1st Edition

FDA Administrative Enforcement Manual

By Florence R. Parker Copyright 2005
    480 Pages 15 B/W Illustrations
    by CRC Press

    When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought.
    Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them.

    The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.

    Introduction

    DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION: AUTHORITY AND RESPONSIBILITY
    Statutory Authority
    Laws Enforced by the FDA
    Jurisdiction
    Statute of Limitations
    Administrative Law and Procedures Act
    Code of Federal Regulations
    Authority, Scope, and Facility Inspections
    Inspection Process and Procedures
    U.S. Constitutional Rights of Defendant Firms and Individuals
    Evidence, Administrative Agencies, and Federal Courts
    Case Studies

    RECALLS: CORRECTIONS AND WITHDRAWALS
    Statutory Authority
    Recall Type and Class
    Recall Effectiveness Monitoring
    Strategy
    Public Notification
    Status Reports
    Termination
    Regulated Product Withdrawals
    FDA Recall Facts
    Cases Studies

    CIVIL ACTIONS
    Seizure
    Injunctions

    CRIMINAL ACTIONS: DEBARMENT, DISQUALIFICATION, AND APPLICATION COMPLIANCE AND INTEGRITY
    Statutory Authority
    Jurisdiction
    Debarment
    Disqualifications
    Applications: Compliance and Validity Issues
    Case Studies

    CASE STUDIES
    Program Implementation
    FDA 483 Forms, Recalls, Corrections, and Market Withdrawals
    Mass Seizure Actions
    Injunction Actions
    Consent Decrees
    Criminal Indictments, Process, and FDA Procedures
    FDA Prosecution
    Debarment
    Case Study Exhibits

    Appendix 1.FD&C Act of 1938
    Chapter III. Prohibited Acts and Penalties
    Seizure
    Chapter V. Drugs and Devices
    Provision of Standards
    General Requirement
    Chapter VIII. Imports and Exports
    Chapter IX. Miscellaneous

    Appendix 2: Drug Law History Synopsis

    Appendix 3: Clinical Investigators
    Clinical Investigator Regulatory Sanctions
    Investigator Responsibilities
    FDA Inspections of Clinical Investigators
    FDA Institutional Review Board Inspections

    Appendix 4: FDA Administrative Procedures Act (FAPA)
    Title 21 (Food and Drugs)CFR 10.1 -10.206381

    Glossary
    Index

    Biography

    Florence R. Parker

    "The only complete, single source available…the book provides an understanding of drug development and manufacturing regulations in the United States and how a company may comply with them."
    --Anticancer Research