TreatiseAnswer Book

Pharmaceutical Compliance and Enforcement Answer Book (2017 Edition)

 by Howard L Dorfman
 
 Copyright: 2017

 Product Details >> 

Product Details

  • ISBN Number: 9781402428425
  • Page Count: 618
  • Number of Volumes: 1
  •  

Pharmaceutical Compliance and Enforcement Answer Book provides a comprehensive overview of the regulatory issues faced by the different participants in the pharmaceutical industry.

In an easy Q&A format, this resource discusses:

  • The FDA's authority and potential actions to regulate prescription drugs and biologics both before and after approval by the agency
  • A facility's rights and compliance obligations during an inspection by the agency
  • How to best evaluate a company's potential of being in violation and what to do to mitigate those risks
  • What advertising and promotion of prescription drugs is permitted
  • How product liability issues overlap with FDA enforcement initiatives
  • When criminal prosecution is used as part of the regulatory enforcement effort
Filled with practical suggestions, Pharmaceutical Compliance and Enforcement Answer Book provides attorneys and compliance officers with a roadmap to effective compliance with FDA pharmaceutical regulations.
  Preface
  Table of Contents
Chapter 1: FDA Enforcement Pre- and Post-Approval and the 21st Century Cures Act
  • : Introductory Definitions3
  • Q 1.1 : What is FDA?3
  • Q 1.2 : What is the Federal Food, Drug, and Cosmetic Act?3
  • Q 1.3 : What is a drug?3
  • Q 1.4 : What is a new drug?4
  • Q 1.5 : What is a biologic?4
  • Q 1.6 : What is an IND?4
  • Q 1.7 : What is a clinical trial?4
  • Q 1.8 : What is an IRB?5
  • Q 1.9 : What is an NDA?5
  • Q 1.10 : What is a BLA?5
  • Q 1.11 : What is an ANDA?5
  • Q 1.12 : What is a 351(k) application?5
  • Q 1.13 : What is a 505(b)(2) application?6
  • Q 1.14 : What is a generic drug?6
  • Q 1.15 : What is a biosimilar product?6
  • : FDA’s Enforcement Authority6
  • Q 1.16 : What is the source of FDA’s enforcement authority with respect to drugs and biologics?6
    • Q 1.16.1 : What is the source of FDA authority with respect to drugs pre-approval?7
    • Q 1.16.2 : What is the source of FDA authority with respect to drugs post-approval?7
  • Q 1.17 : What is the rationale behind FDA enforcement?7
  • : Pre-Approval Regulation8
  • Q 1.18 : What approval does FDA require for the permissible sale of innovator drugs?8
  • Q 1.19 : How does a manufacturer obtain FDA approval to sell an innovator drug?8
    • Q 1.19.1 : What is the research process involved in seeking approval for an innovator drug?9
    • Q 1.19.2 : What are the phases of clinical testing that lead to approval?10
    • Q 1.19.3 : When is IRB approval necessary?11
    • Q 1.19.4 : Who conducts the clinical trials?11
    • Q 1.19.5 : What are a sponsor’s and investigator’s responsibilities in conducting a clinical trial?12
    • Q 1.19.6 : What registration requirements apply to clinical trials?13
    • Q 1.19.7 : What are the standards of approval for an NDA?15
    • Q 1.19.8 : What is the “substantial evidence” standard?16
    • Q 1.19.9 : What are fast track, breakthrough therapy, accelerated approval, and priority review?16
    • Q 1.19.10 : Under what circumstances is a 505(b)(2) application appropriate?18
  • Q 1.20 : What approval does FDA require for the sale of generic drugs?19
  • Q 1.21 : How does a manufacturer obtain FDA approval to sell a generic drug?19
  • Q 1.22 : How does a manufacturer obtain FDA approval to sell a biologic?20
    • Q 1.22.1 : How does a manufacturer obtain FDA approval to sell a biosimilar product?20
  • Q 1.23 : How does FDA communicate its approval decisions?21
  • : Post-Approval Regulation21
  • Q 1.24 : What post-approval acts can FDA require a manufacturer to undertake?21
  • Q 1.25 : When does FDA reconsider or withdraw approval of a drug?22
  • Q 1.26 : How does FDA regulate manufacturing practices?23
  • Q 1.27 : What drug-related communications does FDA regulate?24
    • Q 1.27.1 : What is a drug’s labeling?25
    • Q 1.27.2 : What standards and prohibitions apply to labeling?25
    • Q 1.27.3 : What is a drug’s advertising?26
    • Q 1.27.4 : What standards and prohibitions apply to advertisements?26
    • Q 1.27.5 : How does FDA regulate drug promotion?27
    • Q 1.27.6 : What is off-label promotion?28
  • Q 1.28 : What are FDA’s formal enforcement tools?29
  • : FDA Regulation Generally31
  • Q 1.29 : How does FDA communicate its enforcement policies and priorities, as well as guidance on compliance?31
  • Q 1.30 : What FDA divisions perform enforcement activities?32
  • Q 1.31 : When does FDA collaborate with other agencies to meet enforcement objectives?32
  • : The 21st Century Cures Act and Its Potential Impact on Pre- and Post-Approval FDA Regulation33
  • Q 1.32 : How does the Cures Act address drug development in relation to the current FDA procedures for pre- and post-approval FDA regulation?33
  • Q 1.33 : What is the anticipated role of “Patient Experience Data” in the clinical research process under the Cures Act?33
  • Q 1.34 : How are various drug development tools addressed in the Cures Act?34
  • Q 1.35 : How will acceptable clinical trial designs change under the Cures Act?34
  • Q 1.36 : What role will “real-world evidence” assume under the Cures Act?34
  • Q 1.37 : What is the definition and scope of a “qualified data summary”?35
  • Q 1.38 : How does the Cures Act address the issue of “expanded access”?36
Chapter 2: FDA Enforcement—Facility Inspections
  • : FDA Inspection Basics54
  • Q 2.1 : What does FDA inspect?54
  • Q 2.2 : When does/can FDA inspect an establishment/firm/company?54
  • Q 2.3 : What are the types of inspection?55
  • Q 2.4 : Can the company refuse an inspection?55
  • : The Inspection55
  • Q 2.5 : How should an onsite inspector visit be handled?55
  • Q 2.6 : Who does FDA see—Legal, Quality, or Management?56
  • Q 2.7 : What documentation is subject to inspection?57
    • Q 2.7.1 : How should a company handle an inspector request to review records that are not subject to inspection?57
  • Q 2.8 : Does the company have to provide deviations, change controls, complaints, and rejected batches in an electronic format rather than just paper?57
    • Q 2.8.1 : Does the company have to grant FDA access to “live” demos of their systems?57
  • Q 2.9 : If there are specific requirements in site SOPs (no cosmetics, for instance) to which inspectors are unwilling to conform, can access be denied to those areas?58
    • Q 2.9.1 : If an inspector comes to the site during non-business hours, is the company obligated to bring in the appropriate personnel?58
  • Q 2.10 : How should a company handle an inspector whose questions are outside the scope of the inspection?58
    • Q 2.10.1 : If an adversarial relationship develops during an inspection, is there an opportunity to replace the inspector?58
    • Q 2.10.2 : Does a company have the right to refuse permission to take photographs during an inspection?59
  • : Post-Inspection59
  • Q 2.11 : What are the possible results of an inspection?59
    • Q 2.11.1 : If the company disagrees with an observation, or believes it is incorrectly stated, what are the company’s options?60
  • Q 2.12 : Why are U.S. firms inspected without notice?61
  • : Non-FDA Regulations62
  • Q 2.13 : If an inspector has seen a certain practice in one company does he/she have the right to mandate adoption to others?62
  • : Foreign Complaints62
  • Q 2.14 : Can FDA enforce compliance on a company for issues/complaints that did not originate in the United States?62
Chapter 3: 483s and Warning Letters
  • : Form FDA 48366
  • : FDA Inspections66
  • Q 3.1 : What is an FDA inspection?66
  • Q 3.2 : Are FDA inspections subject to prior notification?67
  • : Form FDA 483 Basics67
  • Q 3.3 : What is a Form FDA 483?67
  • Q 3.4 : Are FDA observations in a 483 necessarily violations?68
  • Q 3.5 : When will my firm receive a 483?68
  • Q 3.6 : What are the elements of a 483?69
  • : Avoiding, Correcting, and Annotating 483 Observations70
  • Q 3.7 : What should be done to avoid observations in a 483?70
  • Q 3.8 : What should be done at a close-out meeting?71
  • : Responding to a 48372
  • Q 3.9 : How quickly should we respond to a 483?72
  • Q 3.10 : Who should be involved in preparing a 483 response?72
  • Q 3.11 : Can we sue the Food and Drug Administration in response to a 483?73
  • Q 3.12 : What are the elements of a good 483 response?73
  • Q 3.13 : What if I don’t understand an observation in a 483?75
  • Q 3.14 : When is it appropriate to address personnel issues in a 483 response?76
  • Q 3.15 : Should a 483 response note that the company has brought in outside expert resources to assist in addressing one or more observations?76
  • Q 3.16 : Who should sign a response to a 483?76
  • Q 3.17 : To whom should the 483 response be sent?77
  • Q 3.18 : Should proprietary information be included in a 483 response?77
  • : Meeting with FDA78
  • Q 3.19 : Should we try to meet with FDA after receiving a 483?78
  • : Dispute Resolution78
  • Q 3.20 : What are the mechanisms for dispute resolution around 483s and Warning Letters?78
  • : Establishment Inspection Reports79
  • Q 3.21 : What is an Establishment Inspection Report?79
  • Q 3.22 : How do I obtain a copy of an EIR for an inspection of my facility?79
  • Q 3.23 : Are 483s and EIRs available to the public under the Freedom of Information Act?80
  • : Warning Letters80
  • : Warning Letter Basics80
  • Q 3.24 : What is a Warning Letter?80
    • Q 3.24.1 : What is an Untitled Letter?81
  • Q 3.25 : What are the elements of a Warning Letter?81
  • Q 3.26 : What factors increase the likelihood of a Warning Letter?83
  • : Timing85
  • Q 3.27 : Must FDA send a Warning Letter before taking enforcement action?85
  • Q 3.28 : How quickly will a Warning Letter be issued after issuance of a 483?86
  • : Process for Issuance86
  • Q 3.29 : What is the process for issuing a Warning Letter?86
  • : Impact of a Warning Letter87
  • Q 3.30 : What impact does a Warning Letter have on a company’s government contracts?87
  • : Responding to a Warning Letter87
  • Q 3.31 : Can a firm sue FDA in response to a Warning Letter?87
  • Q 3.32 : How quickly should we respond to a Warning Letter?88
  • Q 3.33 : What is an appropriate Warning Letter response?88
  • Q 3.34 : Who should sign a response to a Warning Letter?89
  • Q 3.35 : Are Warning Letters available to the public? What about the recipient’s responses?90
  • : FDA Receipt of a Warning Letter Response90
  • Q 3.36 : What does FDA do when it receives a response to a Warning Letter?90
  • Q 3.37 : What is a “Close-Out” Letter?90
Chapter 4: FDA Regulations and Enforcement Actions Relative to Oversight of Advertising and Promotion
  • : FDA Responsibility for Oversight of Advertising and Promotion96
  • Q 4.1 : What centers within FDA are responsible for oversight of the advertising and promotion of FDA-regulated products?96
  • Q 4.2 : What are the responsibilities of these centers?97
  • : Controlling Statutes and Regulations97
  • : Controlling Law97
  • Q 4.3 : What statutes and regulations control pharmaceutical marketing and promotion?97
  • : FDA Authority Over Prescription Drug-Related Promotional Material98
  • Q 4.4 : What information in prescription drug-related promotional material does FDA control?98
  • Q 4.5 : Are promotional materials required to be pre-approved by FDA?98
  • Q 4.6 : When must promotional materials be submitted to FDA?99
    • Q 4.6.1 : Are there exceptions to the time of submission of promotional materials to FDA?99
  • Q 4.7 : How does FDA evaluate whether promotional material is in violation of the FDCA and its regulations?99
  • : FDA Treatment of Different Types of Prescription Drug Promotional Material100
  • Q 4.8 : How does FDA treat different types of promotional material for prescription drugs?100
  • Q 4.9 : What is the difference between the professional label and promotional labeling?101
  • Q 4.10 : What is a “reminder advertisement”?101
  • Q 4.11 : What is a “help-seeking advertisement”?102
  • Q 4.12 : What is a “product claim advertisement”?102
    • Q 4.12.1 : What is a “broadcast advertisement”?102
    • Q 4.12.2 : What must be included in a broadcast advertisement’s “major statement”?103
    • Q 4.12.3 : What must be included in the “brief summary”?103
    • Q 4.12.4 : What is a “consumer brief summary”?104
    • Q 4.12.5 : How do the requirements for print advertisements differ from broadcast advertisements?104
  • : Enforcement Actions105
  • Q 4.13 : What are some of the most common grounds for enforcement action by FDA related to promotional materials?105
  • Q 4.14 : What actions can the government take regarding improper promotion of pharmaceuticals?105
  • Q 4.15 : What is a “Warning Letter”?105
    • Q 4.15.1 : Under what circumstances does FDA issue a Warning Letter?106
    • Q 4.15.2 : What information is included in a Warning Letter?106
  • Q 4.16 : What is an “Untitled Letter”?107
  • Q 4.17 : Which FDA offices have authority to issue Warning Letters or Untitled Letters?107
  • Q 4.18 : Are Warning Letters and Untitled Letters available to the public?107
  • Q 4.19 : How should the recipient of a Warning Letter or Untitled Letter respond?108
  • Q 4.20 : How are Warning Letter matters concluded?109
  • : FTC110
  • Q 4.21 : What is the role of the FTC with respect to advertising of products regulated by FDA?110
  • : Bad Ad Program110
  • Q 4.22 : What is the “Bad Ad Program”?110
  • : Internet and Social Media in the Promotion of FDA-Regulated Products111
  • Q 4.23 : What have been some of the recent specific enforcement actions taken in relation to promotion via the Internet?111
  • Q 4.24 : How has FDA reacted to the growing interest in the use of the Internet and social media in the promotion of FDA-regulated products?112
  • Q 4.25 : What are the top issues facing those interested in the promotion of FDA-regulated products via social media?115
  • Q 4.26 : What have been some of the messages of Warning Letters and Untitled Letters issued in relation to promotion via the Internet and social media since the April 2009 Untitled Letters?115
  • : FDA Advisory Opinions116
  • Q 4.27 : Does FDA issue Advisory Opinions?116
Chapter 5: Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers’ Advertising and Promotional Activity
  • : Basics of Pharmaceutical Advertising and Promotion Regulation125
  • : Definition of “Promotion” and “Advertising” by a Pharmaceutical Manufacturer125
  • Q 5.1 : What is “promotion” and “advertising” by a pharmaceutical manufacturer?125
  • : Regulating Federal Agencies127
  • : Generally127
  • Q 5.2 : Which federal agencies regulate pharmaceutical advertising and promotion?127
  • : Food and Drug Administration127
  • Q 5.3 : Which offices and centers within FDA regulate pharmaceutical advertising and promotion?127
  • Q 5.4 : Does FDA provide guidance to pharmaceutical manufacturers regarding appropriate advertising and promotion?128
  • Q 5.5 : What type of enforcement activity does FDA take against pharmaceutical manufacturers for inappropriate advertising and promotion?128
  • : Federal Trade Commission130
  • Q 5.6 : What is the role of the Federal Trade Commission in regulating pharmaceutical advertising and promotion?130
  • Q 5.7 : What powers are provided to the FTC to enforce the FTCA?130
  • Q 5.8 : Is there coordination between FDA and the FTC relevant to pharmaceutical advertising and promotion?131
  • Q 5.9 : What enforcement activity has the FTC taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?132
  • : Department of Justice133
  • Q 5.10 : What is the role of the DOJ in regulating pharmaceutical advertising and promotion?133
  • Q 5.11 : What is the Federal False Claims Act?133
  • Q 5.12 : What are the whistleblower provisions of the Federal False Claims Act?133
  • Q 5.13 : Is there coordination between FDA and the DOJ relevant to pharmaceutical advertising and promotion?134
  • Q 5.14 : What enforcement activity has the DOJ taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?135
  • : DHHS Office of Inspector General136
  • Q 5.15 : What is the role of the OIG in regulating pharmaceutical advertising and promotion?136
  • Q 5.16 : Does the OIG provide guidance to pharmaceutical manufacturers regarding appropriate advertising and promotion?136
  • Q 5.17 : May a pharmaceutical manufacturer report potential noncompliance to the OIG?137
  • Q 5.18 : Is there coordination between FDA, DOJ, and OIG relevant to pharmaceutical advertising and promotion?139
  • Q 5.19 : What types of enforcement activity are available to the OIG?139
    • Q 5.19.1 : What is the OIG administrative power to exclude individuals or entities?140
    • Q 5.19.2 : What is a CIA and what does it require?141
  • : Regulating State Agencies142
  • : Generally142
  • Q 5.20 : Which state agencies regulate pharmaceutical advertising and promotion?142
  • : State Attorneys General142
  • Q 5.21 : What is the role of state attorneys general in regulating pharmaceutical advertising and promotion?142
  • Q 5.22 : How do state attorneys general coordinate with federal enforcement authorities related to pharmaceutical advertising and promotion?143
  • Q 5.23 : What enforcement activity have state attorneys general taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?144
  • : Medicaid Fraud Control Units145
  • Q 5.24 : What is the role of the Medicaid Fraud Control Units in regulating pharmaceutical advertising and promotion?145
  • Q 5.25 : How do the Medicaid Fraud Control Units coordinate with federal enforcement authorities related to pharmaceutical advertising and promotion?145
  • Q 5.26 : What enforcement activity have the Medicaid Fraud Control Units taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?146
  • : Expansion of Federal Law146
  • Q 5.27 : How did the Fraud Enforcement and Recovery Act of 2009 (FERA)impact the regulation of pharmaceutical advertising and promotion?146
  • Q 5.28 : How did the Patient Protection and Affordable Care Act (PPACA) impact the regulation of pharmaceutical advertising and promotion?147
  • : Compliance Considerations and Better Practices for Pharmaceutical Manufacturers148
  • Q 5.29 : What are some compliance considerations and better practices for pharmaceutical manufacturers relevant to promotional and advertising activities?148
  • Q 5.30 : What are some compliance considerations and better practices related to the code of conduct and written policies and procedures?148
  • Q 5.31 : What are some compliance considerations and better practices related to advertising/promotional review?149
  • Q 5.32 : What are some compliance considerations and better practices related to compliance monitoring and auditing activities?150
Chapter 6: Regulatory and Compliance Implications of Disseminating Medical Information and the Distinction with Off-Label Promotion
  • : Statutory Basis for FDA and Government Oversight159
  • Q 6.1 : What is the statutory basis for government action against pharmaceutical manufacturers involving allegations of off-label promotion?159
  • Q 6.2 : Are there other statutes that implicate illegal off-label promotion?161
  • : Off-Label Activities162
  • Q 6.3 : What is the impact of standards of medical practice on the manufacturer’s dissemination of medical and scientific information relating to indications not reflected in a product’s approved product labeling?162
  • Q 6.4 : What constitutes “Off-Label Prescribing”?163
  • Q 6.5 : What activities constitute dissemination of medically relevant and accurate scientific and medical information outside of approved labeling?164
  • Q 6.6 : What activities constitute “Off-Label Promotion”?164
    • Q 6.6.1 : What are the regulatory implications for companies in the disclosure of clinical trial results?168
  • : Social Media and Off-Label Promotion168
  • : FDA Case-By-Case Evaluation and Industry-Created Practices168
  • Q 6.7 : What is the impact of social media on off-label promotion?168
  • : FDA Draft Guidance (2011–2014)170
  • Q 6.8 : What guidance has FDA provided relating to the use of social media in a promotional context?170
  • Q 6.9 : How does the Draft Guidance address “unsolicited” requests for off-label information?172
  • : FDA Draft Guidance Impact on Industry Practice173
  • Q 6.10 : What kinds of electronic media usage have the potential for off-label promotion?173
  • Q 6.11 : What are some of FDA’s articulated concerns relative to electronic media?173
    • Q 6.11.1 : What procedures does FDA recommend a company take in responding to requests made online?174
    • Q 6.11.2 : What additional guidance has FDA provided in the context of social media and its impact on regulatory and compliance concerns?176
    • Q 6.11.3 : Has FDA issued any additional guidance regarding social media since 2014? Are any anticipated?178
    • Q 6.11.4 : Has FDA taken any regulatory action against a pharmaceutical manufacturer based on promotion on social media since the draft guidances were issued?178
    • Q 6.11.5 : What is the most recent pronouncement by FDA regarding medical products communication?179
  • : Oversight by the Executive Branch, Judicial Branch, and State Governments182
  • : Generally182
  • Q 6.12 : Does FDA have sole responsibility for supervising and restricting dissemination of scientific information relating to the authority to take action for alleged off-label promotion?182
  • : Office of Inspector General and Department of Justice183
  • Q 6.13 : What have been the results of recent government actions relating to off-label promotions on the pharmaceutical industry?183
  • Q 6.14 : What kinds of settlements with pharmaceutical companies has the government been able to secure?184
  • Q 6.15 : How will the most recent corporate integrity agreements impact the various functions of pharmaceutical manufacturers?202
  • : Judicial System206
  • Q 6.16 : What role does the judicial system play in determining limits on the dissemination of truthful, non-misleading (albeit off-label) medical and scientific information?206
  • : State Actions207
  • Q 6.17 : What actions have states taken to address the off-label issue?207
Chapter 7: Current Status of the Impact of the First Amendment on Off-Label Promotion
  • : Early First Amendment Challenges and FDA Reaction216
  • Q chap07_7.1 : How have courts addressed the question of whether the First Amendment affects a pharmaceutical manufacturer’s promotional activities involving information not contained in approved FDA labeling?216
  • Q chap07_7.2 : Does FDA recognize a public health interest in the dissemination of truthful and non-misleading medical information even if off-label?218
  • Q chap07_7.3 : Has FDA provided guidance to manufacturers on the dissemination of off-label information?218
  • Q chap07_7.4 : Does FDA Guidance provide a “safe harbor” for a pharmaceutical company in disseminating off-label reprints?218
    • Q chap07_7.4.1 : What steps should a pharmaceutical company take to take advantage of the “safe harbor”?219
    • Q chap07_7.4.2 : Has FDA updated the Guidance since its release in 2009?220
  • : The Caronia Decision222
  • Q chap07_7.5 : Have there been any successful First Amendment challenges to prosecutions of pharmaceutical representatives allegedly promoting a drug for off-label or unapproved uses?222
  • Q chap07_7.6 : What were the facts of Caronia?222
  • Q chap07_7.7 : Why was Caronia’s conviction reversed?223
  • Q chap07_7.8 : Does Caronia mean that off-label promotion is legal?223
  • : Additional First Amendment Challenges224
  • Q chap07_7.9 : What is the current environment for government oversight of the dissemination of off-label medical and scientific information?224
  • Q 7.10 : What is the current and potential future position of the U.S. Supreme Court on the FDA’s authority to limit off-label promotion?225
  • Q 7.11 : Have courts in the Second Circuit dealt with off-label promotion cases since Caronia was decided?227
  • Q 7.12 : What circumstances led to the Amarin litigation?227
  • Q 7.13 : What was the outcome of Amarin’s First Amendment challenge?228
  • Q 7.14 : What gave rise to Pacira’s suit against FDA?229
  • Q 7.15 : How did the court rule on Pacira’s First Amendment argument?230
  • Q 7.16 : What do Caronia, Amarin, and Pacira mean for the pharmaceutical industry?230
  • Q 7.17 : How has industry responded to these cases?231
  • Q 7.18 : Has FDA taken any action to address off-label promotion after these cases?232
  • Q 7.19 : What actions did FDA take after conducting the public hearing?233
  • Q 7.20 : What does the Consistent Communications Draft Guidance say?234
  • Q 7.21 : What is the significance of FDA’s memorandum?237
  • Q 7.22 : How does the 21st Century Cures Act impact off-label communications by pharmaceutical companies?238
Chapter 8: Food and Drug Administration Amendments Act of 2007 and the Growth of FDA Enforcement Authority
  • : Post-Market Studies and Post-Market Clinical Trials247
  • Q 8.1 : Can prescription drug manufacturers be required to conduct studies or clinical trials of a drug product after its approval?247
  • Q 8.2 : Is there a difference between a post-market “study” and a post-market “clinical trial”?248
  • Q 8.3 : When is FDA authorized to require post-market studies or post-market clinical trials?248
  • Q 8.4 : What is a “serious risk,” a “signal of a serious risk,” and an “unexpected serious risk”?249
  • Q 8.5 : What does the term “new safety information” mean for purposes of requiring post-market studies or post-market clinical trials after approval of a drug product?250
  • Q 8.6 : Are there circumstances under which FDA will request a sponsor to voluntarily agree to conduct post-market studies or clinical trials rather than require them to do so under the new FDAAA provisions?250
  • Q 8.7 : What is the process for FDA to require a post-market study or post-market clinical trial under FDAAA?251
  • Q 8.8 : How does FDA determine whether post-market studies or post-market clinical trials are proceeding in accordance with the established timetable?252
  • Q 8.9 : Are there any penalties for failing to comply with PMR requirements?252
  • : Authority to Mandate Safety Labeling Changes253
  • Q 8.10 : Can FDA require companies to revise the approved labeling of their marketed drug and biological products?253
  • Q 8.11 : Does FDA’s authority to require safety labeling changes apply to all drug and biological products?254
  • Q 8.12 : Can FDA order changes to any portion of a covered product’s approved labeling?254
  • Q 8.13 : What is the process for FDA to require safety labeling changes?255
  • Q 8.14 : If a sponsor intends to propose a safety labeling change, what type of supplement should be submitted?256
  • Q 8.15 : Is FDA subject to any deadlines for responding to a sponsor’s supplement or rebuttal statement?256
  • Q 8.16 : What happens if FDA and the sponsor cannot agree on labeling language?257
  • Q 8.17 : Should the FDAAA process be used if the sponsor, rather than FDA, first becomes aware of “new safety information”?258
  • Q 8.18 : Are there penalties for failing to comply with a safety labeling change order?258
  • : Risk Evaluation and Mitigation Strategies259
  • Q 8.19 : What is a REMS?259
  • Q 8.20 : What are the standards for imposing a REMS?259
  • Q 8.21 : If FDA decides to impose a REMS, what specific risk management tools can it require to be used?260
  • Q 8.22 : Under what circumstances can FDA impose a distribution or use restriction as an ETASU?261
  • Q 8.23 : Can a REMS be modified?262
  • Q 8.24 : How does FDA process proposed REMS and REMS assessments?262
  • Q 8.25 : Do the REMS provisions apply to generic drugs?263
  • Q 8.26 : How is a REMS applied when a safety issue affects a class of products?263
  • Q 8.27 : Are there penalties for failing to comply with a REMS requirement?264
  • : Civil Money Penalties for REMS and Other Post-Market Safety Violations264
  • Q 8.28 : Can FDA impose CMPs for violations of the FDAAA provisions discussed above governing post-approval drug safety?264
  • : Selected Advertising Provisions of FDAAA265
  • : Pre-Review of Television Advertisements265
  • Q 8.29 : Can FDA require companies to submit advertisements for review prior to dissemination?265
  • Q 8.30 : Can FDA require modifications to television advertisements submitted for pre-review?265
  • : Major Statement in Radio and Television Advertisements266
  • Q 8.31 : Does FDAAA affect how risk information is communicated in DTC advertisements?266
  • Q 8.32 : Has FDA provided guidance on what “clear, conspicuous, and neutral” means?267
  • : Other Advertising Provisions267
  • Q 8.33 : Did FDAAA include other provisions applicable to drug advertising?267
  • : Civil Money Penalties for DTC Advertising Violations268
  • Q 8.34 : Can FDA impose CMPs for advertising violations?268
  • Q 8.35 : What are the procedures for imposing CMPs for advertising violations?268
    • Q 8.35.1 : Has FDA ever used its new authority to impose CMPs for advertising violations?269
  • : Clinical Trial Registries and Results Databases269
  • : Overview269
  • Q 8.36 : Are prescription drug manufacturers subject to requirements for registering clinical trials on a publicly accessible, government database?269
  • Q 8.37 : What is the clinical trial registry database?270
  • Q 8.38 : What is the clinical trial results database?270
  • Q 8.39 : Who is responsible for submitting clinical trial information to CT.gov in accordance with the FDAAA requirements?270
  • Q 8.40 : Do the federal reporting requirements for clinical trial registries and results databases apply to all clinical trials involving a pharmaceutical or biological product?271
  • : Foreign Clinical Studies272
  • Q 8.41 : If a drug trial is being conducted in a foreign country, is the sponsor required to submit information about it to CT.gov?272
  • : Applicable Drug Clinical Trials272
  • Q 8.42 : Does information about observational studies need to be submitted to CT.gov?272
  • Q 8.43 : If the FDAAA requirements apply, when must a sponsor submit information about a drug trial to the clinical trial registry database?273
  • Q 8.44 : What type of information must be submitted to the clinical trial registry for each “applicable drug clinical trial”?273
  • : Public Availability of Registry and Results Information274
  • Q 8.45 : Does NIH make registry information publicly available at or near the time it is submitted to CT.gov?274
  • Q 8.46 : Does FDAAA require a sponsor to submit results information for each drug study for which registry information has been submitted to CT.gov?274
  • : Timing of Submissions274
  • Q 8.47 : If results information is required, when must it be submitted to CT.gov and by whom?274
  • Q 8.48 : Are there any mechanisms to delay the deadline for submission of results information?275
  • : Results Information and Reporting Requirements276
  • Q 8.49 : If required, what type of results information must be submitted to CT.gov for each applicable drug clinical trial?276
  • Q 8.50 : Are sponsors required to update their submissions to CT.gov?277
  • Q 8.51 : Are there any state clinical trial reporting requirements?277
  • : Compliance and Enforcement277
  • Q 8.52 : What are the consequences for failure to comply with the clinical trial reporting requirements under FDAAA?277
  • Q 8.53 : How does the government monitor compliance?278
Chapter 9: Risk Evaluation and Mitigation Strategies (REMS) and Related Post-Market Safety Oversight
  • : Basics of REMS288
  • Q 9.1 : What are REMS? When was that term first introduced?288
  • Q 9.2 : How do REMS compare to RiskMAPs?288
  • : REMS Development and Oversight289
  • Q 9.3 : What is the name of the government entity that handles REMS development and oversight?289
  • Q 9.4 : When can a REMS be required and how are REMS for particular products or classes of products devised?289
  • Q 9.5 : Are there any advantages to a company proactively suggesting REMS for a particular product to FDA?290
  • Q 9.6 : Who within a company is typically involved in devising a REMS plan?291
  • Q 9.7 : What are some typical components of REMS?292
  • Q 9.8 : Are ANDA holders subject to the same requirements for REMS as NDA holders?293
  • Q 9.9 : Are periodic assessments necessary to determine if a REMS is working and if so, how are such assessments typically performed?293
  • Q 9.10 : Is there a defined process for modifying or revising approved REMS?294
  • : Post-Market Safety Oversight295
  • Q 9.11 : Can a product with REMS still be subject to market withdrawal or product liability lawsuits by patients alleging harm from such drugs?295
  • Q 9.12 : Can a REMS be mandated after a drug is already on the market?296
  • Q 9.13 : Are there any penalties for noncompliance with REMS?297
  • Q 9.14 : How many REMS programs are currently in place? Where can I find information about a particular product’s REMS?297
  • Q 9.15 : Were there drugs approved before FDAAA that were later deemed to have REMS?298
  • Q 9.16 : If a drug has a medication guide, does this mean it is subject to REMS?298
  • Q 9.17 : What other types of post-market safety oversight exist to monitor drug safety?299
  • Q 9.18 : How are spontaneous adverse event reports made? How are physicians and patients given information about how to report adverse events?299
  • Q 9.19 : Do companies have an obligation to conduct additional clinical trials or other testing to continue to evaluate a drug’s safety after FDA approval?299
  • Q 9.20 : What is a “signal” and how is a signal identified once a drug is being marketed?300
  • Q 9.21 : What steps must a prudent company take if a signal is identified? Will a signal of a serious adverse event result in withdrawal of the product from the market?301
  • Q 9.22 : What challenges exist for generic drug companies when seeking to introduce products that are subject to a REMS?301
  • Q 9.23 : What other measures should be considered if a company adopts a REMS?303
  • Q 9.24 : What is the Patients Alliance for Drug Safety Protections?303
  • Q 9.25 : What other initiatives exist with respect to REMS?303
  • Q 9.26 : Is there an obligation on the part of a branded drug company to share its REMS process? Can a branded company impose conditions precedent before engaging in discussions about an FDA-directed shared REMS program? How do antitrust considerations play out?304
  • Q 9.27 : How many Single Shared REMS Programs exist and what types of products are subject to them? What has been FDA’s position on development of such Programs?305
  • Q 9.28 : What further guidance can we expect from FDA about REMS requirements?306
Chapter 10: Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers
  • : Oversight of the Pharmaceutical Industry313
  • Q 10.1 : What is FDA’s regulatory regime applicable to drug manufacturers?313
  • Q 10.2 : How does FDA regulatory regime impact state product liability claims against drug manufacturers?314
  • Q 10.3 : Is oversight of the pharmaceutical industry limited to FDA regulations and authority?315
  • : State Law Tort Claims316
  • : Generally316
  • Q 10.4 : What type of state law tort claims can be asserted against drug manufacturers by consumers of their drugs?316
  • : Drug Manufacturers Failure to Warn317
  • Q 10.5 : What are the general standards for a failure to warn claim in the prescription drug context?317
    • Q 10.5.1 : What is the “learned intermediary doctrine”?318
  • : Manufacturers Drug Labeling320
  • Q 10.6 : Does FDA approval of a manufacturer’s drug labeling impact a manufacturer’s risks of an adverse verdict in a failure to warn claim case under state law?320
  • Q 10.7 : How does FDA define a “label”?320
  • Q 10.8 : Is the brand-name manufacturer responsible for updating drug labels under the FDCA?322
    • Q 10.8.1 : What is the effect of manufacturer responsibility for updating drug labels on state product liability law?323
  • Q 10.9 : Is the generic manufacturer’s responsibility for updating drug labels different from the brand-name manufacturer?324
  • Q 10.10 : What does the FDA’s Proposed Rule say and how would it alter the potential liability of generic drug companies? What about branded companies?325
  • : FDA Preemption of State Law327
  • Q 10.11 : Does the FDCA preempt state law product liability claims against brand-name drug manufacturers and generic drug manufacturers?327
  • Q 10.12 : What is “implied preemption” and how have the courts applied the doctrine to ban claims against drug manufacturers?329
  • : Brand-Name Manufacturer Liability331
  • Q 10.13 : Can the brand-name manufacturer be held liable when the plaintiff purchased product from the generic manufacturer?331
  • : Design Defect Claims332
  • Q 10.14 : Do manufacturers of prescription drugs face the risk of design defect claims? Can a design defect claim against a drug manufacturer be preempted?332
  • : Fraud and Negligence Claims333
  • Q 10.15 : Are claims for fraud and negligence impliedly preempted?333
  • : Risk Management Developments335
  • Q 10.16 : How have the recent developments in risk management affected product liability for pharmaceutical manufacturers?335
  • Q 10.17 : What risk management tool does FDA use?336
  • : FDA and OIG Oversight of Product Liability Exposures338
  • Q 10.18 : What role does FDA and OIG oversight play relative to product liability exposure?338
  • Q 10.19 : Can allegations of off-label promotional activity serve as the basis of a qui tam action under the False Claims Act?340
  • Q 10.20 : What is the potential impact of the new FDA Draft Guidance Relating to “Emerging Signals” on Pharmaceutical Manufacturer Liability?341
Chapter 11: Specific FDA Enforcement Tools
  • : Warning Letters348
  • Q 11.1 : What is a Warning Letter?348
  • Q 11.2 : What is the source of FDA’s authority to issue a Warning Letter?349
  • Q 11.3 : What violations of the FDCA can prompt the issuance of a Warning Letter by FDA?349
  • Q 11.4 : Are there circumstances where a Warning Letter will not be issued prior to an FDA enforcement action?350
  • Q 11.5 : How long does a company have to respond to a Warning Letter?350
  • Q 11.6 : Are Warning Letters available to the public?351
  • Q 11.7 : What is a Warning Letter close-out letter?351
  • : Product Recalls352
  • Q 11.8 : What is a product recall?352
  • Q 11.9 : Does FDA have statutory authority to order a product recall?352
  • Q 11.10 : Under what circumstances can FDA order the recall of medical devices and biologics?352
  • Q 11.11 : Can FDA request that a company conduct a voluntary recall?354
  • Q 11.12 : When a company voluntarily implements a recall, what are the responsibilities of the company and FDA?354
  • Q 11.13 : What is a health hazard evaluation?357
  • Q 11.14 : What are the different recall classifications?358
  • Q 11.15 : What are the differences among a recall, market withdrawal and stock recovery?358
  • Q 11.16 : When is a recall considered complete?359
  • : Import Detentions and Alerts359
  • Q 11.17 : What is an import detention?359
  • Q 11.18 : What is an import alert?360
  • : Product Seizures361
  • Q 11.19 : What is a product seizure?361
  • Q 11.20 : What is the source of FDA’s authority to seize products?361
  • Q 11.21 : Are there different types of seizures that FDA can implement?361
  • Q 11.22 : Under what circumstances may FDA seize a product?362
  • Q 11.23 : Can FDA take possession of a product before a seizure action is filed?363
  • Q 11.24 : What is FDA’s process for seizing products?363
  • Q 11.25 : What must a company do to contest a product seizure?364
  • Q 11.26 : Are there any requirements attendant to an amicable resolution of a seizure action?364
  • : Injunctive Relief364
  • Q 11.27 : May FDA obtain injunctive relief against a company?364
  • Q 11.28 : Under what circumstances may FDA seek an injunction?365
  • Q 11.29 : Can FDA obtain injunctive relief before it affords a company notice and a hearing?366
  • Q 11.30 : What standard must FDA meet to obtain a preliminary injunction?366
  • Q 11.31 : What types of injunctions may FDA seek?367
  • : Civil Money Penalties367
  • Q 11.32 : What is a civil money penalty?367
  • Q 11.33 : Under what circumstances may FDA impose a CMP, and under what legal authority?367
  • Q 11.34 : May FDA impose a CMP against individuals within a company that committed a violation?369
  • Q 11.35 : How does FDA impose a CMP?369
  • Q 11.36 : Are there exceptions to the FDCA’s broad authority to impose CMPs on a medical device manufacturer?370
  • Q 11.37 : Are there limits on FDA’s authority to impose a CMP on drug manufacturers?370
  • Q 11.38 : What factors does FDA consider in determining the amount of a CMP against a medical device company?371
  • Q 11.39 : What factors does FDA consider in determining the amount of a CMP against a drug company for a violation of the laws governing drug advertising?372
  • : Clinical Trial Penalties373
  • Q 11.40 : What is a clinical trial penalty?373
  • Q 11.41 : What is the source of FDA’s authority to impose clinical trial penalties?373
  • Q 11.42 : What types of violations will prompt FDA to impose a clinical trial penalty?373
  • Q 11.43 : Does FDA have the authority to disqualify a clinical trial investigator?374
  • Q 11.44 : What procedures does FDA follow to disqualify a clinical trial investigator?374
  • Q 11.45 : What is a clinical hold letter?375
  • Q 11.46 : Under what circumstances can FDA issue a clinical hold letter?375
  • Q 11.47 : How much time does the company have to respond to a clinical hold letter?376
  • Q 11.48 : How much time does FDA have to take further action after receiving the company’s response to a clinical hold letter?376
  • Q 11.49 : Under what circumstances may FDA terminate a clinical investigation?376
  • : Criminal Penalties377
  • Q 11.50 : Under what authority are criminal prosecutions for violations of the FDCA authorized?377
  • Q 11.51 : Under what circumstances does the FDCA impose criminal liability on corporate executives?377
  • : Withdrawal of Approval378
  • Q 11.52 : Can FDA withdraw its approval of a new drug or medical device application?378
  • Q 11.53 : What is the source of FDA’s authority to withdraw approval of a product?378
  • Q 11.54 : Under what circumstances will FDA withdraw its approval of a new drug application?378
  • Q 11.55 : Under what circumstances will FDA withdraw its approval of a medical device application?379
  • Q 11.56 : What is the process FDA must follow to withdraw approval?379
  • Q 11.57 : Can FDA withdraw approval of a product indication?380
  • : Some Special Enforcement Issues380
  • Q 11.58 : What is FDA’s authority to combat the importation of counterfeit and unapproved drugs?380
  • Q 11.59 : What enforcement actions has FDA taken against manufacturers and sellers of counterfeit and unapproved drugs?381
  • Q 11.60 : What enforcement actions may FDA take against compounding pharmacies?381
  • Q 11.61 : What enforcement actions may FDA take against manufacturers of tobacco products?382
  • Q 11.62 : What are FDA’s enforcement powers for genetically modified foods?382
  • Q 11.63 : What are FDA’s enforcement powers to enforce preventative food safety requirements?383
Chapter 12: Criminal Prosecution as a U.S. Food and Drug Administration Enforcement Tool
  • : Criminal Enforcement: FDA’s Office of Criminal Investigations and Other Governmental Agencies397
  • Q 12.1 : What roles do FDA’s Office of Criminal Investigations and other governmental agencies play in FDA criminal enforcement?397
  • Q 12.2 : What is the structure and role of FDA’s Office of Criminal Investigations?398
  • Q 12.3 : What efforts has FDA undertaken to improve the Office of Criminal Investigations?400
  • Q 12.4 : What role does the U.S. Department of Justice play in prosecuting criminal violations of statutes within FDA’s purview?401
  • Q 12.5 : How do FDA’s criminal enforcement efforts relate to those of the Department of Health and Human Services’ Office of the Inspector General?402
  • Q 12.6 : How does the FDA collaborate with other agencies on criminal investigations?403
  • : FDA Criminal Investigations405
  • Q 12.7 : How does the Office of Criminal Investigations conduct its investigations?405
  • Q 12.8 : What subpoena powers may the government invoke when investigating offenses within the FDA’s purview?406
  • Q 12.9 : How do routine FDA inspections intersect with FDA’s criminal enforcement goals?408
  • : Federal Criminal Charges409
  • : Prerequisites for Filing Charges409
  • Q 12.10 : When does an FDA investigation result in criminal charges?409
  • : FDA’s Determination to Pursue Criminal Prosecution409
  • Q 12.11 : How does FDA determine whether to recommend criminal charges?409
    • Q 12.11.1 : What is a section 305 notice under the FDCA?409
    • Q 12.11.2 : What factors does the Office of Criminal Investigations consider in determining whether to recommend criminal charges?410
  • : The DOJ’s Willingness to Bring Charges411
  • Q 12.12 : What factors do the Consumer Protection Branch and the U.S. Attorneys’ Offices consider in determining whether to bring criminal charges for FDA-related offenses?411
  • Q 12.13 : What individuals will federal prosecutors target for violations of the FDCA?411
  • Q 12.14 : How do federal prosecutors decide whether to bring criminal charges against a corporate entity?413
  • Q 12.15 : What tools can federal prosecutors use to settle criminal charges against corporations?414
  • : Federal Criminal Statutes Jointly Enforced by FDA and the DOJ416
  • : Generally416
  • Q 12.16 : What federal criminal statutes does FDA enforce with the DOJ’s assistance?416
  • : FDCA Provisions Giving Rise to Criminal Liability417
  • Q 12.17 : What conduct does the FDCA proscribe and what are the consequences for engaging in such conduct?417
  • Q 12.18 : What constitutes “adulteration” under the FDCA?417
  • Q 12.19 : What constitutes “misbranding” under the FDCA?418
    • Q 12.19.1 : What guidance has the FDA provided regarding misbranding and social media?419
  • Q 12.20 : What other conduct does the FDCA proscribe?421
  • Q 12.21 : Are violations of the FDCA misdemeanors or felonies?422
  • : Park Doctrine422
  • Q 12.22 : Is criminal intent an element of FDCA charges?422
  • Q 12.23 : How did the Park doctrine originate?423
  • Q 12.24 : What guidelines has FDA established with regard to the Park doctrine?424
  • Q 12.25 : Who can be convicted under the Park doctrine?425
  • Q 12.26 : What conduct might give rise to corporate criminal liability?427
  • : Defenses to FDCA Charges428
  • Q 12.27 : What defenses are available to charges under the FDCA?428
  • Q 12.28 : What must a defendant show to invoke the FDCA’s statutory defenses?429
  • Q 12.29 : What must a defendant show to invoke defenses to a Park doctrine FDCA prosecution?429
  • : Criminal Penalties for FDCA Violations430
  • Q 12.30 : What criminal penalties could be imposed under the FDCA?430
  • : Collateral Consequences That May Accompany an FDCA Conviction431
  • Q 12.31 : What collateral consequences are possible under the FDCA and related laws?431
  • : Criminal and Civil Liability433
  • Q 12.32 : How does criminal liability under the FDCA intersect with civil liability under the False Claims Act?433
  • : Anti-Tampering Act and Other Offenses Under Title 18 of the U.S. Code434
  • Q 12.33 : What other federal statutes does the FDA’s OCI investigate?434
  • Q 12.34 : What conduct does the Federal Anti-Tampering Act prohibit?434
  • Q 12.35 : What criminal penalties may be imposed for a conviction for violating the Federal Anti-Tampering Act?436
  • Q 12.36 : What other statutory offenses may be within FDA’s purview?436
Chapter 13: Pharmaceutical Price Reporting: The “ABCs” and “123s” of Compliance
  • : Federal Prescription Drug Programs: Pricing and Reporting Requirements457
  • : Medicaid Drug Rebate Program (MDRP)457
  • Q 13.1 : What is Medicaid?457
  • Q 13.2 : What is the MDRP?458
  • Q 13.3 : Who is a “manufacturer” under the MDRP?458
  • Q 13.4 : What does the MDRP require of pharmaceutical manufacturers?458
  • Q 13.5 : Have there been recent modifications to the MDRP pricing metrics?460
  • Q 13.6 : Without clear MDRP regulatory guidance, what have been some issues confronted by pharmaceutical manufacturers in their AMP and BP pricing calculations?462
  • Q 13.7 : Has CMS Issued a Final Rule?465
  • : 340B Drug Discount Program (“340B Program”)474
  • Q 13.8 : What is the 340B Program?474
  • Q 13.9 : What does the 340B Program require of pharmaceutical manufacturers?474
  • Q 13.10 : Are 340B covered entities subject to any restrictions?474
  • Q 13.11 : How do 340B covered entities acquire drugs at the 340B price?475
  • Q 13.12 : Are 340B covered entities restricted on the number of its contract pharmacies?475
  • Q 13.13 : Have there been developments over time affecting the 340B Program?476
  • Q 13.14 : What key topics are addressed in the proposed omnibus guidance for the 340B program?482
  • : Department of Veterans Affairs (VA) Drug Discount Program485
  • Q 13.15 : What is the VA drug discount program?485
  • Q 13.16 : What does the VA drug discount program require of pharmaceutical manufacturers?485
  • Q 13.17 : What kind of pharmaceutical products are covered under the VA drug discount program?488
  • Q 13.18 : Are pharmaceutical manufacturers subject to other associated programs for veterans or other military personnel?489
  • : Medicare Part B: Average Sales Price489
  • Q 13.19 : What is Medicare?489
  • Q 13.20 : What kinds of drugs are covered by Part B?490
  • Q 13.21 : What is the Part B prescription drug reimbursement procedure?490
    • Q 13.21.1 : What is the ASP and how is it calculated?490
  • : Government Program Pricing and Reporting: Compliance Risks492
  • : Generally492
  • Q 13.22 : What are the repercussions to a pharmaceutical manufacturer who does not comply with federal healthcare program pricing and reporting obligations?492
  • : CMPs and Administrative Sanctions492
  • Q 13.23 : What noncompliance penalties are assessed by the MDRP?492
  • : Federal False Claims Act (FCA)494
  • Q 13.24 : What is the FCA?494
  • Q 13.25 : What do the terms “knowing” and “knowingly” mean under the FCA?495
  • Q 13.26 : What are the penalties for violation of the FCA?495
  • Q 13.27 : Has there been litigation involving government price reporting under the FCA?496
Chapter 14: The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry
  • : FCPA Basics515
  • Q 14.1 : What FCPA basics should the pharmaceutical industry know?515
  • Q 14.2 : Which U.S. regulators enforce the FCPA?515
  • Q 14.3 : Who is covered by the FCPA?516
  • Q 14.4 : What do the FCPA’s anti-bribery provisions prohibit?517
  • Q 14.5 : Does the FCPA contain any affirmative defenses?518
  • Q 14.6 : Does the FCPA contain any exceptions?519
  • Q 14.7 : What do the FCPA’s accounting provisions require?519
  • Q 14.8 : What fines and penalties may be assessed for FCPA violations?519
  • Q 14.9 : What collateral consequences might arise from an FCPA violation?520
  • Q 14.10 : What other laws are used in conjunction with the FCPA?521
  • : Anti-Bribery Provisions in Detail522
  • : Anything of Value522
  • Q 14.11 : What does the phrase “anything of value” mean?522
  • Q 14.12 : How have cash and cash equivalents featured in FCPA actions?522
  • Q 14.13 : Are travel and entertainment considered “anything of value”?523
  • Q 14.14 : Are gifts considered “anything of value”?524
  • Q 14.15 : Are sponsorships and trainings considered “anything of value”?525
  • Q 14.16 : Are clinical trials and observational studies considered “anything of value”?525
  • Q 14.17 : Are employment and/or consulting agreements considered “anything of value”?526
  • Q 14.18 : Are charitable donations considered “anything of value”?527
  • : Third Parties528
  • Q 14.19 : How do third parties pose FCPA risks?528
  • Q 14.20 : Do joint venture partners pose FCPA risks?529
  • Q 14.21 : Do local agents and consultants pose FCPA risks?530
  • Q 14.22 : Do distributors present unique FCPA risks?531
  • Q 14.23 : Are there FCPA risks associated with travel agents and conference organizers?532
  • Q 14.24 : Do medical foundations and societies present FCPA risks?533
  • : Foreign Officials533
  • Q 14.25 : What is a “foreign official” for purposes of the FCPA?533
  • Q 14.26 : Are HCPs foreign officials?534
  • Q 14.27 : Are pharmacists foreign officials?535
  • Q 14.28 : Are laboratory technicians foreign officials?535
  • Q 14.29 : Are hospital administrators and employees foreign officials?535
  • Q 14.30 : Are healthcare regulators foreign officials?535
  • : Corrupt Intent536
  • Q 14.31 : When are offers, promises, authorizations, or payments made corruptly?536
  • : Business Purpose537
  • Q 14.32 : What does it mean to obtain or retain business?537
  • : Accounting Provisions in Detail537
  • : In General537
  • Q 14.33 : What do the accounting provisions require?537
  • : Books and Records537
  • Q 14.34 : What is the books and records provision?537
  • : Internal Controls538
  • Q 14.35 : What is the internal controls provision?538
  • : Successor Liability539
  • Q 14.36 : Does an acquiring company assume a target’s liability under the FCPA’s anti-bribery provisions?539
  • Q 14.37 : What limitations are there on successor liability?539
  • Q 14.38 : What can an acquiring company do to protect itself from successor liability?540
  • : Mitigating FCPA Risk and Anti-Corruption Compliance Programs541
  • Q 14.39 : How can effective anti-corruption compliance programs help companies mitigate FCPA risk?541
  • Q 14.40 : What does the government expect to see in an anti-corruption compliance program?542
  • Q 14.41 : What additional requirements have pharmaceutical companies agreed to include in their anti-corruption compliance programs when settling with the government?544
  • Q 14.42 : Do expectations for compliance programs vary depending on the jurisdiction and relevant government enforcement agency?545
  • Q 14.43 : How can industry codes inform anti-corruption compliance programs?545
  • Q 14.44 : How can companies mitigate FCPA risk when engaging third parties?546
    • Q 14.44.1 : What additional considerations are there when engaging and working with a distributor?547
    • Q 14.44.2 : What additional considerations are there when engaging an HCP?548
  • Q 14.45 : How can companies mitigate the FCPA risk associated with meals, gifts, and travel?549
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