)

FDA Inspections of Clinical Investigators

386

(2)

Background

386

(1)

Clinical Investigator Inspection Programs

386

(1)

Study-Oriented Inspections

387

(1)

Investigator-Oriented Inspections

387

(1)

Inspection Findings

388

(1)

Additional Information

388

(1)

FDA Institutional Review Board Inspections

388

(3)

Background

388

(1)

IRB Review Program

389

(1)

Additional Information

389

(1)

Contact Person for Inspection Problems

390

(1)

Appendix 4. FDA Administrative Procedures Act (FAPA)

391

(42)

Title 21 (Food and Drugs) CFR 10.1--10.206

391

(42)

Subchapter A -- General

391

(1)

Subpart A -- General Provisions

391

(2)

Subpart B -- General Administrative Procedures

393

(34)

Subpart C -- Electronic Media Coverage of Public Administrative

427

(6)

Glossary

433

(16)

Index

449

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FDA Administrative Enforcement Manual

Summary

Table of Contents

Supplemental Materials