TreatiseTreatise

   

Pharmaceutical Compliance and Enforcement Answer Book (2018 Edition)

 
 Copyright: 2018

 Product Details >> 

Product Details

  • ISBN Number: 9781402431395
  • Page Count:
  • Number of Volumes:
  •  

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: Overview of the FDA Regulatory Process Pre- and Post-Approval and the 21st Century Cures Act
  • : Introductory Definitions1-3
  • Q chap01_1.1 : What is FDA?1-3
  • Q chap01_1.2 : What is the Federal Food, Drug, and Cosmetic Act?1-3
  • Q chap01_1.3 : What is a drug?1-3
  • Q chap01_1.4 : What is a new drug?1-4
  • Q chap01_1.5 : What is a biologic?1-4
  • Q chap01_1.6 : What is an IND?1-4
  • Q chap01_chap01_chap01_chap01_chap01_1.7 : What is a clinical trial?1-4
  • Q chap01_1.8 : What is an IRB?1-4
  • Q chap01_1.9 : What is an NDA?1-5
  • Q chap01_1.10 : What is a BLA?1-5
  • Q chap01_chap01_chap01_chap01_1.11 : What is an ANDA?1-5
  • Q chap01_1.12 : What is a 351(k) application?1-5
  • Q chap01_1.13 : What is a 505(b)(2) application?1-5
  • Q chap01_1.14 : What is a generic drug?1-6
  • Q chap01_1.15 : What is a biosimilar product?1-6
  • Q chap01_1.16 : How does the 21st Century Cures Act address drug development in relation to the current FDA procedures for pre- and post-approval FDA regulation?1-6
  • : FDA’s Enforcement Authority1-7
  • Q chap01_1.17 : What is the source of FDA’s enforcement authority with respect to drugs and biologics?1-7
    • Q chap01_1.17.1 : What is the source of FDA authority with respect to drugs pre-approval?1-7
    • Q chap01_1.17.2 : What is the source of FDA authority with respect to drugs post-approval?1-7
  • Q chap01_1.18 : What is the rationale behind FDA enforcement?1-8
  • : Pre-Approval Regulation1-8
  • Q chap01_1.19 : What approval does FDA require for the permissible sale of innovator drugs?1-8
  • Q chap01_chap01_chap01_chap01_1.20 : How does a manufacturer obtain FDA approval to sell an innovator drug?1-8
    • Q chap01_1.20.1 : What is the research process involved in seeking approval for an innovator drug?1-9
    • Q chap01_1.20.2 : What are the phases of clinical testing that lead to approval?1-10
    • Q chap01_1.20.3 : When is IRB approval necessary?1-11
    • Q chap01_1.20.4 : Who conducts the clinical trials?1-12
    • Q chap01_1.20.5 : What are a sponsor’s and investigator’s responsibilities in conducting a clinical trial?1-12
    • Q chap01_chap01_chap01_chap01_1.20.6 : What registration requirements apply to clinical trials?1-14
    • Q chap01_1.20.7 : What are the standards of approval for an NDA?1-15
    • Q chap01_1.20.8 : What is the “substantial evidence” standard?1-16
    • Q chap01_1.20.9 : How does the Cures Act seek to expand the type of data that may be submitted in support of pharmaceutical development?1-17
    • Q chap01_1.20.10 : What are fast track, breakthrough therapy, accelerated approval, and priority review?1-18
    • Q chap01_1.20.11 : Under what circumstances is a 505(b)(2) application appropriate?1-19
  • Q chap01_1.21 : What approval does FDA require for the sale of generic drugs?1-20
  • Q chap01_1.22 : How does a manufacturer obtain FDA approval to sell a generic drug?1-20
  • Q chap01_1.23 : How does a manufacturer obtain FDA approval to sell a biologic?1-21
    • Q chap01_1.23.1 : How does a manufacturer obtain FDA approval to sell a biosimilar product?1-21
  • Q chap01_1.24 : How does FDA communicate its approval decisions?1-22
  • : Post-Approval Regulation1-22
  • Q chap01_1.25 : What post-approval acts can FDA require a manufacturer to undertake?1-22
  • Q chap01_1.26 : When does FDA reconsider or withdraw approval of a drug?1-23
  • Q chap01_1.27 : How does FDA regulate manufacturing practices?1-24
  • Q chap01_1.28 : What drug-related communications does FDA regulate?1-25
    • Q chap01_1.28.1 : What is a drug’s labeling?1-26
    • Q chap01_1.28.2 : What standards and prohibitions apply to labeling?1-26
    • Q chap01_1.28.3 : What is a drug’s advertising?1-27
    • Q chap01_1.28.4 : What standards and prohibitions apply to advertisements?1-27
    • Q chap01_1.28.5 : How does FDA regulate drug promotion?1-28
    • Q chap01_1.28.6 : What is off-label promotion?1-29
  • Q chap01_1.29 : What are FDA’s formal enforcement tools?1-29
  • : FDA Regulation Generally1-30
  • Q chap01_1.30 : How does FDA communicate its enforcement policies and priorities, as well as guidance on compliance?1-30
  • Q chap01_1.31 : What FDA divisions perform enforcement activities?1-31
  • Q chap01_1.32 : When does FDA collaborate with other agencies to meet enforcement objectives?1-32
  • : The 21st Century Cures Act and Its Potential Impact on the FDA Regulatory Process1-32
  • Q chap01_1.34 : How are various drug development tools addressed in the Cures Act?1-33
  • Q chap01_1.35 : How will acceptable clinical trial designs change under the Cures Act?1-34
  • Q chap01_1.36 : What role will “real-world evidence” assume under the Cures Act?1-34
  • Q chap01_1.37 : What is the definition and scope of a “qualified data summary”?1-35
  • Q chap01_1.38 : How does the Cures Act address the issue of “expanded access”?1-35
  • Q chap01_1.39 : What are some forthcoming developments related to the Cures Act?1-36
Chapter 2: FDA Enforcement—Facility Inspections
  • : FDA Inspection Basics2-2
  • Q 2.1 : What does FDA inspect?2-2
  • Q 2.2 : When does/can FDA inspect an establishment/firm/company?2-2
  • Q 2.3 : What are the types of inspection?2-3
  • Q 2.4 : Can the company refuse an inspection?2-3
  • : The Inspection2-3
  • Q 2.5 : How should an onsite inspector visit be handled?2-3
  • Q 2.6 : Who does FDA see—Legal, Quality, or Management?2-4
  • Q 2.7 : What documentation is subject to inspection?2-5
    • Q 2.7.1 : How should a company handle an inspector request to review records that are not subject to inspection?2-5
  • Q 2.8 : Does the company have to provide deviations, change controls, complaints, and rejected batches in an electronic format rather than just paper?2-5
    • Q 2.8.1 : Does the company have to grant FDA access to “live” demos of their systems?2-5
  • 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?2-6
    • 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?2-6
  • Q 2.10 : How should a company handle an inspector whose questions are outside the scope of the inspection?2-6
    • Q 2.10.1 : If an adversarial relationship develops during an inspection, is there an opportunity to replace the inspector?2-6
    • Q 2.10.2 : Does a company have the right to refuse permission to take photographs during an inspection?2-7
  • : Post-Inspection2-7
  • Q 2.11 : What are the possible results of an inspection?2-7
    • Q 2.11.1 : If the company disagrees with an observation, or believes it is incorrectly stated, what are the company’s options?2-8
  • Q 2.12 : Why are U.S. firms inspected without notice?2-9
  • : Non-FDA Regulations2-10
  • 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?2-10
  • : Foreign Complaints2-10
  • Q 2.14 : Can FDA enforce compliance on a company for issues/complaints that did not originate in the United States?2-10
Chapter 3: 483s and Warning Letters
  • : Form FDA 4833-2
  • : FDA Inspections3-2
  • Q 3.1 : What is an FDA inspection?3-2
  • Q 3.2 : Are FDA inspections subject to prior notification?3-3
  • : Form FDA 483 Basics3-3
  • Q 3.3 : What is an FDA Form 483?3-3
  • Q 3.4 : Are FDA observations in a 483 necessarily violations?3-4
  • Q 3.5 : When will my firm receive a 483?3-4
  • Q 3.6 : What are the elements of a 483?3-4
  • : Avoiding, Correcting, and Annotating 483 Observations3-6
  • Q 3.7 : What should be done to avoid observations in a 483?3-6
  • Q 3.8 : What should be done at a close-out meeting?3-6
  • : Responding to a 4833-7
  • Q 3.9 : How quickly should we respond to a 483?3-7
  • Q 3.10 : Who should be involved in preparing a 483 response?3-8
  • Q 3.11 : Can we sue the Food and Drug Administration in response to a 483?3-8
  • Q 3.12 : What are the elements of a good 483 response?3-8
  • Q 3.13 : What if I don’t understand an observation in a 483?3-11
  • Q 3.14 : When is it appropriate to address personnel issues in a 483 response?3-11
  • 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?3-12
  • Q 3.16 : Who should sign a response to a 483?3-12
  • Q 3.17 : To whom should the 483 response be sent?3-12
  • Q 3.18 : Should proprietary information be included in a 483 response?3-13
  • : Meeting with FDA3-13
  • Q 3.19 : Should we try to meet with FDA after receiving a 483?3-13
  • : Dispute Resolution3-14
  • Q 3.20 : What are the mechanisms for dispute resolution around 483s and Warning Letters?3-14
  • : Establishment Inspection Reports3-14
  • Q 3.21 : What is an Establishment Inspection Report?3-14
  • Q 3.22 : How do I obtain a copy of an EIR for an inspection of my facility?3-15
  • Q 3.23 : Are 483s and EIRs available to the public under the Freedom of Information Act?3-15
  • : Warning Letters3-16
  • : Warning Letter Basics3-16
  • Q 3.24 : What is a Warning Letter?3-16
    • Q 3.24.1 : What is an Untitled Letter?3-16
  • Q 3.25 : Must FDA send a Warning Letter before taking enforcement action?3-17
  • Q 3.26 : What factors increase the likelihood of a Warning Letter?3-18
  • Q 3.27 : How quickly will a Warning Letter be issued after issuance of a 483?3-19
  • Q 3.28 : Can a firm sue FDA in response to a Warning Letter?3-20
  • Q 3.29 : What is the process for issuing a Warning Letter?3-20
  • Q 3.30 : What are the elements of a Warning Letter?3-29
  • : Impact of a Warning Letter3-31
  • Q 3.31 : What impact does a Warning Letter have on a company’s government contracts?3-31
  • Q 3.32 : How quickly should we respond to a Warning Letter?3-31
  • Q 3.33 : What is an appropriate Warning Letter response?3-32
  • Q 3.34 : Who should sign a response to a Warning Letter?3-33
  • Q 3.35 : Are Warning Letters available to the public? What about the recipient’s responses?3-33
  • : FDA Receipt of a Warning Letter Response3-33
  • Q 3.36 : What does FDA do when it receives a response to a Warning Letter?3-33
  • Q 3.37 : What is a “close-out” letter?3-34
Chapter 4: FDA Regulations and Enforcement Actions Relative to Oversight of Advertising and Promotion
  • : FDA Responsibility for Oversight of Advertising and Promotion4-3
  • Q 4.1 : What centers within FDA are responsible for oversight of the advertising and promotion of FDA-regulated medical products?4-3
  • Q 4.2 : What are the responsibilities of these centers?4-3
  • : Controlling Statutes and Regulations4-4
  • : Controlling Law4-4
  • Q 4.3 : What statutes and regulations control pharmaceutical marketing and promotion?4-4
  • : FDA Authority Over Prescription Drug-Related Promotional Material4-4
  • Q 4.4 : What information in prescription drug-related promotional material does FDA control?4-4
  • Q 4.5 : Are promotional materials required to be pre-approved by FDA?4-5
  • Q 4.6 : When must promotional materials be submitted to FDA?4-5
    • Q 4.6.1 : Are there exceptions to the time of submission of promotional materials to FDA?4-5
  • Q 4.7 : How does FDA evaluate whether promotional material is in violation of the FDCA and its regulations?4-6
  • : FDA Treatment of Different Types of Prescription Drug Promotional Material4-7
  • Q 4.8 : How does FDA treat different types of promotional material for prescription drugs?4-7
  • Q 4.9 : What is the difference between the professional label and promotional labeling?4-7
  • Q 4.10 : What is a “reminder advertisement”?4-8
  • Q 4.11 : What is a “help-seeking advertisement”?4-8
  • Q 4.12 : What is a “product claim advertisement”?4-8
    • Q 4.12.1 : What is a “broadcast advertisement”?4-9
    • Q 4.12.2 : What must be included in a broadcast advertisement’s “major statement”?4-9
    • Q 4.12.3 : What must be included in the “brief summary”?4-10
    • Q 4.12.4 : What is a “consumer brief summary”?4-10
    • Q 4.12.5 : How do the requirements for print advertisements differ from broadcast advertisements?4-11
  • : Enforcement Actions4-11
  • Q 4.13 : What are some of the most common grounds for enforcement action by FDA related to promotional materials?4-11
  • Q 4.14 : What actions can the government take regarding improper promotion of pharmaceuticals?4-11
  • Q 4.15 : What is a “Warning Letter”?4-12
    • Q 4.15.1 : Under what circumstances does FDA issue a Warning Letter?4-12
    • Q 4.15.2 : What information is included in a Warning Letter?4-12
  • Q 4.16 : What is an “Untitled Letter”?4-13
  • Q 4.17 : Which FDA offices have authority to issue Warning Letters or Untitled Letters?4-13
  • Q 4.18 : Are Warning Letters and Untitled Letters available to the public?4-14
  • Q 4.19 : How should the recipient of a Warning Letter or Untitled Letter respond?4-14
  • Q 4.20 : How are Warning Letter matters concluded?4-15
  • : FTC4-16
  • Q 4.21 : What is the role of the FTC with respect to advertising of products regulated by FDA?4-16
  • : Bad Ad Program4-16
  • Q 4.22 : What is the “Bad Ad Program”?4-16
  • : Internet and Social Media in the Promotion of FDA-Regulated Products4-17
  • Q 4.23 : What have been some of the recent specific enforcement actions taken in relation to promotion via the Internet?4-17
  • 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?4-18
  • Q 4.25 : What are the top issues facing those interested in the promotion of FDA-regulated products via social media?4-21
  • 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?4-21
Chapter 5: Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers’ Advertising and Promotional Activity
  • : Basics of Pharmaceutical Advertising and Promotion Regulation5-3
  • : Definition of “Promotion” and “Advertising” by a Pharmaceutical Manufacturer5-3
  • Q 5.1 : What is “promotion” and “advertising” by a pharmaceutical manufacturer?5-3
  • : Regulating Federal Agencies5-5
  • : Generally5-5
  • Q 5.2 : Which federal agencies regulate pharmaceutical advertising and promotion?5-5
  • : Food and Drug Administration5-5
  • Q 5.3 : Which offices and centers within FDA regulate pharmaceutical advertising and promotion?5-5
  • Q 5.4 : Does FDA provide guidance to pharmaceutical manufacturers regarding appropriate advertising and promotion?5-6
  • Q 5.5 : What type of enforcement activity does FDA take against pharmaceutical manufacturers for inappropriate advertising and promotion?5-6
  • : Federal Trade Commission5-7
  • Q 5.6 : What is the role of the Federal Trade Commission in regulating pharmaceutical advertising and promotion?5-7
  • Q 5.7 : What powers are provided to the FTC to enforce the FTCA?5-8
  • Q 5.8 : Is there coordination between FDA and the FTC relevant to pharmaceutical advertising and promotion?5-9
  • Q 5.9 : What enforcement activity has the FTC taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?5-9
  • : Department of Justice5-10
  • Q 5.10 : What is the role of the DOJ in regulating pharmaceutical advertising and promotion?5-10
  • Q 5.11 : What is the Federal False Claims Act?5-10
  • Q 5.12 : What are the whistleblower provisions of the Federal False Claims Act?5-11
  • Q 5.13 : Is there coordination between FDA and the DOJ relevant to pharmaceutical advertising and promotion?5-12
  • Q 5.14 : What enforcement activity has the DOJ taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?5-12
  • : DHHS Office of Inspector General5-13
  • Q 5.15 : What is the role of the OIG in regulating pharmaceutical advertising and promotion?5-13
  • Q 5.16 : Does the OIG provide guidance to pharmaceutical manufacturers regarding appropriate advertising and promotion?5-13
  • Q 5.17 : May a pharmaceutical manufacturer report potential noncompliance to the OIG?5-14
  • Q 5.18 : Is there coordination between FDA, DOJ, and OIG relevant to pharmaceutical advertising and promotion?5-16
  • Q 5.19 : What types of enforcement activity are available to the OIG?5-16
    • Q 5.19.1 : What is the OIG administrative power to exclude individuals or entities?5-17
    • Q 5.19.2 : What is a CIA and what does it require?5-18
  • : Regulating State Agencies5-19
  • : Generally5-19
  • Q 5.20 : Which state agencies regulate pharmaceutical advertising and promotion?5-19
  • : State Attorneys General5-19
  • Q 5.21 : What is the role of state attorneys general in regulating pharmaceutical advertising and promotion?5-19
  • Q 5.22 : How do state attorneys general coordinate with federal enforcement authorities related to pharmaceutical advertising and promotion?5-20
  • Q 5.23 : What enforcement activity have state attorneys general taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?5-20
  • : Medicaid Fraud Control Units5-21
  • Q 5.24 : What is the role of the Medicaid Fraud Control Units in regulating pharmaceutical advertising and promotion?5-21
  • Q 5.25 : How do the Medicaid Fraud Control Units coordinate with federal enforcement authorities related to pharmaceutical advertising and promotion?5-22
  • Q 5.26 : What enforcement activity have the Medicaid Fraud Control Units taken in recent years against pharmaceutical manufacturers relevant to advertising and promotion?5-22
  • : Expansion of Federal Law5-23
  • Q 5.27 : How did the Fraud Enforcement and Recovery Act of 2009 (FERA) impact the regulation of pharmaceutical advertising and promotion?5-23
  • Q 5.28 : How did the Patient Protection and Affordable Care Act (PPACA) impact the regulation of pharmaceutical advertising and promotion?5-23
  • : Compliance Considerations and Better Practices for Pharmaceutical Manufacturers5-24
  • Q 5.29 : What are some compliance considerations and better practices for pharmaceutical manufacturers relevant to promotional and advertising activities?5-24
  • Q 5.30 : What are some compliance considerations and better practices related to the code of conduct and written policies and procedures?5-25
  • Q 5.31 : What are some compliance considerations and better practices related to advertising/promotional review?5-25
  • Q 5.32 : What are some compliance considerations and better practices related to compliance monitoring and auditing activities?5-26
Chapter 6: Regulatory and Compliance Implications of Disseminating Medical Information and the Distinction with Off-Label Promotion
  • : Statutory Basis for FDA and Government Oversight6-3
  • Q chap06_6.1 : What is the statutory basis for government action against pharmaceutical manufacturers involving allegations of off-label promotion?6-3
  • Q chap06_6.2 : Are there other statutes that implicate illegal off-label promotion?6-5
  • : Off-Label Activities6-6
  • Q chap06_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?6-6
  • Q chap06_6.4 : What constitutes “Off-Label Prescribing”?6-7
  • Q chap06_6.5 : What activities constitute dissemination of medically relevant and accurate scientific and medical information outside of approved labeling?6-7
  • Q chap06_6.6 : What activities constitute “Off-Label Promotion”?6-8
    • Q chap06_6.6.1 : What are the regulatory implications for companies in the disclosure of clinical trial results?6-12
  • : Social Media and Off-Label Promotion6-13
  • : FDA Case-by-Case Evaluation and Industry-Created Practices6-13
  • Q chap06_6.7 : What is the impact of social media on off-label promotion?6-13
  • : FDA Draft Guidance (2011–2014)6-14
  • Q chap06_6.8 : What guidance has FDA provided relating to the use of social media in a promotional context?6-14
  • Q chap06_6.9 : How does the Draft Guidance address “unsolicited” requests for off-label information?6-16
  • : FDA Draft Guidance Impact on Industry Practice6-17
  • Q chap06_6.10 : What kinds of electronic media usage have the potential for off-label promotion?6-17
  • Q chap06_6.11 : What are some of FDA’s articulated concerns relative to electronic media?6-18
    • Q chap06_6.11.1 : What procedures does FDA recommend a company take in responding to requests made online?6-18
    • Q chap06_6.11.2 : What additional guidance has FDA provided in the context of social media and its impact on regulatory and compliance concerns?6-20
    • Q chap06_6.11.3 : Has FDA issued any additional guidance regarding social media since 2014? Are any anticipated?6-22
    • Q chap06_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?6-23
    • Q chap06_6.11.5 : What is the most recent pronouncement by FDA regarding medical products communication?6-24
  • : Oversight by the Executive Branch, Judicial Branch, and State Governments6-27
  • : Generally6-27
  • Q chap06_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?6-27
  • : Office of Inspector General and Department of Justice6-28
  • Q chap06_6.13 : What have been the results of recent government actions relating to off-label promotions on the pharmaceutical industry?6-28
  • Q chap06_6.14 : What kinds of settlements with pharmaceutical companies has the government been able to secure?6-28
  • Q chap06_6.15 : How will the most recent corporate integrity agreements impact the various functions of pharmaceutical manufacturers?6-48
  • : Judicial System6-51
  • Q chap06_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?6-51
  • : State Actions6-52
  • Q chap06_6.17 : What actions have states taken to address the off-label issue?6-52
Chapter 7: Current Status of the Impact of the First Amendment on Off-Label Promotion
  • : Early First Amendment Challenges and FDA Reaction7-3
  • Q 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?7-3
  • Q 7.2 : Does FDA recognize a public health interest in the dissemination of truthful and non-misleading medical information even if off-label?7-4
  • Q 7.3 : Has FDA provided guidance to manufacturers on the dissemination of off-label information?7-4
  • Q 7.4 : Does FDA Guidance provide a “safe harbor” for a pharmaceutical company in disseminating off-label reprints?7-5
    • Q 7.4.1 : What steps should a pharmaceutical company take to take advantage of the “safe harbor”?7-5
    • Q 7.4.2 : Has FDA updated the Guidance since its release in 2009?7-6
  • : The Caronia Decision7-8
  • Q 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?7-8
  • Q 7.6 : What were the facts of Caronia?7-9
  • Q 7.7 : Why was Caronia’s conviction reversed?7-9
  • Q 7.8 : Does Caronia mean that off-label promotion is legal?7-10
  • : Additional First Amendment Challenges7-10
  • Q 7.9 : What is the current environment for government oversight of the dissemination of off-label medical and scientific information?7-10
  • 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?7-11
  • Q 7.11 : Have courts in the Second Circuit dealt with off-label promotion cases since Caronia was decided?7-13
  • Q 7.12 : What circumstances led to the Amarin litigation?7-14
  • Q 7.13 : What was the outcome of Amarin’s First Amendment challenge?7-15
  • Q 7.14 : What gave rise to Pacira’s suit against FDA?7-15
  • Q 7.15 : How did the court rule on Pacira’s First Amendment argument?7-16
  • Q 7.16 : What do Caronia, Amarin, and Pacira mean for the pharmaceutical industry?7-16
  • Q 7.17 : How has industry responded to these cases?7-17
  • Q 7.18 : Has FDA taken any action to address off-label promotion after these cases?7-19
  • Q 7.19 : What actions did FDA take after conducting the public hearing?7-20
  • Q 7.20 : What does the Consistent Communications Draft Guidance say?7-20
  • Q 7.21 : What is the significance of FDA’s memorandum?7-23
  • Q 7.22 : How does the 21st Century Cures Act impact off-label communications by pharmaceutical companies?7-24
  • Q 7.23 : What is the potential effect of the FDA’s proposed Final Rule regarding the scope of “intended use” on off-label promotion?7-28
  • Q 7.24 : Have any state or federal legislative initiatives been undertaken regarding the issue of off-label promotion?7-29
Chapter 8: Food and Drug Administration Amendments Act of 2007 and the Growth of FDA Enforcement Authority
  • : Post-Market Studies and Post-Market Clinical Trials8-3
  • Q 8.1 : Can prescription drug manufacturers be required to conduct studies or clinical trials of a drug product after its approval?8-3
  • Q 8.2 : Is there a difference between a post-market “study” and a post-market “clinical trial”?8-4
  • Q 8.3 : When is FDA authorized to require post-market studies or post-market clinical trials?8-4
  • Q 8.4 : What is a “serious risk,” a “signal of a serious risk,” and an “unexpected serious risk”?8-5
  • 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?8-6
  • 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?8-6
  • Q 8.7 : What is the process for FDA to require a post-market study or post-market clinical trial under FDAAA?8-7
  • Q 8.8 : How does FDA determine whether post-market studies or post-market clinical trials are proceeding in accordance with the established timetable?8-8
  • Q 8.9 : Are there any penalties for failing to comply with PMR requirements?8-8
  • : Authority to Mandate Safety Labeling Changes8-9
  • Q 8.10 : Can FDA require companies to revise the approved labeling of their marketed drug and biological products?8-9
  • Q 8.11 : Does FDA’s authority to require safety labeling changes apply to all drug and biological products?8-10
  • Q 8.12 : Can FDA order changes to any portion of a covered product’s approved labeling?8-10
  • Q 8.13 : What is the process for FDA to require safety labeling changes?8-11
  • Q 8.14 : If a sponsor intends to propose a safety labeling change, what type of supplement should be submitted?8-12
  • Q 8.15 : Is FDA subject to any deadlines for responding to a sponsor’s supplement or rebuttal statement?8-12
  • Q 8.16 : What happens if FDA and the sponsor cannot agree on labeling language?8-13
  • Q 8.17 : Should the FDAAA process be used if the sponsor, rather than FDA, first becomes aware of “new safety information”?8-14
  • Q 8.18 : Are there penalties for failing to comply with a safety labeling change order?8-15
  • : Risk Evaluation and Mitigation Strategies8-15
  • Q 8.19 : What is a REMS?8-15
  • Q 8.20 : What are the standards for imposing a REMS?8-15
  • Q 8.21 : If FDA decides to impose a REMS, what specific risk management tools can it require to be used?8-16
  • Q 8.22 : Under what circumstances can FDA impose a distribution or use restriction as an ETASU?8-17
  • Q 8.23 : Can a REMS be modified?8-18
  • Q 8.24 : How does FDA process proposed REMS and REMS assessments?8-18
  • Q 8.25 : Do the REMS provisions apply to generic drugs?8-19
  • Q 8.26 : How is a REMS applied when a safety issue affects a class of products?8-20
  • Q 8.27 : Are there penalties for failing to comply with a REMS requirement?8-20
  • : Civil Money Penalties for REMS and Other Post-Market Safety Violations8-20
  • Q 8.28 : Can FDA impose CMPs for violations of the FDAAA provisions discussed above governing post-approval drug safety?8-20
  • : Selected Advertising Provisions of FDAAA8-21
  • : Pre-Review of Television Advertisements8-21
  • Q 8.29 : Can FDA require companies to submit advertisements for review prior to dissemination?8-21
  • Q 8.30 : Can FDA require modifications to television advertisements submitted for pre-review?8-22
  • : Major Statement in Radio and Television Advertisements8-23
  • Q 8.31 : Does FDAAA affect how risk information is communicated in DTC advertisements?8-23
  • Q 8.32 : Has FDA provided guidance on what “clear, conspicuous, and neutral” means?8-23
  • : Other Advertising Provisions8-24
  • Q 8.33 : Did FDAAA include other provisions applicable to drug advertising?8-24
  • : Civil Money Penalties for DTC Advertising Violations8-24
  • Q 8.34 : Can FDA impose CMPs for advertising violations?8-24
  • Q 8.35 : What are the procedures for imposing CMPs for advertising violations?8-25
    • Q 8.35.1 : Has FDA ever used its new authority to impose CMPs for advertising violations?8-25
  • : Clinical Trial Registries and Results Databases8-26
  • : Overview8-26
  • Q 8.36 : Are prescription drug manufacturers subject to requirements for registering clinical trials on a publicly accessible, government database?8-26
  • Q 8.37 : What is the clinical trial registry database?8-26
  • Q 8.38 : What is the clinical trial results database?8-27
  • Q 8.39 : Who is responsible for submitting clinical trial information to CT.gov in accordance with the FDAAA requirements?8-27
  • 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?8-28
  • : Foreign Clinical Studies8-28
  • 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?8-28
  • : Applicable Drug Clinical Trials8-29
  • Q 8.42 : Does information about observational studies need to be submitted to CT.gov?8-29
  • Q 8.43 : If the FDAAA requirements apply, when must a sponsor submit information about a drug trial to the clinical trial registry database?8-29
  • Q 8.44 : What type of information must be submitted to the clinical trial registry for each “applicable drug clinical trial”?8-29
  • : Public Availability of Registry and Results Information8-30
  • Q 8.45 : Does NIH make registry information publicly available at or near the time it is submitted to CT.gov?8-30
  • 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?8-30
  • : Timing of Submissions8-31
  • Q 8.47 : If results information is required, when must it be submitted to CT.gov and by whom?8-31
  • Q 8.48 : Are there any mechanisms to delay the deadline for submission of results information?8-31
  • : Results Information and Reporting Requirements8-32
  • Q 8.49 : If required, what type of results information must be submitted to CT.gov for each applicable drug clinical trial?8-32
  • Q 8.50 : Are sponsors required to update their submissions to CT.gov?8-33
  • Q 8.51 : Are there any state clinical trial reporting requirements?8-33
  • : Compliance and Enforcement8-33
  • Q 8.52 : What are the consequences for failure to comply with the clinical trial reporting requirements under FDAAA?8-33
  • Q 8.53 : How does the government monitor compliance?8-34
Chapter 9: Risk Evaluation and Mitigation Strategies (REMS) and Related Post-Market Safety Oversight
  • : Basics of REMS9-4
  • Q 9.1 : What are REMS? When was that term first introduced?9-4
  • Q 9.2 : How do REMS compare to RiskMAPs?9-5
  • : REMS Development and Oversight9-5
  • Q 9.3 : What is the name of the government entity that handles REMS development and oversight?9-5
  • Q 9.4 : When can a REMS be required and how are REMS for particular products or classes of products devised?9-6
  • Q 9.5 : Are there any advantages to a company proactively suggesting REMS for a particular product to FDA?9-7
  • Q 9.6 : Who within a company is typically involved in devising a REMS plan?9-8
  • Q 9.7 : What are some typical components of REMS?9-9
  • Q 9.8 : Are ANDA holders subject to the same requirements for REMS as NDA holders?9-10
  • Q 9.9 : Are periodic assessments necessary to determine if a REMS is working and if so, how are such assessments typically performed?9-10
  • Q 9.10 : Is there a defined process for modifying or revising approved REMS?9-11
  • : Post-Market Safety Oversight9-12
  • Q 9.11 : Can products with REMS still be subject to market withdrawal or product liability lawsuits by patients alleging harm from such drugs?9-12
  • Q 9.12 : Can a REMS be mandated after a drug is already on the market?9-14
  • Q 9.13 : Are there any penalties for noncompliance with REMS?9-15
  • Q 9.14 : How many REMS programs are currently in place? Where can I find information about a particular product’s REMS?9-15
  • Q 9.15 : Were there drugs approved before FDAAA that were later deemed to have REMS?9-16
  • Q 9.16 : If a drug has a medication guide, does this mean it is subject to REMS?9-16
  • Q 9.17 : What other types of post-market safety oversight exist to monitor drug safety?9-17
  • Q 9.18 : How are spontaneous adverse event reports made? How are physicians and patients given information about how to report adverse events?9-17
  • 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?9-17
  • Q 9.20 : What is a “signal” and how is a signal identified once a drug is being marketed?9-18
  • 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?9-19
  • Q 9.22 : What challenges exist for generic drug companies when seeking to introduce products that are subject to a REMS?9-19
  • Q 9.23 : What other measures should be considered if a company adopts a REMS?9-21
  • Q 9.24 : What other initiatives exist with respect to REMS?9-21
  • Q 9.25 : 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?9-22
  • Q 9.26 : 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?9-23
  • Q 9.27 : What further guidance can we expect from FDA about REMS requirements?9-24
Chapter 10: Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers
  • : Oversight of the Pharmaceutical Industry10-3
  • Q chap10_10.1 : What is FDA’s regulatory regime applicable to drug manufacturers?10-3
  • Q chap10_10.2 : How does FDA regulatory regime impact state product liability claims against drug manufacturers?10-3
  • Q chap10_10.3 : Is oversight of the pharmaceutical industry limited to FDA regulations and authority?10-5
  • : State Law Tort Claims10-6
  • : Generally10-6
  • Q chap10_10.4 : What type of state law tort claims can be asserted against drug manufacturers by consumers of their drugs?10-6
  • : Drug Manufacturers Failure to Warn10-6
  • Q chap10_10.5 : What are the general standards for a failure to warn claim in the prescription drug context?10-6
    • Q chap10_10.5.1 : What is the “learned intermediary doctrine”?10-8
  • : Manufacturers Drug Labeling10-10
  • Q chap10_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?10-10
  • Q chap10_10.7 : How does FDA define a “label”?10-10
  • Q chap10_10.8 : Is the brand-name manufacturer responsible for updating drug labels under the FDCA?10-12
    • Q chap10_10.8.1 : What is the effect of manufacturer responsibility for updating drug labels on state product liability law?10-13
  • Q chap10_10.9 : Is the generic manufacturer’s responsibility for updating drug labels different from the brand-name manufacturer?10-14
  • Q chap10_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?10-15
  • : FDA Preemption of State Law10-17
  • Q chap10_10.11 : Does the FDCA preempt state law product liability claims against brand-name drug manufacturers and generic drug manufacturers?10-17
  • Q chap10_10.12 : What is “implied preemption” and how have the courts applied the doctrine to ban claims against drug manufacturers?10-19
  • : Brand-Name Manufacturer Liability10-21
  • Q chap10_10.13 : Can the brand-name manufacturer be held liable when the plaintiff purchased the product from the generic manufacturer?10-21
  • : Design Defect Claims10-22
  • Q chap10_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?10-22
  • : Fraud and Negligence Claims10-23
  • Q chap10_10.15 : Are claims for fraud and negligence impliedly preempted?10-23
  • : Risk Management Developments10-25
  • Q chap10_10.16 : How have the recent developments in risk management affected product liability for pharmaceutical manufacturers?10-25
  • Q chap10_10.17 : What risk management tool does FDA use?10-26
  • : FDA and OIG Oversight of Product Liability Exposures10-28
  • Q chap10_10.18 : What role does FDA and OIG oversight play relative to product liability exposure?10-28
  • Q chap10_10.19 : Can allegations of off-label promotional activity serve as the basis of a qui tam action under the False Claims Act?10-30
  • Q chap10_10.20 : What is the potential impact of the FDA Draft Guidance Relating to “Emerging Signals” on Pharmaceutical Manufacturer Liability?10-30
Chapter 11: Specific FDA Enforcement Tools
  • : Warning Letters11-2
  • Q 11.1 : What is a Warning Letter?11-2
  • Q 11.2 : What is the source of FDA’s authority to issue a Warning Letter?11-3
  • Q 11.3 : What violations of the FDCA can prompt the issuance of a Warning Letter by FDA?11-3
  • Q 11.4 : Are there circumstances where a Warning Letter will not be issued prior to an FDA enforcement action?11-4
  • Q 11.5 : How long does a company have to respond to a Warning Letter?11-4
  • Q 11.6 : Are Warning Letters available to the public?11-5
  • Q 11.7 : What is a Warning Letter close-out letter?11-5
  • : Product Recalls11-6
  • Q 11.8 : What is a product recall?11-6
  • Q 11.9 : Does FDA have statutory authority to order a product recall?11-6
  • Q 11.10 : Under what circumstances can FDA order the recall of medical devices and biologics?11-6
  • Q 11.11 : Can FDA request that a company conduct a voluntary recall?11-7
  • Q 11.12 : When a company voluntarily implements a recall, what are the responsibilities of the company and FDA?11-8
  • Q 11.13 : What is a health hazard evaluation?11-11
  • Q 11.14 : What are the different recall classifications?11-11
  • Q 11.15 : What are the differences among a recall, market withdrawal and stock recovery?11-12
  • Q 11.16 : When is a recall considered complete?11-13
  • : Import Detentions and Alerts11-13
  • Q 11.17 : What is an import detention?11-13
  • Q 11.18 : What is an import alert?11-14
  • : Product Seizures11-15
  • Q 11.19 : What is a product seizure?11-15
  • Q 11.20 : What is the source of FDA’s authority to seize products?11-15
  • Q 11.21 : Are there different types of seizures that FDA can implement?11-15
  • Q 11.22 : Under what circumstances may FDA seize a product?11-16
  • Q 11.23 : Can FDA take possession of a product before a seizure action is filed?11-16
  • Q 11.24 : What is FDA’s process for seizing products?11-17
  • Q 11.25 : What must a company do to contest a product seizure?11-17
  • Q 11.26 : Are there any requirements attendant to an amicable resolution of a seizure action?11-18
  • : Injunctive Relief11-18
  • Q 11.27 : May FDA obtain injunctive relief against a company?11-18
  • Q 11.28 : Under what circumstances may FDA seek an injunction?11-19
  • Q 11.29 : Can FDA obtain injunctive relief before it affords a company notice and a hearing?11-19
  • Q 11.30 : What standard must FDA meet to obtain a preliminary injunction?11-20
  • Q 11.31 : What types of injunctions may FDA seek?11-21
  • : Civil Money Penalties11-21
  • Q 11.32 : What is a civil money penalty?11-21
  • Q 11.33 : Under what circumstances may FDA impose a CMP, and under what legal authority?11-21
  • Q 11.34 : May FDA impose a CMP against individuals within a company that committed a violation?11-23
  • Q 11.35 : How does FDA impose a CMP?11-23
  • Q 11.36 : Are there exceptions to the FDCA’s broad authority to impose CMPs on a medical device manufacturer?11-24
  • Q 11.37 : Are there limits on FDA’s authority to impose a CMP on drug manufacturers?11-24
  • Q 11.38 : What factors does FDA consider in determining the amount of a CMP against a medical device company?11-25
  • 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?11-26
  • : Clinical Trial Penalties11-27
  • Q 11.40 : What is a clinical trial penalty?11-27
  • Q 11.41 : What is the source of FDA’s authority to impose clinical trial penalties?11-27
  • Q 11.42 : What types of violations will prompt FDA to impose a clinical trial penalty?11-27
  • Q 11.43 : Does FDA have the authority to disqualify a clinical trial investigator?11-27
  • Q 11.44 : What procedures does FDA follow to disqualify a clinical trial investigator?11-28
  • Q 11.45 : What is a clinical hold letter?11-29
  • Q 11.46 : Under what circumstances can FDA issue a clinical hold letter?11-29
  • Q 11.47 : How much time does the company have to respond to a clinical hold letter?11-29
  • Q 11.48 : How much time does FDA have to take further action after receiving the company’s response to a clinical hold letter?11-30
  • Q 11.49 : Under what circumstances may FDA terminate a clinical investigation?11-30
  • : Criminal Penalties11-30
  • Q 11.50 : Under what authority are criminal prosecutions for violations of the FDCA authorized?11-30
  • Q 11.51 : Under what circumstances does the FDCA impose criminal liability on corporate executives?11-31
  • : Withdrawal of Approval11-31
  • Q 11.52 : Can FDA withdraw its approval of a new drug or medical device application?11-31
  • Q 11.53 : What is the source of FDA’s authority to withdraw approval of a product?11-32
  • Q 11.54 : Under what circumstances will FDA withdraw its approval of a new drug application?11-32
  • Q 11.55 : Under what circumstances will FDA withdraw its approval of a medical device application?11-33
  • Q 11.56 : What is the process FDA must follow to withdraw approval?11-33
  • Q 11.57 : Can FDA withdraw approval of a product indication?11-34
  • : Some Special Enforcement Issues11-34
  • Q 11.58 : What is FDA’s authority to combat the importation of counterfeit and unapproved drugs?11-34
  • Q 11.59 : What enforcement actions has FDA taken against manufacturers and sellers of counterfeit and unapproved drugs?11-35
  • Q 11.60 : What enforcement actions may FDA take against compounding pharmacies?11-35
  • Q 11.61 : What enforcement actions may FDA take against manufacturers of tobacco products?11-36
  • Q 11.62 : What are FDA’s enforcement powers for genetically modified foods?11-36
  • Q 11.63 : What are FDA’s enforcement powers to enforce preventative food safety requirements?11-37
  • Q 11.64 : What are FDA’s enforcement powers with respect to stem cell therapies and regenerative medicine?11-37
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 Agencies12-3
  • Q 12.1 : What roles do FDA’s Office of Criminal Investigations and other governmental agencies play in FDA criminal enforcement?12-3
  • Q 12.2 : What is the structure and role of FDA’s Office of Criminal Investigations?12-4
  • Q 12.3 : What efforts has FDA undertaken to improve the Office of Criminal Investigations?12-6
  • Q 12.4 : What role does the U.S. Department of Justice play in prosecuting criminal violations of statutes within FDA’s purview?12-7
  • 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?12-7
  • Q 12.6 : How does FDA collaborate with other agencies on criminal investigations?12-9
  • : FDA Criminal Investigations12-11
  • Q 12.7 : How does the Office of Criminal Investigations conduct its investigations?12-11
  • Q 12.8 : What subpoena powers may the government invoke when investigating offenses within FDA’s purview?12-12
  • Q 12.9 : How do routine FDA inspections intersect with FDA’s criminal enforcement goals?12-14
  • : Federal Criminal Charges12-14
  • : Prerequisites for Filing Charges12-14
  • Q 12.10 : When does an FDA investigation result in criminal charges?12-14
  • : FDA’s Determination to Pursue Criminal Prosecution12-15
  • Q 12.11 : How does FDA determine whether to recommend criminal charges?12-15
    • Q 12.11.1 : What is a section 305 notice under the FDCA?12-15
    • Q 12.11.2 : What factors does the Office of Criminal Investigations consider in determining whether to recommend criminal charges?12-16
  • : DOJ’s Willingness to Bring Charges12-16
  • 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?12-16
  • Q 12.13 : What individuals will federal prosecutors target for violations of the FDCA?12-18
  • Q 12.14 : How do federal prosecutors decide whether to bring criminal charges against a corporate entity?12-20
  • Q 12.15 : What tools can federal prosecutors use to settle criminal charges against corporations?12-22
  • : Federal Criminal Statutes Jointly Enforced by FDA and the DOJ12-25
  • : Generally12-25
  • Q 12.16 : What federal criminal statutes does FDA enforce with DOJ’s assistance?12-25
  • : FDCA Provisions Giving Rise to Criminal Liability12-26
  • Q 12.17 : What conduct does the FDCA proscribe and what are the consequences for engaging in such conduct?12-26
  • Q 12.18 : What constitutes “adulteration” under the FDCA?12-26
  • Q 12.19 : What constitutes “misbranding” under the FDCA?12-27
    • Q 12.19.1 : What guidance has FDA provided regarding misbranding and social media?12-27
  • Q 12.20 : What other conduct does the FDCA proscribe?12-29
  • Q 12.21 : Are violations of the FDCA misdemeanors or felonies?12-30
  • : Park Doctrine12-30
  • Q 12.22 : Is criminal intent an element of FDCA charges?12-30
  • Q chap12_12.22 : How did the Park doctrine originate?12-31
  • Q 12.24 : What guidelines has FDA established with regard to the Park doctrine?12-33
  • Q 12.25 : Who can be convicted under the Park doctrine?12-33
  • Q 12.26 : What conduct might give rise to corporate criminal liability?12-36
  • : Defenses to FDCA Charges12-37
  • Q 12.27 : What defenses are available to charges under the FDCA?12-37
  • Q 12.28 : What must a defendant show to invoke the FDCA’s statutory defenses?12-37
  • Q 12.29 : What must a defendant show to invoke defenses to a Park doctrine FDCA prosecution?12-38
  • : Criminal Penalties for FDCA Violations12-39
  • Q 12.30 : What criminal penalties could be imposed under the FDCA?12-39
  • : Collateral Consequences That May Accompany an FDCA Conviction12-40
  • Q 12.31 : What collateral consequences are possible under the FDCA and related laws?12-40
  • : Criminal and Civil Liability12-41
  • Q 12.32 : How does criminal liability under the FDCA intersect with civil liability under the False Claims Act?12-41
  • : Anti-Tampering Act and Other Offenses Under Title 18 of the U.S. Code12-42
  • Q 12.33 : What other federal statutes does FDA’s OCI investigate?12-42
  • Q 12.34 : What conduct does the Federal Anti-Tampering Act prohibit?12-42
  • Q 12.35 : What criminal penalties may be imposed for a conviction for violating the Federal Anti-Tampering Act?12-44
  • Q 12.36 : What other statutory offenses may be within FDA’s purview?12-44
Chapter 13: Pharmaceutical Price Reporting: The “ABCs” and “123s” of Compliance
  • : Federal Prescription Drug Programs: Pricing and Reporting Requirements13-3
  • : Medicaid Drug Rebate Program (MDRP)13-3
  • Q 13.1 : What is Medicaid?13-3
  • Q 13.2 : What is the MDRP?13-4
  • Q 13.3 : Who is a “manufacturer” under the MDRP?13-4
  • Q 13.4 : What does the MDRP require of pharmaceutical manufacturers?13-4
  • Q 13.5 : Have there been recent modifications to the MDRP pricing metrics?13-6
  • Q 13.6 : Without clear MDRP regulatory guidance, what have been some issues confronted by pharmaceutical manufacturers in their AMP and BP pricing calculations?13-8
  • Q 13.7 : Has CMS Issued a Final Rule?13-11
  • : 340B Drug Discount Program (“340B Program”)13-20
  • Q 13.8 : What is the 340B Program?13-20
  • Q 13.9 : What does the 340B Program require of pharmaceutical manufacturers?13-21
  • Q 13.10 : Are 340B covered entities subject to any restrictions?13-21
  • Q 13.11 : How do 340B covered entities acquire drugs at the 340B price?13-22
  • Q 13.12 : Are 340B covered entities restricted on the number of its contract pharmacies?13-22
  • Q 13.13 : Have there been developments over time affecting the 340B Program?13-22
  • Q 13.14 : What key topics are addressed in the proposed omnibus guidance for the 340B program?13-30
  • : Department of Veterans Affairs (VA) Drug Discount Program13-33
  • Q 13.15 : What is the VA drug discount program?13-33
  • Q 13.16 : What does the VA drug discount program require of pharmaceutical manufacturers?13-33
  • Q 13.17 : What kind of pharmaceutical products are covered under the VA drug discount program?13-35
  • Q 13.18 : Are pharmaceutical manufacturers subject to other associated programs for veterans or other military personnel?13-36
  • : Medicare Part B: Average Sales Price13-37
  • Q 13.19 : What is Medicare?13-37
  • Q 13.20 : What kinds of drugs are covered by Part B?13-37
  • Q 13.21 : What is the Part B prescription drug reimbursement procedure?13-38
    • Q 13.21.1 : What is the ASP and how is it calculated?13-38
  • : Government Program Pricing and Reporting: Compliance Risks13-40
  • : Generally13-40
  • Q 13.22 : What are the repercussions to a pharmaceutical manufacturer who does not comply with federal healthcare program pricing and reporting obligations?13-40
  • : CMPs and Administrative Sanctions13-40
  • Q 13.23 : What noncompliance penalties are assessed by the MDRP?13-40
  • : Federal False Claims Act (FCA)13-44
  • Q 13.24 : What is the FCA?13-44
  • Q 13.25 : What do the terms “knowing” and “knowingly” mean under the FCA?13-44
  • Q 13.26 : What are the penalties for violation of the FCA?13-45
  • Q 13.27 : Has there been litigation involving government price reporting under the FCA?13-45
Chapter 14: The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry
  • : FCPA Basics14-3
  • Q 14.1 : What FCPA basics should the pharmaceutical industry know?14-3
  • Q 14.2 : Which U.S. regulators enforce the FCPA?14-3
  • Q 14.3 : Who is covered by the FCPA?14-4
  • Q 14.4 : What do the FCPA’s anti-bribery provisions prohibit?14-5
  • Q 14.5 : Does the FCPA contain any affirmative defenses?14-6
  • Q 14.6 : Does the FCPA contain any exceptions?14-7
  • Q 14.7 : What do the FCPA’s accounting provisions require?14-7
  • Q 14.8 : What fines and penalties may be assessed for FCPA violations?14-7
  • Q 14.9 : What collateral consequences might arise from an FCPA violation?14-8
  • Q 14.10 : What other laws are used in conjunction with the FCPA?14-9
  • : Anti-Bribery Provisions in Detail14-10
  • : Anything of Value14-10
  • Q 14.11 : What does the phrase “anything of value” mean?14-10
  • Q 14.12 : How have cash and cash equivalents featured in FCPA actions?14-10
  • Q 14.13 : Are travel and entertainment considered “anything of value”?14-11
  • Q 14.14 : Are gifts considered “anything of value”?14-12
  • Q 14.15 : Are sponsorships and trainings considered “anything of value”?14-13
  • Q 14.16 : Are clinical trials and observational studies considered “anything of value”?14-13
  • Q 14.17 : Are employment and/or consulting agreements considered “anything of value”?14-14
  • Q 14.18 : Are charitable donations considered “anything of value”?14-15
  • : Third Parties14-16
  • Q 14.19 : How do third parties pose FCPA risks?14-16
  • Q 14.20 : Do joint venture partners pose FCPA risks?14-17
  • Q 14.21 : Do local agents and consultants pose FCPA risks?14-18
  • Q 14.22 : Do distributors present unique FCPA risks?14-19
  • Q 14.23 : Are there FCPA risks associated with travel agents and conference organizers?14-20
  • Q 14.24 : Do medical foundations and societies present FCPA risks?14-21
  • : Foreign Officials14-22
  • Q 14.25 : What is a “foreign official” for purposes of the FCPA?14-22
  • Q 14.26 : Are HCPs foreign officials?14-22
  • Q 14.27 : Are pharmacists foreign officials?14-23
  • Q 14.28 : Are laboratory technicians foreign officials?14-23
  • Q 14.29 : Are hospital administrators and employees foreign officials?14-23
  • Q 14.30 : Are healthcare regulators foreign officials?14-23
  • : Corrupt Intent14-24
  • Q 14.31 : When are offers, promises, authorizations, or payments made corruptly?14-24
  • : Business Purpose14-25
  • Q 14.32 : What does it mean to obtain or retain business?14-25
  • : Accounting Provisions in Detail14-25
  • : In General14-25
  • Q 14.33 : What do the accounting provisions require?14-25
  • : Books and Records14-25
  • Q 14.34 : What is the books and records provision?14-25
  • : Internal Controls14-26
  • Q 14.35 : What is the internal controls provision?14-26
  • : Successor Liability14-27
  • Q 14.36 : Does an acquiring company assume a target’s liability under the FCPA’s anti-bribery provisions?14-27
  • Q 14.37 : What limitations are there on successor liability?14-28
  • Q 14.38 : What can an acquiring company do to protect itself from successor liability?14-28
  • : Mitigating FCPA Risk and Anti-Corruption Compliance Programs14-29
  • Q 14.39 : How can effective anti-corruption compliance programs help companies mitigate FCPA risk?14-29
  • Q 14.40 : What does the government expect to see in an anti-corruption compliance program?14-30
  • Q 14.41 : What additional requirements have pharmaceutical companies agreed to include in their anti-corruption compliance programs when settling with the government?14-33
  • Q 14.42 : Do expectations for compliance programs vary depending on the jurisdiction and relevant government enforcement agency?14-34
  • Q 14.43 : How can industry codes inform anti-corruption compliance programs?14-34
  • Q 14.44 : How can companies mitigate FCPA risk when engaging third parties?14-35
    • Q 14.44.1 : What additional considerations are there when engaging and working with a distributor?14-36
    • Q 14.44.2 : What additional considerations are there when engaging an HCP?14-37
  • Q 14.45 : How can companies mitigate the FCPA risk associated with meals, gifts, and travel?14-38
Chapter 15: Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act
  • : Corporations–Federal Legal Consequences–Administrative15-2
  • : The FDA Application Integrity Policy (AIP)15-2
  • Q 15.1 : What is the Application Integrity Policy (AIP)?15-2
  • Q 15.2 : What triggers FDA imposing the AIP?15-3
  • Q 15.3 : What does FDA expect a firm on the AIP to do to resolve FDA concerns about the reliability of the sponsor’s data to get off the AIP list?15-3
  • Q 15.4 : How often has the AIP been imposed on a company and for how long?15-4
  • : Generic Drug Enforcement Act of 1992 and Corporations15-4
  • Q 15.5 : What is the Generic Drug Enforcement Act of 1992?15-4
  • Q 15.6 : What is corporate debarment under the GDEA?15-4
    • Q 15.6.1 : When is corporate debarment mandatory?15-5
    • Q 15.6.2 : When may FDA impose “permissive” debarment on a corporation?15-5
    • Q 15.6.3 : How many times has FDA debarred a corporation under the GDEA?15-5
  • : Suspension and Debarment of Drug Companies from Federal Government Contracting15-6
  • Q 15.7 : Why would a drug company be concerned about suspension or debarment of its ability to contract with the federal government?15-6
  • Q 15.8 : What is a suspension?15-6
  • Q 15.9 : What are grounds for suspension of a government contractor?15-6
  • Q 15.10 : How does debarment differ from suspension?15-7
  • Q 15.11 : What are the grounds for debarment?15-8
  • Q 15.12 : How long can debarment last?15-8
  • Q 15.13 : Is suspension or debarment punitive?15-9
  • : Exclusion from Federal Healthcare Programs15-9
  • Q 15.14 : What is exclusion from healthcare programs?15-9
  • Q 15.15 : What are the criteria for exclusion for entities?15-9
    • Q 15.15.1 : What are the criteria for mandatory exclusion for entities?15-9
    • Q 15.15.2 : What are the criteria for permissive exclusion for entities?15-10
  • : State Manufacturing License Suspension or Revocation15-11
  • Q 15.16 : Can a state deny or revoke a drug firm’s manufacturing license (or application for license) due to an FDCA conviction?15-11
  • : Other Potential Legal Consequences for Corporations of FDCA and Related Convictions15-12
  • Q 15.17 : For publicly traded drug companies, what civil litigation is likely to be spawned by an indictment or conviction of FDCA violations?15-12
  • Q 15.18 : Can criminal convictions lead to loss of financial agreements such as mortgages and bank loans?15-13
  • Q 15.19 : What other adverse consequences of a legal or business nature might a drug company face when dealing with criminal violations?15-13
  • : Individuals—Collateral Consequences of Criminal Violations of the FDCA15-14
  • : Generic Drug Enforcement Act Debarment15-14
  • Q 15.20 : When is mandatory debarment of an individual required under the GDEA?15-14
  • Q 15.21 : Under what circumstances is an individual subject to permissive debarment under the GDEA?15-14
  • Q 15.22 : How long can individual debarment last?15-15
  • : Individuals—Exclusion from Federal Healthcare Programs15-16
  • Q 15.23 : What are the criteria for exclusion of individuals from federal healthcare programs?15-16
  • Q 15.24 : Can an individual who pleads guilty under the Park Doctrine as a responsible corporate official, but denies intentional or knowing violations, be excluded under 42 U.S.C. § 1320a-7?15-16
  • : Clinical Investigator Disqualification15-17
  • Q 15.25 : Can FDCA criminal charges also occur in conjunction with disqualification of clinical investigators?15-17
  • : Imprisonment and Fines for Crimes15-17
  • Q 15.26 : What are the potential fines and prison/jail sentences for individuals for an FDCA violation?15-17
  • : Right to Vote15-18
  • Q 15.27 : Can an individual lose their right to vote if convicted of a FDCA violation?15-18
  • : Eligibility to Run for Public Office15-18
  • Q 15.28 : Can a convicted felon run for public office?15-18
  • : Deportation15-18
  • Q 15.29 : Can a non-U.S. citizen be deported if convicted of an FDCA violation?15-18
    • Q 15.29.1 : Does the offense have to be a felony?15-19
  • : Loss of Other Rights/Privileges15-19
  • Q 15.30 : What other rights or privileges can an individual lose due to a criminal conviction?15-19
Chapter 16: Prescription Drug Sampling Regulation and Enforcement
  • : An Overview of Prescription Drug Sampling16-3
  • Q 16.1 : What is prescription drug sampling and why is it so common?16-3
  • : Prescription Drug Sampling: The Legal and Regulatory Landscape16-4
  • Q 16.2 : What laws are implicated by prescription drug sampling?16-4
  • Q 16.3 : Why did Congress enact the PDMA?16-6
  • Q 16.4 : What does the PDMA require with respect to drug sampling?16-7
  • Q 16.5 : Who regulates prescription drug sampling?16-9
  • : PDMA and Sampling Enforcement and Litigation16-10
  • Q 16.6 : What guidance have federal regulators provided regarding compliance with laws governing prescription drug sampling?16-10
  • Q 16.7 : What guidance have industry groups and non-profit organizations provided regarding compliance with laws governing prescription drug sampling?16-14
  • Q 16.8 : How have regulators enforced the laws governing prescription drug sampling?16-15
  • Q 16.9 : How have the federal courts handled claims invoking the PDMA?16-16
Chapter 17: The 21st Century Cures Act: Overview and Impact on Product Development and the U.S. Food & Drug Administration
  • : Introduction17-2
  • Q 17.1 : What was the 21st Century Cures Act Initiative?17-2
  • Q 17.2 : When was the 21st Century Cures Act enacted?17-2
  • : Overview of Significant Cures Act Provisions Impacting FDA17-2
  • : Research Funding17-2
  • Q 17.3 : What does the Cures Act do to support research and the discovery of new therapies?17-2
  • : Pharmaceutical Development and Review17-3
  • Q 17.4 : How does the 21st Century Cures Act support the Patient-Focused Drug Development Initiative?17-3
  • Q 17.5 : How does the 21st Century Cures Act support the qualification of drug development tools?17-4
  • Q 17.6 : How does the Cures Act support the development of drugs and biologics for rare diseases?17-5
  • Q 17.7 : How does the Cures Act support continuous manufacturing?17-5
  • Q 17.8 : What does the Cures Act do to modernize trial design and evidence development?17-6
  • Q 17.9 : How does the Cures Act advance the use of real world evidence to support regulatory decision-making?17-6
  • Q 17.10 : How does the Cures Act streamline the clinical data that product sponsors must submit to support the approval of a new indication of an already approved drug?17-7
  • Q 17.11 : What is Expanded Access, and how is it addressed in the Cures Act?17-7
  • Q 17.12 : How does the Cures Act advance regenerative medicine therapies?17-8
  • Q 17.13 : How does the Cures Act support the development of antimicrobial therapies?17-9
  • : Medical Device Development and Review17-9
  • Q 17.14 : What is the Breakthrough Device pathway?17-9
  • Q 17.15 : What is the Humanitarian Device exemption, and how did the Cures Act expand the exemption?17-10
  • Q 17.16 : How does the Cures Act advance least burdensome review of medical devices?17-10
  • Q 17.17 : Which types of medical software are regulated as medical devices?17-11
  • : Other Provisions17-11
  • Q 17.18 : What are combination products, and does the Cures Act impact the process under which such products are reviewed?17-11
  • Q 17.19 : How does the Cures Act advance the development and availability of Medical Countermeasures?17-12
  • Q 17.20 : How does the Cures Act support the coordination between FDA’s product review centers?17-13
  • Q 17.21 : Does the Cures Act address the dissemination of healthcare economic information?17-13
  • Q 17.22 : Other than the medical innovation provisions, what other policies are in the Cures Act?17-14
  • : Current Status and Implementation17-15
  • Q 17.23 : Has FDA started implementing the Cures Act?17-15
  • Q 17.24 : How can I track the status of FDA’s implementation of the Cures Act?17-15
  Index
Share
Email
UPKEEP SERVICE
Your purchase will also sign you up for “Upkeep Service,” whereby you will receive future automatic shipments of updates, new editions and supplements to this edition, as they become available, for a 30-day preview. Updates, new editions and supplements published within 90 days of your purchase will be issued free of charge; all other updates will be subject to an additional charge if kept beyond the preview period, invoiced at the time of delivery. This service will continue until canceled by you at any time. See here.

  • FOLLOW PLI:
  • twitter
  • LinkedIn
  • YouTube
  • RSS

All Contents Copyright © 1996-2018 Practising Law Institute. Continuing Legal Education since 1933.

© 2018 PLI PRACTISING LAW INSTITUTE. All rights reserved. The PLI logo is a service mark of PLI.