TreatiseTreatise

FDA Deskbook: A Compliance and Enforcement Guide

 by James P Ellison, Anne K Walsh
 
 Copyright: 2016

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Product Details

  • ISBN Number: 9781402426476
  • Page Count: 916
  • Number of Volumes: 1
  •  

FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under The Federal Food, Drug, and Cosmetic Act (FDC Act) and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. It explains the legal framework created by the FDC Act and subsequent statutes, regulations, guidance and policies governing the food and drug industry.

Written by attorneys at Hyman, Phelps & McNamara, P.C., the largest dedicated food and drug law firm in the U.S., FDA Deskbook incorporates more than a century of cumulative experience from positions at FDA, the U.S. Department of Justice, the Drug Enforcement Administration, U.S. Attorney’s Offices, and regulated industry. The result is an essential guidebook, which aims to assist industry stakeholders by providing a wide-ranging review of compliance and enforcement under the FDC Act and related laws.

The book first details the ins-and-outs of FDA’s administrative actions (such as warning letters, import alerts, and recalls) and civil and criminal enforcement authorities. Chapters that follow highlight specific issues affecting the cross-section of FDA regulation:

  • drugs, including OTC, prescription, and compounded drugs, and controlled substances
  • medical devices, including in vitro diagnostic devices
  • food and dietary supplements
  • tobacco
  • animal products
  • cosmetics
Importantly, FDA Deskbook contains chapters focused on hot button issues, such as advertising and promotion, fraud and abuse, and good manufacturing practices. The FDA Deskbook proposes best practice tips, including how to deal with FDA inspections, alternatives to conducting internal investigations, and potential defense strategies for use in enforcement proceedings. Its up-to-date coverage helps practitioners to achieve compliance and avoid enforcement action.
  Hyman, Phelps & McNamara, P.C.
  Table of Contents
  Preface
Chapter 1: FDA Administrative Actions
  • § 1:1 : Overview1-3
  • § 1:2 : FDA’s Administrative Authority1-3
    • § 1:2.1 : Generally1-3
    • § 1:2.2 : Jurisdiction Granted to FDA Under the FDC Act1-4
    • § 1:2.3 : FDA’s Shared Authority with Other Agencies1-5
      • [A] : Generally1-5
      • [B] : U.S. Department of Health and Human Services1-5
        • [B][1] : Centers for Medicare and Medicaid Services1-6
      • [C] : U.S. Department of Justice1-6
        • [C][1] : Office of the Assistant Attorney General1-6
        • [C][2] : U.S. Attorneys1-6
        • [C][3] : Drug Enforcement Administration1-6
      • [D] : Federal Trade Commission1-7
      • [E] : U.S. Department of Agriculture1-7
      • [F] : Environmental Protection Agency1-7
      • [G] : U.S. Patent and Trade Office1-7
      • [H] : States1-8
      • [I] : International MOUs1-8
  • § 1:3 : What Triggers an Administrative Action?1-8
    • § 1:3.1 : Generally1-8
    • § 1:3.2 : Types of FDA Action1-9
    • § 1:3.3 : Common Acts Leading to Administrative Actions1-9
      • [A] : Label and Labeling Violations1-9
      • [B] : Product Adulteration and Quality Issues1-10
      • [C] : Acts by Individuals1-10
  • § 1:4 : Types of Administrative Actions1-10
    • § 1:4.1 : Inspections1-10
      • [A] : Generally1-10
      • [B] : 483s1-11
      • [C] : Examples1-11
  • § Table 1-1 : FDA 483 Observations1-12
    • § 1:4.2 : Warning and Untitled Letters1-13
      • [A] : Generally1-13
        • [A][1] : Warning Letters1-13
        • [A][2] : Untitled Letters1-13
      • [B] : Effect on Future FDA Action1-13
        • [B][1] : Interactions with FDA1-13
        • [B][2] : Reputational Harm1-13
      • [C] : Common Categories1-14
    • § 1:4.3 : Recalls1-14
      • [A] : Generally1-14
        • [A][1] : Mandatory Versus Permissive1-14
      • [B] : Effect on Future Acts1-15
        • [B][1] : Interactions with FDA1-15
        • [B][2] : Reputational Harm1-15
      • [C] : Examples1-15
        • [C][1] : Food1-15
        • [C][2] : Drugs: Compounded Drugs1-15
    • § 1:4.4 : Import Detentions1-16
      • [A] : Generally1-16
      • [B] : OASIS System1-16
      • [C] : Effect on Future FDA Action1-16
        • [C][1] : Interactions with FDA1-16
        • [C][2] : Reputational Harm1-16
      • [D] : Examples1-17
    • § 1:4.5 : Administrative Detentions1-17
      • [A] : Generally1-17
        • [A][1] : Food1-17
        • [A][2] : Devices1-17
        • [A][3] : Drugs1-18
      • [B] : Effect on Future FDA Action1-18
      • [C] : Examples1-18
    • § 1:4.6 : Clinical Holds1-18
      • [A] : Generally1-18
      • [B] : Effect on Future FDA Action1-19
      • [C] : Examples1-19
    • § 1:4.7 : Application Integrity Policy1-19
      • [A] : Generally1-19
      • [B] : Effect on Future FDA Action1-19
    • § 1:4.8 : Civil Monetary Penalties1-20
      • [A] : Generally1-20
      • [B] : Effect on Future Acts1-20
      • [C] : Examples1-20
    • § 1:4.9 : Disqualification of Clinical Investigators1-20
      • [A] : Generally1-20
      • [B] : Effect on Future Acts1-21
      • [C] : Examples1-21
    • § 1:4.10 : Debarment1-21
      • [A] : Generally1-21
        • [A][1] : Individuals Versus Corporate Entities1-21
        • [A][2] : Mandatory Versus Permissive1-22
        • [A][3] : Difference from Disqualification1-22
      • [B] : Effect on Future Acts1-22
        • [B][1] : Temporary Versus Permanent1-22
        • [B][2] : Potential for Termination1-22
      • [C] : Examples1-23
    • § 1:4.11 : Publicity1-23
      • [A] : Generally1-23
      • [B] : Effect on Future Acts1-23
  • § 1:5 : Frequency of Administrative Actions1-23
    • § 1:5.1 : Commonly Used Actions1-23
      • [A] : Warning and Untitled Letters1-23
      • [B] : Recalls1-24
      • [C] : Import Detentions1-24
    • § 1:5.2 : Less Common Actions1-24
  • § 1:6 : Facing Administrative Actions1-24
    • § 1:6.1 : What to Do1-24
    • § 1:6.2 : What NOT to Do1-24
    • § 1:6.3 : Avoiding Administrative Action1-25
Chapter 2: FDA Civil Enforcement Actions
  • § 2:1 : Overview2-2
  • § 2:2 : Relevant Government Actors2-2
    • § 2:2.1 : FDA Offices2-2
      • [A] : Office of Regulatory Affairs2-2
      • [B] : Centers’ Office of Compliance2-3
      • [C] : Office of the Chief Counsel2-3
    • § 2:2.2 : U.S. Department of Justice2-4
      • [A] : Civil Division, Consumer Protection Branch2-4
      • [B] : U.S. Attorneys’ Offices2-5
  • § 2:3 : FDA Guidelines for Taking Enforcement Action2-6
    • § 2:3.1 : Regulatory Procedures Manual2-6
    • § 2:3.2 : Compliance Policy Guides2-6
    • § 2:3.3 : Enforcement Discretion2-7
  • § 2:4 : Seizures2-8
    • § 2:4.1 : Overview2-8
    • § 2:4.2 : Legal Authority2-9
    • § 2:4.3 : What Products Can Be Seized?2-10
    • § 2:4.4 : Procedures2-11
      • [A] : Judicial Procedure2-11
      • [B] : Coordination with U.S. Marshals Service2-12
      • [C] : Disposition of Seized Product2-12
    • § 2:4.5 : Challenging a Seizure Action2-13
  • § 2:5 : Injunctions2-14
    • § 2:5.1 : Overview2-14
    • § 2:5.2 : Legal Authority2-14
      • [A] : Overview2-14
      • [B] : Types of Injunctions2-14
        • [B][1] : Temporary Restraining Order2-14
        • [B][2] : Preliminary Injunction2-15
        • [B][3] : Permanent Injunction2-16
      • [C] : Factors Considered by FDA2-16
    • § 2:5.3 : Procedures for Initiating an Injunction Action2-17
      • [A] : Initial Decision2-17
      • [B] : Review by Office of the Chief Counsel2-18
      • [C] : Referral to Department of Justice2-18
    • § 2:5.4 : Defending Against an Injunction Action2-19
    • § 2:5.5 : Consent Decree Provisions2-19
    • § 2:5.6 : Vacating an Injunction2-21
  • § 2:6 : Equitable Remedies: Restitution and Disgorgement2-22
Chapter 3: FDA Criminal Enforcement Actions
  • § 3:1 : Overview3-2
  • § 3:2 : FDC Act Violations3-3
    • § 3:2.1 : Section 301 Prohibited Acts As the Basis for Criminal Violations3-3
      • [A] : Generally3-3
      • [B] : FDA Regulations As the Basis for a Criminal Charge3-3
    • § 3:2.2 : FDC Act Strict Liability Criminal Violations3-4
      • [A] : Regulated Persons and Entities3-4
      • [B] : Responsible Corporate Officers3-4
        • [B][1] : Generally3-4
        • [B][2] : Precedent of Dotterweich and Park3-4
        • [B][3] : Impossibility Defense3-7
    • § 3:2.3 : Felony Violations of the FDC Act3-8
      • [A] : Generally3-8
      • [B] : “Second” Offenses3-8
        • [B][1] : Generally3-8
        • [B][2] : It Is Only a Second Offense If the Government Charges It As Such3-9
      • [C] : Intent to Defraud or Mislead FDA or Consumers3-9
    • § 3:2.4 : Other Title 21 Criminal Violations3-10
    • § 3:2.5 : FDC Act Criminal Penalties3-10
      • [A] : Terms of Imprisonment3-10
      • [B] : Fines3-11
        • [B][1] : Generally3-11
        • [B][2] : Alternative Fine Provision of 18 U.S.C. § 3571(d)3-11
    • § 3:2.6 : Title 21 Statute of Limitations3-12
  • § 3:3 : Title 18 Alternatives to FDC Act Charges3-12
    • § 3:3.1 : Alternative Criminal Statutes3-12
      • [A] : Mail Fraud Act, 18 U.S.C. § 13413-12
      • [B] : Wire Fraud Act, 18 U.S.C. § 13433-12
      • [C] : Criminal Conspiracy Statute, 18 U.S.C. § 3713-13
      • [D] : Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. §§ 1961–19683-13
      • [E] : Health Care Fraud, 18 U.S.C. § 13473-13
      • [F] : False Statements, 18 U.S.C. § 10013-13
      • [G] : Obstruction of Proceedings Before Agencies, 18 U.S.C. § 15053-14
    • § 3:3.2 : Longer Statutory Maximum Terms of Imprisonment3-14
    • § 3:3.3 : Simpler Jury Instructions3-14
    • § 3:3.4 : Statute of Limitations3-14
  • § 3:4 : Prosecutors3-15
    • § 3:4.1 : U.S. Attorneys3-15
    • § 3:4.2 : Consumer Protection Branch3-15
    • § 3:4.3 : FDA Office of the Chief Counsel3-15
  • § 3:5 : Jurisdictional Considerations3-15
    • § 3:5.1 : Where Can an FDA Case Be Brought?3-15
    • § 3:5.2 : Extra-Territorial Application3-16
    • § 3:5.3 : Extradition3-16
  • § 3:6 : Current Trends in Criminal Prosecution: Qui Tams and Parallel Proceedings3-16
    • § 3:6.1 : Generally3-16
    • § 3:6.2 : Off-Label Promotion3-16
  • § 3:7 : Sentencing Guidelines3-17
Chapter 4: Other Authorities Governing FDA-Regulated Entities
  • § 4:1 : Overview4-2
  • § 4:2 : FTC Regulation of Advertising for FDA-Regulated Products4-3
    • § 4:2.1 : Generally4-3
    • § 4:2.2 : Labeling and Advertising of Over-the-Counter Products4-3
      • [A] : Substantiation of Advertising Claims4-3
      • [B] : FTC Investigative and Enforcement Tools4-4
        • [B][1] : Generally4-4
        • [B][2] : Enforcement Actions4-6
    • § 4:2.3 : “Made in the U.S.A.”4-8
    • § 4:2.4 : Overlap with Self-Regulatory Bodies—National Advertising Division, Electronic Retailing Self-Regulation Program, and Children’s Advertising Review Unit4-9
  • § 4:3 : Drug Enforcement Administration4-10
  • § 4:4 : U.S. Department of Agriculture: Plant and Animal Pests, Animal Welfare, and Biotechnology4-12
    • § 4:4.1 : Generally4-12
    • § 4:4.2 : Imports and Permits4-12
    • § 4:4.3 : Animal Welfare4-13
    • § 4:4.4 : Biotechnology4-14
  • § 4:5 : Agencies Administering Certain Health Care and Price Reporting Laws4-15
    • § 4:5.1 : Generally4-15
    • § 4:5.2 : Health Care Fraud and Abuse Laws4-16
    • § 4:5.3 : Government Price Reporting and Government Drug Discount Programs4-16
      • [A] : Medicaid Drug Rebate Program4-16
      • [B] : 340B Drug Discount Program4-18
      • [C] : Medicare Part B and Average Sales Price4-19
      • [D] : Medicare Part D and the Coverage Gap Discount Program4-20
      • [E] : Federal Supply Schedule Contracts4-20
      • [F] : TRICARE Retail Pharmacy Network Program4-22
    • § 4:5.4 : Branded Pharmaceutical Fee and Medical Device Excise Tax4-22
  • § 4:6 : Customs and Border Protection4-23
    • § 4:6.1 : Generally4-23
    • § 4:6.2 : Import Inspections4-24
    • § 4:6.3 : Country of Origin Labeling4-25
  • § 4:7 : State Attorneys General4-26
    • § 4:7.1 : Generally4-26
    • § 4:7.2 : State Food, Drug, and Cosmetic Acts4-27
    • § 4:7.3 : State Consumer Protection Acts and Unfair Competition Laws4-27
    • § 4:7.4 : State False Claims Acts4-28
    • § 4:7.5 : State Slack-Fill Regulations4-29
    • § 4:7.6 : California Proposition 654-30
  • § 4:8 : International Regulatory Bodies4-30
    • § 4:8.1 : World Health Organization/Food and Agriculture Organization, Codex Alimentarius Commission—International Food Standards4-30
    • § 4:8.2 : WHO—Drug Prequalification4-31
  • § 4:9 : Product Liability4-32
Chapter 5: Over-the-Counter Drugs
  • § 5:1 : Introduction5-2
  • § 5:2 : Definition of Over-the-Counter Drugs5-3
  • § 5:3 : OTC Drugs Marketed Under a Monograph5-4
    • § 5:3.1 : Generally5-4
    • § 5:3.2 : OTC Drug Review Process5-5
    • § 5:3.3 : General OTC Drug Labeling Requirements5-6
    • § 5:3.4 : Monograph Requirements5-8
      • [A] : Generally5-8
      • [B] : Active Ingredients5-8
      • [C] : Indications5-10
      • [D] : Dosage Strength and Route of Administration5-10
      • [E] : Warnings and Directions5-11
      • [F] : Formulation Testing5-11
      • [G] : Claims5-11
    • § 5:3.5 : Amending the Monograph5-12
      • [A] : Generally5-12
      • [B] : Citizen Petition5-12
      • [C] : Time and Extent Application5-13
    • § 5:3.6 : OTC Drugs Subject to Unfinished Monographs5-15
  • § 5:4 : FDA Enforcement of Monograph Requirements5-15
    • § 5:4.1 : Generally5-15
    • § 5:4.2 : Inspections5-16
    • § 5:4.3 : Warning Letters5-16
    • § 5:4.4 : Additional Enforcement Actions5-17
  • § 5:5 : Other Paths to Market5-18
    • § 5:5.1 : Generally5-18
    • § 5:5.2 : Direct-to-OTC NDA5-18
    • § 5:5.3 : NDA Deviation5-19
    • § 5:5.4 : NDA Supplement5-19
    • § 5:5.5 : 505(b)(2) NDA5-20
    • § 5:5.6 : Homeopathic Drugs5-20
    • § 5:5.7 : Unapproved Drugs5-21
  • § 5:6 : Entities Responsible for Enforcement5-21
    • § 5:6.1 : FDA5-21
    • § 5:6.2 : U.S. Department of Justice5-22
    • § 5:6.3 : Federal Trade Commission5-22
    • § 5:6.4 : Others5-23
Chapter 6: Drugs: Current Good Manufacturing Practice
  • § 6:1 : Introduction6-2
  • § 6:2 : GMPs Versus cGMPs6-4
  • § 6:3 : FDA’s Risk-Based Approach to Its Statutory Mandate6-5
  • § 6:4 : Scope of cGMPs6-6
    • § 6:4.1 : Introduction6-6
    • § 6:4.2 : Drug Substance Versus Drug Product6-6
    • § 6:4.3 : Investigational Drug Products6-7
    • § 6:4.4 : Excipients6-9
    • § 6:4.5 : For Export Only6-9
  • § 6:5 : General Principles of cGMPs6-10
    • § 6:5.1 : Introduction6-10
    • § 6:5.2 : Quality Management System—The Foundation for Compliance6-10
      • [A] : Introduction6-10
      • [B] : Management Oversight and Review6-11
      • [C] : The Quality Unit6-12
      • [D] : Quality System Development and Implementation6-13
      • [E] : Training and Education6-14
    • § 6:5.3 : Control Over Process6-15
      • [A] : Generally6-15
      • [B] : Process Understanding6-15
      • [C] : In-Process Controls6-16
      • [D] : Process Validation6-16
    • § 6:5.4 : Control Over Materials6-17
      • [A] : Generally6-17
      • [B] : Vendor Controls6-17
      • [C] : Raw Materials6-18
      • [D] : Manufacturing Equipment6-19
      • [E] : Packaging6-19
        • [E][1] : Generally6-19
        • [E][2] : Container and Closure Systems6-19
        • [E][3] : Outer Packaging and Labeling6-20
    • § 6:5.5 : Control Over Product6-20
      • [A] : Generally6-20
      • [B] : Laboratory Testing and Product Release6-20
      • [C] : Shipment and Distribution6-21
      • [D] : Stability Testing6-21
    • § 6:5.6 : Control Over Records6-22
      • [A] : Generally6-22
      • [B] : Recordkeeping6-22
      • [C] : Record Retention6-22
      • [D] : Data Integrity6-23
    • § 6:5.7 : Control Over the Unexpected6-23
      • [A] : Generally6-23
      • [B] : Deviations6-23
      • [C] : Out of Specification Results6-24
      • [D] : Complaints6-24
      • [E] : Investigations6-24
      • [F] : Corrective and Preventive Actions6-25
  • § 6:6 : Putting the “c” in cGMPs6-25
    • § 6:6.1 : Introduction6-25
    • § 6:6.2 : Routine Internal Auditing6-26
    • § 6:6.3 : Review of Procedures and Protocols6-26
    • § 6:6.4 : Maintaining Industry Awareness6-26
      • [A] : Generally6-26
      • [B] : Sources of Best Practices6-26
        • [B][1] : FDA Inspections and Warning Letters6-26
        • [B][2] : FDA Guidance6-26
        • [B][3] : USP and Other Compendia6-27
        • [B][4] : ICH6-27
      • [C] : Keeping Up with Technology6-27
  • § 6:7 : Enforcement and Penalties6-27
    • § 6:7.1 : Pre-Approval and Routine Facility Inspections6-27
    • § 6:7.2 : Impact on Pending or Future Submissions6-28
    • § 6:7.3 : Enforcement Trends6-29
Chapter 7: Drug Compounding
  • § 7:1 : Pharmaceutical Compounding: Well-Recognized and Critically Important7-2
  • § 7:2 : Food and Drug Administration Modernization Act: Federal Courts Divide Over Compounding7-3
  • § 7:3 : New England Compounding Center and 2013 Congressional Action7-5
  • § 7:4 : Passage of the Drug Quality and Security Act, Title I (the Compounding Quality Act)7-7
    • § 7:4.1 : Generally7-7
    • § 7:4.2 : Reinstated Section 503A; Reinvigorated FDA7-8
      • [A] : Generally7-8
      • [B] : FDA’s Guidance Addressing Section 503A7-11
      • [C] : FDA’s Draft Memorandum of Understanding with States on Interstate Shipments of Compounded Products7-13
    • § 7:4.3 : Section 503B: Outsourcing Facilities7-14
      • [A] : Generally7-14
      • [B] : General Section 503B Requirements: Registration, Reporting, cGMP, and FDA Inspections7-15
      • [C] : Outsourcing Facility Restrictions on Compounding7-18
        • [C][1] : Generally7-18
        • [C][2] : Compounding of Products on FDA’s Published Shortage List7-19
        • [C][3] : FDA’s Section 503B Positive List7-19
        • [C][4] : Withdrawn Drugs and the Negative List7-21
        • [C][5] : Prohibition on Wholesaling7-22
    • § 7:4.4 : FDA’s Pharmacy Compounding Advisory Committee7-22
      • [A] : Generally7-22
      • [B] : Committee Membership7-22
  • § 7:5 : Conclusion7-23
Chapter 8: Clinical Trials
  • § 8:1 : Federal Regulation of Clinical Trials8-3
    • § 8:1.1 : History and Overview8-3
    • § 8:1.2 : U.S. Department of Health and Human Services: Policy for Protection of Human Research Subjects (the “Common Rule”)8-4
    • § 8:1.3 : FDA Regulations Regarding the Protection of Human Research Subjects8-4
  • § 8:2 : FDA Regulations for Clinical Studies of Investigational Drugs and Devices8-5
    • § 8:2.1 : Regulated Entities8-5
    • § 8:2.2 : Sponsors8-6
      • [A] : General Responsibilities8-6
      • [B] : Requirements for an Investigational New Drug Application or Investigational Device Exemption8-7
        • [B][1] : INDs8-7
        • [B][2] : IDEs8-9
      • [C] : Selecting Investigators and Monitors8-12
      • [D] : Obtaining Information from Investigators8-12
        • [D][1] : Generally8-12
        • [D][2] : Selecting Monitors8-15
        • [D][3] : Informing Investigators8-16
      • [E] : Review of Ongoing Clinical Investigations8-17
      • [F] : Recordkeeping and Retention8-18
      • [G] : Disposition of Unused Investigational Products8-19
      • [H] : CROs8-20
    • § 8:2.3 : Investigators8-20
      • [A] : General Responsibilities8-20
      • [B] : Control of Investigational Products8-20
      • [C] : Recordkeeping and Retention8-20
      • [D] : Investigator Reporting Requirements8-21
      • [E] : Obtaining Informed Consent8-23
        • [E][1] : Generally8-23
        • [E][2] : Required Elements of Informed Consent8-24
        • [E][3] : Additional Elements8-28
      • [F] : Assurance of IRB Review8-31
    • § 8:2.4 : Institutional Review Boards8-31
      • [A] : Scope8-31
      • [B] : Organization8-32
      • [C] : Functions and Operations8-34
      • [D] : Additional Protections: Vulnerable Populations8-36
    • § 8:2.5 : Clinical Holds and Staged Approval8-40
      • [A] : Generally8-40
      • [B] : Grounds for Imposition of Clinical Hold8-41
      • [C] : Process for Imposition of Clinical Hold8-43
      • [D] : Resumption of Clinical Investigations8-44
    • § 8:2.6 : IND/IDE Termination8-44
    • § 8:2.7 : IND/IDE Withdrawal8-45
  • § 8:3 : Clinical Trial Registration and Results Submission8-46
    • § 8:3.1 : Regulatory History8-46
    • § 8:3.2 : Applicable Clinical Trials8-48
    • § 8:3.3 : Responsible Party8-48
    • § 8:3.4 : Registration8-49
    • § 8:3.5 : Results Reporting of Completed Trials8-50
    • § 8:3.6 : ClinicalTrials.gov Compliance8-52
  • § 8:4 : Potential Conflicts of Interest and Financial Disclosure Regulations8-54
  • § 8:5 : Postmarketing Studies8-57
    • § 8:5.1 : Postmarketing Commitments and Requirements for Drugs8-57
    • § 8:5.2 : Post-Approval Studies for Devices8-59
    • § 8:5.3 : Confirmatory Studies for Accelerated Drug Approvals8-60
    • § 8:5.4 : Postmarketing Requirements for Drugs Approved Under the Animal Rule8-61
    • § 8:5.5 : Pediatric Postmarketing Studies8-62
  • § 8:6 : FDA Inspections and Enforcement Mechanisms8-63
    • § 8:6.1 : Bioresearch Monitoring Program8-63
      • [A] : FDA Inspections of Sponsors and CROs8-63
      • [B] : FDA Inspections of Clinical Investigators8-64
      • [C] : FDA Inspections of Institutional Review Boards8-65
      • [D] : Upon Conclusion of an FDA Inspection8-66
    • § 8:6.2 : FDA Enforcement Under BIMO8-67
      • [A] : Issuing Untitled, Warning, and Restrictions Letters8-67
      • [B] : Investigator Disqualification8-68
      • [C] : Debarment8-70
    • § 8:6.3 : FDA Inspections and Enforcement8-71
      • [A] : Clinical Investigators8-71
      • [B] : Sponsors8-71
      • [C] : IRBs8-72
  • Appendix 8A : Statement of Investigator, Form, FDA 1572App. 8A-1
Chapter 9: Quality System Regulation
  • § 9:1 : Overview9-2
  • § 9:2 : General Provisions9-3
    • § 9:2.1 : Overview9-3
    • § 9:2.2 : Scope9-3
      • [A] : History and Authority9-3
      • [B] : Applicability9-4
        • [B][1] : Generally9-4
        • [B][2] : Foreign Manufacturers9-5
      • [C] : Exemptions9-5
    • § 9:2.3 : Definitions9-5
  • § 9:3 : Quality System Requirement9-7
    • § 9:3.1 : Generally9-7
    • § 9:3.2 : Quality System9-7
    • § 9:3.3 : Management Responsibility9-8
      • [A] : Management with Executive Responsibility9-8
      • [B] : Quality Policy9-8
      • [C] : Organization and Resources9-9
        • [C][1] : Generally9-9
        • [C][2] : Organization9-9
        • [C][3] : Resources9-9
      • [D] : Responsibility and Authority9-9
      • [E] : Management Representative9-10
      • [F] : Management Review9-10
      • [G] : Quality Planning9-11
      • [H] : Quality System Procedures9-12
    • § 9:3.4 : Quality Audits9-12
    • § 9:3.5 : Personnel9-14
      • [A] : Generally9-14
      • [B] : Training9-14
  • § 9:4 : Design Controls9-15
    • § 9:4.1 : Design Control Requirements9-15
      • [A] : Generally9-15
      • [B] : Applicability9-15
      • [C] : Design and Development Planning9-16
      • [D] : Design Inputs and Outputs9-16
      • [E] : Design Review9-17
      • [F] : Design Verification9-18
      • [G] : Design Validation9-18
      • [H] : Design Transfer9-18
      • [I] : Design Changes9-19
      • [J] : Design History File, Device Master Record, and Device History Record9-19
  • § 9:5 : Purchasing Controls9-20
  • § 9:6 : Production and Process Controls9-21
    • § 9:6.1 : Production and Process Control Requirements9-21
    • § 9:6.2 : Inspection, Measuring, and Test Equipment9-22
    • § 9:6.3 : Process Validation9-22
  • § 9:7 : Control of Devices9-23
    • § 9:7.1 : Receiving, In-Process, and Finished Device Acceptance9-23
    • § 9:7.2 : Acceptance Status and Identification9-23
    • § 9:7.3 : Nonconforming Product9-24
  • § 9:8 : Corrective and Preventive Action9-25
  • § 9:9 : Labeling and Traceability9-25
    • § 9:9.1 : Labeling Control9-25
    • § 9:9.2 : Traceability9-26
  • § 9:10 : Records9-26
    • § 9:10.1 : General Requirements9-26
    • § 9:10.2 : Document Controls and Good Documentation Practices9-27
  • § 9:11 : Complaint Handling9-27
  • § 9:12 : Servicing9-28
Chapter 10: Devices: Recalls
  • § 10:1 : Overview10-2
  • § 10:2 : General Provisions10-2
    • § 10:2.1 : Scope10-2
    • § 10:2.2 : Definitions10-3
      • [A] : Correction10-3
      • [B] : Removal10-3
      • [C] : Market Withdrawal10-3
      • [D] : Risk to Health10-3
      • [E] : Routine Servicing10-4
      • [F] : Stock Recovery10-4
    • § 10:2.3 : Types of Recalls10-4
      • [A] : Firm-Initiated Recall10-4
      • [B] : FDA-Requested Recall10-5
      • [C] : FDA Mandatory Recall Authority10-6
  • § 10:3 : Identification and Classification10-6
    • § 10:3.1 : Identifying Potential Recalls10-6
    • § 10:3.2 : Health Risk Assessment/Health Hazard Evaluation10-7
    • § 10:3.3 : Classification10-8
  • § 10:4 : Recall Execution10-8
    • § 10:4.1 : Strategy10-8
      • [A] : Generally10-8
      • [B] : Elements of a Recall Strategy10-8
        • [B][1] : Depth of Recall10-8
        • [B][2] : Public Warning10-9
        • [B][3] : Effectiveness Checks10-9
    • § 10:4.2 : Communication10-9
      • [A] : Consignee Communication10-9
      • [B] : Public Notification10-10
    • § 10:4.3 : Recall Status Reports10-10
    • § 10:4.4 : Termination10-11
  • § 10:5 : Reporting to FDA10-11
    • § 10:5.1 : Scope10-11
      • [A] : Applicability10-11
      • [B] : Exemptions10-12
    • § 10:5.2 : Initial Reports10-14
    • § 10:5.3 : Status Reports10-16
  • § 10:6 : Recordkeeping10-16
    • § 10:6.1 : Recall Records10-16
    • § 10:6.2 : Access to Recall Records10-16
  • Appendix 10A : Form Template HHEApp. 10A-1
  • Appendix 10B : Recall Notification LetterApp. 10B-1
Chapter 11: Devices: Medical Device Reports
  • § 11:1 : Overview11-2
  • § 11:2 : General Provisions11-2
    • § 11:2.1 : Scope11-2
      • [A] : Authority11-2
      • [B] : Applicability of MDR Requirements to Regulated Industries11-3
        • [B][1] : Manufacturer11-3
        • [B][2] : Importer11-4
        • [B][3] : User Facility11-4
      • [C] : Exemptions, Variances, and Alternative Reporting11-5
    • § 11:2.2 : General Provisions11-6
      • [A] : Public Disclosure of MDRs11-6
      • [B] : MDRs Not an Admission11-7
  • § 11:3 : Reportable Events11-7
    • § 11:3.1 : Death or Serious Injury11-8
    • § 11:3.2 : Malfunction11-9
    • § 11:3.3 : Foreign Events11-11
  • § 11:4 : Procedures and Record11-12
    • § 11:4.1 : MDR Procedure Requirements11-12
      • [A] : General Requirements11-12
      • [B] : Identification of Reportable Events11-13
        • [B][1] : Device-Related Complaint Review11-13
        • [B][2] : Receipt of Voluntary Reports11-13
    • § 11:4.2 : MDR Files11-14
  • § 11:5 : Reporting11-14
    • § 11:5.1 : How to Report11-14
    • § 11:5.2 : MDR Required Information11-16
      • [A] : General Requirements11-16
      • [B] : Reporting Codes11-16
      • [C] : Multiple Devices11-17
  • § 11:6 : Manufacturer Requirements11-17
    • § 11:6.1 : Reporting Requirements11-17
      • [A] : Thirty-Day Reports11-17
      • [B] : Five-Day Reports11-17
    • § 11:6.2 : Supplemental Reports11-18
    • § 11:6.3 : Foreign Manufacturers11-18
  • § 11:7 : Importer Requirements11-18
  • § 11:8 : User Facility Requirements11-19
    • § 11:8.1 : Individual Reports11-19
    • § 11:8.2 : Annual Reports11-19
  • § 11:9 : Distributor Requirements11-19
Chapter 12: Devices: In Vitro Diagnostic Devices
  • § 12:1 : Overview12-2
  • § 12:2 : Definition of In Vitro Diagnostics (IVDs)12-2
    • § 12:2.1 : Statutory Definition: FDC Act § 201(h)12-2
    • § 12:2.2 : Regulation: 21 C.F.R. § 809.312-3
    • § 12:2.3 : Courts Broadly Interpret “Diagnose”12-3
  • § 12:3 : Overlap with Other Device Regulatory Provisions12-6
    • § 12:3.1 : Office of In Vitro Diagnostics and Radiological Health12-6
    • § 12:3.2 : Classification Scheme12-6
    • § 12:3.3 : Importance of Intended Use12-7
    • § 12:3.4 : Premarket Review12-7
    • § 12:3.5 : Quality System Regulation12-8
    • § 12:3.6 : Recalls, Corrections and Removals12-9
    • § 12:3.7 : Registration and Listing12-9
    • § 12:3.8 : Medical Device Reporting12-9
    • § 12:3.9 : Labeling/Promotion12-10
  • § 12:4 : Laboratory-Developed Tests12-10
    • § 12:4.1 : Generally12-10
    • § 12:4.2 : Clinical Laboratory Improvement Amendments of 198812-11
    • § 12:4.3 : FDA Asserts Authority Over LDTs12-11
    • § 12:4.4 : 1997 Analyte Specific Reagents Regulation12-11
    • § 12:4.5 : Warning Letters12-12
    • § 12:4.6 : Active FDA Risk-Based Approach Regulation of LDTs12-14
    • § 12:4.7 : “It Has Come to Our Attention” Letters12-15
    • § 12:4.8 : FDA Draft Guidance on the Active Regulation of LDTs12-18
    • § 12:4.9 : LDT Draft Guidances: Support and Opposition12-21
  • § 12:5 : Analyte Specific Reagents12-22
    • § 12:5.1 : Definition12-22
    • § 12:5.2 : ASR Distribution Limitations12-24
    • § 12:5.3 : September 2007 FDA Guidance Narrows Scope of ASRs12-24
  • § 12:6 : Research Use Only/Investigational Use Only Products12-25
    • § 12:6.1 : Research Use Only Products12-25
    • § 12:6.2 : Investigational Use Only Products12-28
  • § 12:7 : Forensic Use12-29
    • § 12:7.1 : For Law Enforcement Purposes12-29
    • § 12:7.2 : Warning Letters12-30
  • § 12:8 : General Purpose Reagents12-32
Chapter 13: Food and Dietary Supplements
  • § 13:1 : Overview13-3
  • § 13:2 : Foods13-4
    • § 13:2.1 : Generally13-4
    • § 13:2.2 : Dietary Supplements13-4
    • § 13:2.3 : Meat, Poultry, and Egg Products13-5
  • § 13:3 : Food and Drug Administration13-7
    • § 13:3.1 : Generally13-7
    • § 13:3.2 : Adulteration13-9
      • [A] : Generally13-9
      • [B] : Unintended Components/Contaminants13-9
        • [B][1] : Poisonous or Deleterious Substances13-9
        • [B][2] : Current Good Manufacturing Practice and Hazard Analysis and Critical Control Points13-11
          • [B][2][a] : Generally13-11
          • [B][2][b] : Low-Acid Canned Foods and Acidified Foods cGMPs13-12
          • [B][2][c] : Infant Formula cGMPs13-13
          • [B][2][d] : Hazard Analysis and Critical Control Points for Juices, and for Fish and Fishery Products13-14
          • [B][2][e] : Dietary Supplement cGMPs13-15
        • [B][3] : Food Safety Modernization Act13-15
      • [C] : Substances Intentionally Added to Food13-18
        • [C][1] : Generally13-18
        • [C][2] : Food Additives13-19
          • [C][2][a] : Generally13-19
          • [C][2][b] : Food Contact Substances13-20
        • [C][3] : Color Additives13-21
        • [C][4] : GRAS Uses of Substances13-21
        • [C][5] : Pesticides13-22
        • [C][6] : Dietary Ingredients13-23
    • § 13:3.3 : Misbranding13-24
      • [A] : Generally13-24
      • [B] : Mandatory Label Requirements13-24
      • [C] : Health Claims13-26
      • [D] : Nutrient Content Claims13-28
      • [E] : Structure/Function Claims13-28
      • [F] : Menu Labeling13-29
      • [G] : Other Labeling Claims13-30
    • § 13:3.4 : Miscellaneous Provisions13-30
      • [A] : Facility Registration13-30
      • [B] : Distribution and Recordkeeping13-31
      • [C] : Reportable Food Registry13-32
      • [D] : Adverse Event Reporting13-32
  • § 13:4 : FDA Enforcement Powers Related to Foods13-33
    • § 13:4.1 : Inspections13-33
    • § 13:4.2 : Recalls13-34
      • [A] : “Voluntary” Recalls13-34
      • [B] : Mandatory Recalls13-35
    • § 13:4.3 : Warning and Other Letters13-36
      • [A] : Warning Letters13-36
      • [B] : Cyber Letters13-37
      • [C] : Courtesy Letters13-37
    • § 13:4.4 : Suspension of Facility Registration13-38
    • § 13:4.5 : Administrative Detention13-38
    • § 13:4.6 : Seizure13-40
    • § 13:4.7 : Injunction13-40
    • § 13:4.8 : Criminal Actions13-41
      • [A] : Strict Liability13-41
      • [B] : Felonies13-42
    • § 13:4.9 : Regulatory Compliance Guaranties13-43
    • § 13:4.10 : Enforcement Actions Related to Import of Foods13-45
      • [A] : Administrative Holds, Detentions, and Refusals13-45
      • [B] : Debarment13-46
  • § 13:5 : Food Safety Inspection Service13-47
    • § 13:5.1 : Generally13-47
    • § 13:5.2 : Adulteration13-48
      • [A] : Generally13-48
      • [B] : HACCP13-48
      • [C] : Sanitary, Processing and Facility Requirements for Egg Products Processing13-50
      • [D] : Ingredients13-51
    • § 13:5.3 : Misbranding13-52
  • § 13:6 : FSIS Enforcement13-54
    • § 13:6.1 : Generally13-54
    • § 13:6.2 : Inspection-Related Enforcement Powers of FSIS13-54
    • § 13:6.3 : Actions Against Products13-55
      • [A] : Generally13-55
      • [B] : Product Recalls13-55
    • § 13:6.4 : Administrative Actions13-56
      • [A] : Rules of Practice13-56
      • [B] : Regulatory Control Actions13-56
      • [C] : Suspension of Inspection13-57
      • [D] : Withholding Action13-57
      • [E] : Notices of Intended Enforcement Action13-57
      • [F] : Appeals13-58
      • [G] : Withdrawal of Inspection13-58
    • § 13:6.5 : Civil and Criminal Actions13-58
    • § 13:6.6 : Notice of Warning13-59
    • § 13:6.7 : Imports13-59
  • § 13:7 : Other Federal Agencies Regulating Food13-60
    • § 13:7.1 : Generally13-60
    • § 13:7.2 : Alcohol and Tobacco Tax and Trade Bureau13-60
  • § 13:8 : States13-62
    • § 13:8.1 : Food Other Than Meat and Poultry13-62
      • [A] : Generally13-62
      • [B] : Federal-State Cooperative Programs13-63
    • § 13:8.2 : Meat and Poultry13-64
  • § 13:9 : Private Actions13-65
Chapter 14: Tobacco Products
  • § 14:1 : Overview14-2
  • § 14:2 : Scope of Authority14-2
  • § 14:3 : Prohibited Adulteration and Misbranding14-4
  • § 14:4 : Tobacco Product Scientific Advisory Committee14-5
  • § 14:5 : Establishment of Tobacco Product Standards14-6
  • § 14:6 : Premarket Authorities14-7
    • § 14:6.1 : Generally14-7
    • § 14:6.2 : Premarket Notifications14-7
    • § 14:6.3 : Premarket Applications14-9
      • [A] : Generally14-9
      • [B] : Approval Orders and Denials14-9
      • [C] : Withdrawal and Suspension of an Approved Product14-10
    • § 14:6.4 : A Special Category: Modified Risk Tobacco Products14-11
  • § 14:7 : Reporting Requirements14-11
    • § 14:7.1 : Registration and Listing14-11
    • § 14:7.2 : Health Information and Health Effects14-12
    • § 14:7.3 : “Track-and-Trace” Requirements14-12
  • § 14:8 : Restrictions on the Sale, Distribution, Advertising, and Promotion of Tobacco Products14-13
  • § 14:9 : Constitutional Challenges to the Tobacco Control Act14-16
  • § 14:10 : Enforcement14-17
    • § 14:10.1 : State and Federal-State Enforcement Efforts14-17
    • § 14:10.2 : State Enforcement Efforts: Electronic Cigarettes14-19
    • § 14:10.3 : FDA Enforcement Efforts14-20
    • § 14:10.4 : Warning Letters14-21
    • § 14:10.5 : Civil Money Penalty Actions14-21
    • § 14:10.6 : No Tobacco Sales Order14-22
  • § 14:11 : The Proposed Deeming Rule14-23
Chapter 15: Animal Products
  • § 15:1 : Overview15-2
  • § 15:2 : Authority and Organization15-3
  • § 15:3 : New Animal Drugs15-4
    • § 15:3.1 : Premarket Authorities15-4
    • § 15:3.2 : Investigational Use15-5
    • § 15:3.3 : Product Review and Approval15-6
    • § 15:3.4 : Postmarket Authorities15-7
      • [A] : Generally15-7
      • [B] : Reporting Requirements15-7
      • [C] : Changes to an Application15-8
      • [D] : Withdrawal15-9
    • § 15:3.5 : Medicated Animal Feed15-9
  • § 15:4 : Animal Food and Animal Feed15-10
    • § 15:4.1 : Generally15-10
    • § 15:4.2 : Premarket Authorities15-11
    • § 15:4.3 : Food Additive Petitions15-12
    • § 15:4.4 : GRAS Ingredients15-13
    • § 15:4.5 : AAFCO Feed Ingredient Definitions15-14
  • § 15:5 : Animal Supplements15-15
    • § 15:5.1 : Regulatory Framework15-15
    • § 15:5.2 : National Animal Supplement Council15-16
  • § 15:6 : Other Product Types15-17
    • § 15:6.1 : Veterinary Devices15-17
    • § 15:6.2 : Veterinary Biologics15-17
    • § 15:6.3 : Pesticides15-19
    • § 15:6.4 : Combination Products15-20
    • § 15:6.5 : Genetically Engineered Animals15-21
    • § 15:6.6 : Animal Stem-Cell-Based Products15-22
  • § 15:7 : Animal Drug Compounding15-22
    • § 15:7.1 : Generally15-22
    • § 15:7.2 : FDA’s Draft Guidance Document Addressing Veterinary Drugs Compounded from Bulk Substances15-23
    • § 15:7.3 : FDA’s Proposed Changes to Its Regulation of Animal Drug Compounding15-25
      • [A] : FDA’s Draft Guidance Generally15-25
      • [B] : Summary of Proposed Limitations: Draft Animal Compounding Guidance15-26
        • [B][1] : State-Licensed Compounding Pharmacies15-26
        • [B][2] : State-Licensed Veterinarians15-27
        • [B][3] : Outsourcing Facilities15-28
  • § 15:8 : Other Use Outside the Scope of an Approval15-29
    • § 15:8.1 : Generally15-29
    • § 15:8.2 : Off-Label and Extra-Label Use15-30
    • § 15:8.3 : Indexing and Conditional Approval15-31
    • § 15:8.4 : Regulatory Enforcement Discretion15-32
  • § 15:9 : Coordination with Other Government Actors15-33
    • § 15:9.1 : Other FDA Centers15-33
    • § 15:9.2 : U.S. Department of Agriculture—Center for Veterinary Biologics15-34
    • § 15:9.3 : EPA15-34
    • § 15:9.4 : State Regulators15-34
  • § 15:10 : Enforcement15-34
    • § 15:10.1 : Generally15-34
    • § 15:10.2 : Court Action15-35
    • § 15:10.3 : Warning Letters15-35
Chapter 16: Cosmetics
  • § 16:1 : Overview16-2
  • § 16:2 : Definition of “Cosmetic”16-3
  • § 16:3 : Statutory and Regulatory Framework16-4
  • § 16:4 : Adulteration16-4
    • § 16:4.1 : Adulteration and Cosmetic Ingredients16-5
      • [A] : FDA Regulation of Cosmetic Ingredients16-5
      • [B] : Industry Self-Regulation of Cosmetic Ingredients16-6
    • § 16:4.2 : Color Additives16-7
      • [A] : Color Additives Generally16-7
      • [B] : The Delaney Clause16-8
      • [C] : Coal-Tar Hair Dye Exemption16-9
      • [D] : Tattoos16-9
    • § 16:4.3 : Adulteration and Cosmetic Manufacturing16-10
      • [A] : Cosmetic GMP Guidance Documents16-10
      • [B] : Voluntary Cosmetic Registration Program16-11
  • § 16:5 : Misbranding16-12
    • § 16:5.1 : Mandatory Label Statements16-13
      • [A] : Label Versus Labeling16-13
      • [B] : Requirements Under the Fair Packaging and Labeling Act16-14
      • [C] : Warnings16-16
    • § 16:5.2 : Claims16-16
      • [A] : Cosmetic Claims Versus Drug Claims16-16
      • [B] : Other Claims16-18
      • [C] : Claim Substantiation16-19
  • § 16:6 : FDA Enforcement of Cosmetic Requirements16-20
    • § 16:6.1 : Inspections16-20
    • § 16:6.2 : Warning Letters16-21
    • § 16:6.3 : Additional Enforcement Actions16-22
  • § 16:7 : Other Sources of Legal and Regulatory Challenges16-22
Chapter 17: Controlled Substances
  • § 17:1 : Overview17-2
  • § 17:2 : Scope of Enforcement17-2
    • § 17:2.1 : Classification of Controlled Substances17-3
    • § 17:2.2 : Facility and Practitioner Registration17-3
    • § 17:2.3 : Security for Storage and Handling17-4
    • § 17:2.4 : Complete and Accurate Records17-5
    • § 17:2.5 : Form, Manner, and Content of Prescriptions17-6
    • § 17:2.6 : Transaction and Ad Hoc Reporting17-7
  • § 17:3 : Type of Enforcement17-8
    • § 17:3.1 : Administrative Enforcement Actions17-8
      • [A] : Verbal Warning17-9
      • [B] : Letter of Admonition17-9
      • [C] : Voluntary Surrender17-9
      • [D] : Informal Administrative Hearing17-10
      • [E] : Order to Show Cause17-10
      • [F] : Immediate Suspension17-11
    • § 17:3.2 : Civil Penalties17-12
    • § 17:3.3 : Criminal and Forfeiture Enforcement Actions17-13
  • § 17:4 : Examples of Enforcement Cases17-14
    • § 17:4.1 : Administrative Revocation of Prescriber and Practitioner Registration17-14
    • § 17:4.2 : Failure to Maintain Complete and Accurate Records17-15
    • § 17:4.3 : Dispensing for Non-Legitimate Purpose17-17
    • § 17:4.4 : Failure to Report Suspicious Orders17-19
    • § 17:4.5 : Cases Involving List I Chemicals17-22
    • § 17:4.6 : Enforcement Action Against Non-Registrants17-24
  • § 17:5 : Conclusion17-25
Chapter 18: Promotion and Marketing of Prescription Drugs, Biologics, and Devices
  • § 18:1 : Overview18-2
  • § 18:2 : Legal Overview18-3
    • § 18:2.1 : Prohibited Acts18-3
      • [A] : Generally18-3
      • [B] : Misbranding18-4
      • [C] : Unapproved New Drug18-4
    • § 18:2.2 : Classes of Promotional Materials18-5
      • [A] : Generally18-5
      • [B] : Promotional Labeling18-5
      • [C] : Advertising18-6
  • § 18:3 : Promotional Requirements18-6
    • § 18:3.1 : Generally18-6
    • § 18:3.2 : Substantiation of Claims18-7
      • [A] : Generally18-7
      • [B] : Comparative Claims18-8
      • [C] : Implied Claims18-8
      • [D] : Pharmacoeconomic Claims18-9
    • § 18:3.3 : Fair Balance and Contextualizing Information18-10
    • § 18:3.4 : Submission of Promotional Materials18-11
  • § 18:4 : Types of Promotion18-12
    • § 18:4.1 : Pre-Approval Promotion18-12
    • § 18:4.2 : Post-Approval Promotion18-13
      • [A] : Generally18-13
      • [B] : Advertising to Consumers—Specific Requirements18-14
      • [C] : Reminder Materials18-16
    • § 18:4.3 : Excluded Types of Communications18-16
      • [A] : Generally18-16
      • [B] : Continuing Medical Education (CME) Programs18-17
      • [C] : Scientific Exchange18-17
      • [D] : Disease Awareness Communications18-21
  • § 18:5 : Internet and Social Media18-22
    • § 18:5.1 : Generally18-22
    • § 18:5.2 : Postmarketing Submission of Promotional Materials18-23
    • § 18:5.3 : Character and Space Limitations18-24
    • § 18:5.4 : Correcting Third-Party Misinformation18-24
    • § 18:5.5 : Additional Issues Related to Internet and Social Media18-25
  • § 18:6 : Devices18-25
    • § 18:6.1 : Generally18-25
    • § 18:6.2 : Device Labeling18-26
    • § 18:6.3 : Device Advertising18-27
    • § 18:6.4 : Device Substantiation18-28
    • § 18:6.5 : Unapproved Device Promotion18-29
    • § 18:6.6 : Applicable FDA Guidance Documents18-29
  • Appendix 18A : FDA Organizations and Areas of ResponsibilitiesApp. 18A-1
Chapter 19: Health Care Fraud and Abuse Laws
  • § 19:1 : Overview19-3
  • § 19:2 : Federal Health Care Program Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b))19-4
    • § 19:2.1 : Prohibited Conduct19-4
    • § 19:2.2 : Statutory Exemptions19-6
    • § 19:2.3 : AKS Safe Harbor Regulations19-7
      • [A] : General Considerations19-7
      • [B] : Discounts (42 C.F.R. § 1001.952(h))19-8
      • [C] : Personal Services and Management Contracts (42 C.F.R. § 1001.952(d))19-12
      • [D] : Group Purchasing Organizations (42 C.F.R. § 1001.952(j))19-13
      • [E] : Employees (42 C.F.R. § 1001.952(i))19-13
      • [F] : Price Reductions to Eligible Managed Care Organizations (42 C.F.R. § 1001.952(t))19-14
      • [G] : Other Safe Harbors19-15
    • § 19:2.4 : OIG Guidance on Compliance with the AKS19-15
      • [A] : Special Fraud Alert19-15
      • [B] : OIG Compliance Program Guidance19-16
      • [C] : OIG Advisory Opinions19-16
  • § 19:3 : Other Anti-Kickback and Related Laws and Industry Codes19-17
    • § 19:3.1 : Civil Monetary Penalty for Remuneration to Medicare or Medicaid Beneficiary (42 U.S.C. § 1320a-7a(a)(5), (i)(6))19-17
    • § 19:3.2 : Anti-Kickback Act of 1986 (41 U.S.C. § 8701–8707)19-18
    • § 19:3.3 : Stark Anti-Referral Law (42 U.S.C. § 1395nn)19-19
    • § 19:3.4 : State Anti-Kickback Laws19-19
    • § 19:3.5 : Federal Payment Transparency Reporting Law (Physician Payments Sunshine Act)19-20
    • § 19:3.6 : State Gift Prohibitions and Transparency Reporting Laws19-22
    • § 19:3.7 : State Compliance Program Requirements19-22
    • § 19:3.8 : State Consumer Protection Laws19-22
    • § 19:3.9 : State Laws Regulating Professional Conduct of Physicians and Pharmacists19-23
    • § 19:3.10 : PhRMA Code19-23
    • § 19:3.11 : AdvaMed Code19-24
    • § 19:3.12 : Health Care Fraud (18 U.S.C. § 1347)19-26
  • § 19:4 : Enforcement Risk Areas for Drug and Device Companies Under the AKS19-27
    • § 19:4.1 : Free Goods, Services, and Other Benefits19-27
      • [A] : Free Goods19-27
        • [A][1] : Generally19-27
        • [A][2] : OIG Guidance19-27
        • [A][3] : Enforcement19-28
          • [A][3][a] : Free Product19-28
          • [A][3][b] : Gifts and Travel19-29
      • [B] : Reimbursement Assistance19-30
      • [C] : Patient Assistance Programs19-31
        • [C][1] : OIG Guidance19-31
      • [D] : Coupons19-32
        • [D][1] : Generally19-32
        • [D][2] : OIG Position19-32
        • [D][3] : Enforcement19-33
      • [E] : Practice Tips19-34
    • § 19:4.2 : Bundled Discounts and “Swapping”19-35
      • [A] : Generally19-35
      • [B] : OIG Guidance19-35
      • [C] : Enforcement19-36
      • [D] : Practice Tips19-37
    • § 19:4.3 : Consulting Fees19-37
      • [A] : Generally19-37
      • [B] : OIG Guidance19-38
      • [C] : Enforcement19-38
      • [D] : Practice Tips19-39
    • § 19:4.4 : Grants19-40
      • [A] : Generally19-40
      • [B] : OIG Guidance19-40
      • [C] : Enforcement19-40
      • [D] : Practice Tips19-41
        • [D][1] : Grants for Research19-41
        • [D][2] : Grants to Support Independent Scientific or Educational Programs19-41
    • § 19:4.5 : Postmarketing Studies and Registries19-42
      • [A] : OIG Guidance19-42
      • [B] : Enforcement19-43
      • [C] : Practice Tips19-43
        • [C][1] : Postmarketing Studies19-43
        • [C][2] : Registries19-44
    • § 19:4.6 : Payments to Pharmacies19-44
      • [A] : Generally19-44
      • [B] : OIG Guidance19-45
      • [C] : Enforcement19-45
      • [D] : Practice Tips19-45
  • § 19:5 : Federal False Claims Act (31 U.S.C. § 3729–3733)19-46
    • § 19:5.1 : Generally19-46
    • § 19:5.2 : FCA Prohibitions19-46
    • § 19:5.3 : FCA Liability for Kickbacks19-48
    • § 19:5.4 : Liability for Providing Reimbursement Advice19-48
      • [A] : Generally19-48
      • [B] : OIG Guidance19-48
      • [C] : Enforcement19-49
    • § 19:5.5 : Inflation of Reported Drug Prices19-49
    • § 19:5.6 : Reporting of Prices to CMS19-50
      • [A] : Generally19-50
      • [B] : OIG Guidance19-51
      • [C] : Enforcement19-51
    • § 19:5.7 : Off-Label Promotion of Drugs As Basis for FCA Liability19-52
    • § 19:5.8 : Other FDC Act Violations As Basis for FCA Allegations19-53
Chapter 20: Internal Investigations
  • § 20:1 : Overview20-3
  • § 20:2 : Triggers of an Investigation20-5
    • § 20:2.1 : Laying the Foundation20-5
    • § 20:2.2 : Sources of Information about Investigable Situations20-5
      • [A] : Employees20-5
      • [B] : Victims20-6
      • [C] : Whistleblowers20-6
      • [D] : Government Agencies20-6
      • [E] : Other Third-Party Sources20-7
      • [F] : Compliance Hotlines20-7
    • § 20:2.3 : Documenting the Complaint20-8
    • § 20:2.4 : Public Statements20-9
  • § 20:3 : Initiating an Investigation20-9
    • § 20:3.1 : Generally20-9
    • § 20:3.2 : Timeliness20-11
    • § 20:3.3 : Prevention of Retaliatory Claims20-11
    • § 20:3.4 : Stopping Ongoing Conduct20-12
  • § 20:4 : Scope of the Investigation20-12
    • § 20:4.1 : Identifying Goals20-12
    • § 20:4.2 : Creating a Plan20-12
  • § 20:5 : Staffing the Investigation20-13
    • § 20:5.1 : Generally20-13
    • § 20:5.2 : Legal Counsel20-13
      • [A] : Generally20-13
      • [B] : Internal Versus External Counsel20-14
      • [C] : Separate Counsel for Employees and Others20-15
      • [D] : Privilege Issues20-16
    • § 20:5.3 : Investigations by Non-Legal Company Personnel20-17
    • § 20:5.4 : Use of Outside Experts20-17
    • § 20:5.5 : Oversight of the Investigation20-17
  • § 20:6 : Conducting the Investigation20-18
    • § 20:6.1 : Generally20-18
    • § 20:6.2 : Documents20-18
      • [A] : Document Preservation20-18
        • [A][1] : Custodians20-18
        • [A][2] : Information Technology20-19
        • [A][3] : Litigation Hold Notices20-19
      • [B] : Document Collection20-19
        • [B][1] : Generally20-19
        • [B][2] : Custodian Interviews20-19
        • [B][3] : Paper Documents20-20
        • [B][4] : Electronic Files20-20
      • [C] : Role of IT Experts20-21
      • [D] : Document Management and Review20-21
    • § 20:6.3 : Interviews20-22
      • [A] : Generally20-22
      • [B] : Preparation20-23
        • [B][1] : Generally20-23
        • [B][2] : Selection of Interviewees20-23
        • [B][3] : Sequence of Interviews20-23
        • [B][4] : Scheduling Interviews20-24
        • [B][5] : Interview Outline and Questions20-25
        • [B][6] : Providing Documents to Interviewees20-25
      • [C] : Conducting Interviews20-25
        • [C][1] : Interviewers20-25
        • [C][2] : Tone20-26
        • [C][3] : Upjohn Warnings and Other Preliminary Statements20-26
        • [C][4] : Asking Questions20-27
        • [C][5] : Concluding Instructions20-28
      • [D] : Interviews of Third Parties20-28
      • [E] : Other Investigative Techniques20-29
  • § 20:7 : Investigation Records20-29
    • § 20:7.1 : Generally20-29
    • § 20:7.2 : Document Summaries20-29
    • § 20:7.3 : Interview Reports20-29
    • § 20:7.4 : Reports of Findings20-30
      • [A] : Interim Updates20-30
      • [B] : Final Report20-30
  • § 20:8 : Remedial Actions20-31
    • § 20:8.1 : Stopping Violative Conduct20-31
    • § 20:8.2 : Discipline20-32
      • [A] : Generally20-32
      • [B] : Verbal Warnings20-32
      • [C] : Written Warnings20-32
      • [D] : Training20-32
      • [E] : Termination20-33
      • [F] : Severance Agreements20-33
    • § 20:8.3 : Adopting New Policies and Controls20-33
    • § 20:8.4 : Self-Disclosure20-34
  • § 20:9 : Special Considerations for International Investigations20-36
  • Appendix 20A : Sample Upjohn WarningApp. 20A-1
Chapter 21: FDA Inspections
  • § 21:1 : Role of Inspections21-2
    • § 21:1.1 : Overview21-2
    • § 21:1.2 : FDA’s Reasons to Inspect21-3
    • § 21:1.3 : Potential Outcomes of Inspections21-4
  • § 21:2 : FDA Authority to Access Facilities and Records and Conduct Interviews21-4
    • § 21:2.1 : Generally21-4
    • § 21:2.2 : Authority with Respect to Specific Facilities21-6
      • [A] : Food and Dietary Supplement Facilities21-6
      • [B] : Drug and Biologic Facilities21-7
      • [C] : Device Facilities21-8
      • [D] : Cosmetic Facilities21-9
      • [E] : Foreign Facilities21-9
      • [F] : Pharmacies21-9
    • § 21:2.3 : Who Conducts an Inspection?21-10
    • § 21:2.4 : FDA Credentials and Forms21-11
    • § 21:2.5 : Refusal or Delay, the Definition and Consequences21-11
    • § 21:2.6 : Involvement of State and Local Officials in Inspections21-12
  • § 21:3 : Preparing for an Inspection21-13
    • § 21:3.1 : Generally21-13
    • § 21:3.2 : Policies21-13
    • § 21:3.3 : Personnel21-14
    • § 21:3.4 : Practice, Practice, Practice21-14
  • § 21:4 : During an Inspection21-14
    • § 21:4.1 : Generally21-14
    • § 21:4.2 : Questions and Answers21-15
    • § 21:4.3 : Keeping a Record21-16
    • § 21:4.4 : Close-Out Meetings21-16
  • § 21:5 : Post-Inspection Follow-Up21-17
    • § 21:5.1 : 483 Response21-17
      • [A] : Generally21-17
      • [B] : Timeline21-17
      • [C] : How to Address and Format Your Response21-18
      • [D] : Tips for Success21-18
    • § 21:5.2 : Close Out and the Establishment Inspection Report21-19
    • § 21:5.3 : Publicity21-19
    • § 21:5.4 : Warning Letter Response21-20
      • [A] : Generally21-20
      • [B] : Timeline21-20
      • [C] : How to Address and Format Your Response21-21
      • [D] : Tips for Success21-21
Chapter 22: Issues Arising from Criminal Cases
  • § 22:1 : Overview22-2
  • § 22:2 : How Does a Criminal Investigation Commence?22-3
    • § 22:2.1 : Generally22-3
    • § 22:2.2 : Agencies That Investigate and Prosecute FDA Criminal Matters22-3
      • [A] : Criminal Investigators22-3
        • [A][1] : FDA Office of Criminal Investigations22-3
        • [A][2] : Federal Bureau of Investigation22-6
        • [A][3] : U.S. Department of Health and Human Services Office of Inspector General22-7
        • [A][4] : Others22-7
      • [B] : Criminal Prosecutors22-7
    • § 22:2.3 : Regulatory Referrals22-7
    • § 22:2.4 : Consumer Complaints and Public Health Issues22-8
    • § 22:2.5 : Whistleblowers, the False Claims Act, and Qui Tams22-8
  • § 22:3 : Parallel Investigations—Government Sharing of Information22-9
  • § 22:4 : Indications That There May Be a Criminal Investigation22-9
    • § 22:4.1 : Generally22-9
    • § 22:4.2 : Document Requests22-9
      • [A] : Grand Jury Subpoenas22-9
      • [B] : HIPAA Subpoenas22-10
      • [C] : Other Administrative Subpoenas22-11
      • [D] : Privilege Issues, Self-Incrimination, and Immunity22-11
        • [D][1] : Attorney-Client Privilege22-11
        • [D][2] : Attorney Work Product Protection22-12
        • [D][3] : Fifth Amendment Privilege Against Self-Incrimination22-13
    • § 22:4.3 : Testimonial Subpoenas22-15
      • [A] : Generally22-15
      • [B] : Grand Jury Secrecy22-16
        • [B][1] : Generally22-16
        • [B][2] : Government Obligations22-17
        • [B][3] : No Obligations on Other Persons22-17
    • § 22:4.4 : Interviews22-18
      • [A] : Generally22-18
      • [B] : Represented Parties and Persons22-18
        • [B][1] : Current Employees22-18
        • [B][2] : Former Employees22-20
      • [C] : Restrictions on the Government22-20
      • [D] : Ethical Issues for Company Counsel and Upjohn Warnings22-20
      • [E] : Joint Defense Agreements22-22
    • § 22:4.5 : Search Warrants22-23
      • [A] : Generally22-23
      • [B] : General Requirements in Issuing and Serving a Search Warrant22-23
      • [C] : Practical Considerations22-25
  • § 22:5 : Influencing the Criminal Investigation22-26
    • § 22:5.1 : Voluntary Disclosure22-26
    • § 22:5.2 : Proffer Sessions and Government Presentations22-27
  • § 22:6 : Plea Negotiations22-28
    • § 22:6.1 : Generally22-28
    • § 22:6.2 : Sentencing Guidelines—Organizational Guidelines22-28
      • [A] : Compliance Programs22-28
    • § 22:6.3 : Non-Prosecution and Deferred Prosecution Agreements22-29
    • § 22:6.4 : Collateral Consequences—Exclusion and Debarment22-29
  • § 22:7 : Select Constitutional Defenses22-30
    • § 22:7.1 : First Amendment22-30
    • § 22:7.2 : Fifth Amendment Due Process (Clarity of the Law)22-32
  Table of Authorities
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