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PHARMACEUTICAL COMPLIANCE AND ENFORCEMENT
ANSWER BOOK
2018 Edition
Edited by Howard L. Dorfman
Practising Law Institute
New York City
#239295
This work is designed to provide practical and useful information on the subject matter covered. However, it is sold with the understanding that neither the publisher nor the author is engaged in rendering legal, accounting, or other professional services. If legal advice or other expert assistance is required, the services of a competent professional should be sought.
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HOWARD L DORFMAN (editor, and author of chapter 6, and co-author of chapters 1, 7 and 10) is Founder of H.L. Dorfman Pharmaceutical Consulting, LLC, which provides compliance, regulatory, and risk management consulting services to pharmaceutical and biotech companies, and is an Adjunct Professor and Distinguished Practitioner in Residence at Seton Hall Law School, where he teaches in the Health Law and Healthcare Compliance programs Previously, Mr Dorfman has served in various senior capacities in national and international companies in the health sector. Mr. Dorfman has served as Vice President and General Counsel at Ferring Pharmaceuticals, Inc. in Parsippany, New Jersey, where he was responsible for all legal matters relating to the U.S. affiliate of the Swiss-based global pharmaceutical and biotech company. Previously, he served as a Counsel in the Life Sciences group at Ropes & Gray LLP in New York, where he focused his practice on the pharmaceutical, medical device, and biotech industries.
Mr. Dorfman’s areas of expertise include FDA regulatory law, fraud and abuse, compliance programs, risk management processes, mergers and acquisitions, corporate governance, and product liability. Prior to his time at Ropes & Gray, he was chief legal officer of the pharmaceutical division of Bayer Healthcare LLC, where he was responsible for legal oversight relating to the commercial, regulatory, and compliance activities of the company ’ s pharmaceutical operations. Before joining Bayer, he worked at Bristol-Myers Squibb (BMS), where he first served as Counsel in the Litigation department and subsequently as Counsel to the company ’ s U.S. pharmaceutical operations.
Mr. Dorfman has established OIG compliance processes at major pharmaceutical and biotech companies and start-ups and provides counseling on regulatory, compliance and risk management issues as well as advising companies on compliance with the Foreign Corrupt Practices Act (FCPA) He has lectured and published articles on a range of regulatory, compliance and product liability issues. Mr. Dorfman received his B.A. with honors from Yeshiva University and his J.D. from Brooklyn Law School.
About the Contributors
SARAH M. CUNNINGHAM (chapter 16) is an associate in the Los Angeles office of Gibson, Dunn & Crutcher. She currently practices in the firm’s Litigation Department and is a member of the firm’s White Collar Defense and Investigations and FDA and Health Care practice groups
Previously, Ms. Cunningham served as a law clerk for the Honorable Fernando M. Olguin of the United States District Court for the Central District of California.
Ms Cunningham received her J D , with Pro Bono Distinction, from Stanford Law School in 2013, where she was the Legislative Notes Editor for the Stanford Law and Policy Review. While in law school, Ms. Cunningham was active in the Stanford Community Law Clinic and the Stanford Law Association. Ms. Cunningham earned her B.A., summa cum laude, in History, with a minor in Political Science, from Washington University in St. Louis in 2009 Prior to attending law school, Ms Cunningham was Coro Fellow in Public Affairs.
Ms. Cunningham is currently admitted to practice law in the State of California. She is admitted to practice before the United States District Court for the Northern District of California.
PHILLIP V. DEFEDELE (chapter 7) is an Associate at Buchanan Ingersoll & Rooney PC in Newark, New Jersey and a member of the FDA/Biotechnology Practice Group Mr DeFedele graduated valedictorian, summa cum laude, from Seton Hall University School of Law with a concentration in health law and is an alumnus of The College of New Jersey
Mr. DeFedele focuses on the life sciences industry. He has experience with the laws and industry standards that apply to the research and development, approval, marketing, and sale of pharmaceuticals, medical devices, and biologics Mr DeFedele has negotiated and drafted domestic and international contracts for the clinical development, marketing, and distribution of pharmaceutical products, advised on the laws applicable to clinical trials, and counseled on lawful, non-misleading promotional materials. He also advises on best practices for interactions with healthcare professionals, with a focus on minimizing antikickback risks, and counsels on the setting of compliance priorities based on routine monitoring of government enforcement actions.
ALENA C. GALANTE (chapter 2) is president of Galante Compliance Services, LLC, a firm
specializing in regulatory compliance and quality consulting services for regulated industries. Areas of expertise include inspection readiness planning, auditing, training, ISO certification, Quality Systems development, product recall management, policy and procedure development, business continuity planning, project management, adverse event and product quality complaint management, validation, process re-engineering/excellence and much more
Prior to starting her own company, Ms. Galante worked in the pharmaceutical industry for more than twenty years with companies such as Schering-Plough, Organon Inc., Warner-Lambert, Pfizer, and Johnson & Johnson, and in the aerospace industry for five years. She held progressively responsible roles with a sense of purpose, passion, and integrity Her diverse background includes process and operations expertise in pharmaceuticals, over-the-counter (OTC) consumer healthcare products, medical devices, and the food industry. Fulfilling domestic and global leadership roles in Manufacturing, Quality Assurance, Regulatory, Validation, and Consumer Affairs/Contact Center Operations, her well-rounded background in the business provides a unique skill set that sets her apart from others She has hands-on experience dealing with regulatory issues such as consent decrees, product recalls, FDA inspections, Health Canada privacy inspections, and more. Ms. Galante offers great insight, detailed organization and strategic solutions to compliance issues facing regulated industry leaders today. She is listed in the International Who’s Who of Professionals and Sterling’s Who’s Who Directory of Executives. Ms. Galante is a speaker at many industry conferences as well as an author of related articles She is also an Adjunct Professor at Fairleigh Dickinson University, where she teaches a graduate MBA course on Management of Production, Purchasing and Quality Control in Pharmaceutical Industries.
Ms. Galante has a B.S. in Mechanical Engineering from NJIT; MBA in Pharmaceutical Studies from Fairleigh Dickinson University; Black Belt Certificate in Six Sigma from Kaplan University; and Healthcare Compliance Certificate from Seton Hall University School of Law.
CAITLIN GARRIGAN-NASS (chapter 14) is an associate at Orrick, Herrington & Sutcliffe LLP. Her practice focuses on white collar criminal defense, government investigations, and anti-corruption compliance. She has particular experience with the Foreign Corrupt Practices Act, including internal investigations and criminal proceedings before the U S Department of Justice and the U.S. Securities & Exchange Commission. She also regularly assists in the development and enhancement of corporate compliance and risk mitigation programs. Ms. Garrigan-Nass earned her J.D. with high honors from The George Washington University Law School, where she was a member of The George Washington University Law Review and elected to the Order of the Coif. She received her B.A., summa cum laude, from Wake Forest University. Prior to law school, she was a Fulbright Scholar in France
VICKY G GORMANLY (chapter 13) is an associate in the New York City office of Arnold & Porter Kaye Scholer, LLP, supporting the needs of a variety of pharmaceutical and other healthcare industry clients. She has particular expertise in representing pharmaceutical companies on a broad range of complex regulatory issues, such as the Medicaid Drug Rebate Program, 340B, TRICARE, State Pharmaceutical Assistance Programs, State Supplemental Rebate Programs, Medicare and Medicaid reimbursement, and the AntiKickback Statute. Ms. Gormanly also counsels clients in the negotiation of rebate agreements between pharmaceutical manufacturers and pharmacy benefit managers, managed care companies, and group purchasing agreements.
Ms. Gormanly formerly worked as the Medicaid Program Manager for a major pharmaceutical company, where she managed various aspects of government pricing, including calculation methodology, submissions, and regulatory implementation. She led and served on multifunctional team projects related to risk assessment audits, state supplemental rebate programs, and healthcare reform. Prior to that role, she was the Medicaid Administrator at another pharmaceutical manufacturer, where she managed government pricing and resolved Medicaid Drug Rebate Program disputes
Ms. Gormanly serves in an advisory capacity with The Focus Approach Law Review, where she advises, mentors, and educates students about the Law School Admission Test, the law school admissions application process, and the challenges of being a 1L Ms Gormanly also assists Focus with its diversity initiatives.
JEFFREY L. HANDWERKER (chapter 13) is a partner in the Washington, D.C. office of Arnold & Porter Kaye Scholer LLP Mr Handwerker focuses his practice on pharmaceutical pricing and investigations, government contracts, and commercial litigation involving the pharmaceutical, medical products, and biotechnology industries. In the pharmaceutical pricing area, Mr. Handwerker regularly advises pharmaceutical and medical technology companies on pricing and contracting matters arising under, among other things, the Veterans Health Care Act, the Medicaid Rebate Act, the Deficit Reduction Act of 2005, the Medicare Prescription Drug, Improvement, and Modernization Act, and the Patient Protection and Affordable Care Act He also has advised pharmaceutical companies on some of the most important and cutting-edge issues confronting the industry, including healthcare reform implementation, application of the First Amendment to pharmaceutical communications with healthcare professionals, and novel issues under the federal and state anti-kickback laws. Mr. Handwerker represents clients in litigation matters, internal investigations, and government audits and investigations, including investigations initiated by the U.S. Attorney’s Offices in Philadelphia and Boston, among others. He also has extensive experience litigating cases on behalf of pharmaceutical companies under both state and federal false claims acts.
Mr. Handwerker’s expertise has been widely recognized, including by The Best Lawyers
in America 2015 for FDA Law; Chambers USA: America’s Leading Lawyers for Business 2012–2014 for Healthcare: Pharmaceutical/Medical Products Regulatory (D.C.); and LMG Guide, Life Science Star 2012–2014. He received his J.D., with high honors, from The George Washington University Law School, and his B.A. from Rutgers College.
JAMES F. HLAVENKA (chapter 9) is a Senior Counsel at UCB, Inc. in Atlanta, Georgia, where he serves as a primary counsel to the U.S. Sales, Marketing, and Medical Affairs teams. Mr. Hlavenka provides strategic advice, education, training, and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, privacy, and other laws impacting the commercialization of UCB products Prior to joining UCB, Inc., Mr. Hlavenka was an associate in the FDA & Pharmaceuticals group at Buchanan Ingersoll & Rooney, where he counseled companies on compliant marketing and sales initiatives, fraud and abuse law, and federal and state aggregate spend disclosure reporting.
Mr Hlavenka earned his J D , magna cum laude, with a Certificate in Health Law from Seton Hall University School of Law, where he was President of the Student Bar Association and elected to the Order of the Coif. He received his B.A. from Lafayette College, where he graduated magna cum laude and was elected to Phi Beta Kappa
DANIEL A. KRACOV (chapters 3 and 17) co-chairs Arnold & Porter Kaye Scholer LLP’s life sciences and healthcare regulatory practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval, manufacturing, and marketing of drugs, biologics, and medical devices He has extensive experience in FDA inspections and enforcement matters. His experience in FDA strategic advice and crisis management has been recognized widely, including by Chambers and the Legal Times..
Mr Kracov regularly handles product- and compliance-related investigations, the development of global corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has widely recognized experience in biomedical productrelated public policy matters, including congressional investigations and FDA-related legislative strategies. He is a frequent speaker and author on FDA and compliance topics.
Mr Kracov has a B A , magna cum laude, from the University of Maryland, and a J D from the University of Virginia School of Law.
SCOTT M. LASSMAN (chapter 8) is a partner in the Washington, D.C. law firm of Goodwin Procter LLP (Goodwin), where he provides advice and advocacy on legal, policy, and legislative matters to FDA- regulated companies in the pharmaceutical, biotech, and medical device industries. His areas of expertise focus on pharmaceutical life cycle
management and competition issues, biosimilar approval and policy issues, advertising and promotion, drug and device product approval, and FDA regulatory policy. Mr. Lassman has practiced in the area of FDA regulatory law for over twenty-five years in both private practice and at a national trade association representing the innovative pharmaceutical industry, where he was responsible for FDA regulatory and compliance issues. Mr. Lassman received his J D from the University of Virginia School of Law, an M A in philosophy from the University of Texas at Austin, and a B.A. from Yale University.
TAFARI NIA LUMUMBA (chapter 12) is a litigation associate in the Denver office of Gibson, Dunn & Crutcher LLP His practice focuses on white collar criminal defense, corporate compliance, and complex business litigation. He has represented clients in federal investigations, including a criminal prosecution under the Food, Drug, and Cosmetic Act. Mr. Lumumba is proficient in Spanish and Portuguese, and he has represented clients in connection with internal investigations of alleged violations of antitrust laws and the Foreign Corrupt Practices Act In 2016, Mr Lumumba was named an “Up-and-Coming” lawyer by Law Week Colorado for his work in the white collar defense and corporate compliance space. Mr. Lumumba earned his J.D. from Yale Law School. He received his B.A. from the Colorado College, where he graduated cum laude and was elected to Phi Beta Kappa.
PARI MODY (chapter 17) is an associate in the Washington, D.C. office of Arnold & Porter Kaye Scholer LLP. Ms. Mody counsels a wide range of clients, including manufacturers, healthcare systems, trade associations, and nonprofit research foundations, on issues related to healthcare reform, Medicare coverage and reimbursement, Medicaid, health information technology, federal research funding, and the development, approval, and marketing of FDA-regulated products. She has extensive experience navigating the legislative and regulatory processes, drafting legislative language, preparing comment letters, and developing and implementing legislative and regulatory strategies for individual clients and coalitions Ms Mody frequently works with both congressional and agency-level staff to advocate on behalf of clients.
Ms. Mody earned her J.D. from the University of Maryland Francis King Carey School of Law, magna cum laude and Order of the Coif, and her B.A. from Oberlin College with high honors. She is admitted to practice in the District of Columbia and Maryland.
ANNE ELKINS MURRAY (chapter 14) is a partner in Orrick, Herrington & Sutcliffe LLP’s Washington, D C office, where she is a member of the White Collar and Corporate Investigations practice group. Ms. Murray has extensive experience in anti-corruption matters involving the U S Foreign Corrupt Practice Act, representing multinational corporations and individuals in FCPA matters before the U.S. Department of Justice and
the Securities and Exchange Commission She regularly counsels life sciences companies on anti-corruption matters. In particular, Ms. Murray has developed and enhanced corporate compliance programs, conducted risk assessments, performed pre-acquisition anticorruption diligence, and conducted compliance audits. Ms. Murray received her J.D. from American University, Washington College of Law, where she was an editor of the ABA Administrative Law Review and a member of the school’s Philip C Jessup International Moot Court Competition team that won the national title. Ms. Murray received her B.A. in international studies from Middlebury College.
KATHY O’CONNOR (chapters 5 and 11) is a partner in Orrick, Herrington & Sutcliffe LLP’s New York office. Ms. O’Connor’s practice focuses on complex product liability and commercial claims, consumer fraud class actions, licensing and co-development disputes, and government investigations, primarily for branded pharmaceutical, biotechnology and medical device companies, as well as consumer products companies. She is regularly called upon to advise on litigation and compliance strategy, particularly in complex matters that involve concurrent civil and government actions. She also consults with clients in their effort to manage and mitigate risk. Ms. O’Connor brings a unique perspective to Orrick’s practice, having previously served as an in-house lawyer at Merck.
Prior to joining Orrick, Ms. O’Connor was a litigation partner at Weil Gotshal. She is regularly recognized as a leading practitioner by lawyer ranking entities such as Euromoney Expert Guides’ Women in Business Law and The Legal 500, which singled out her product liability and mass torts defense work.
JOHN D W PARTRIDGE (chapters 12 and 16) is a partner in the Denver office of Gibson, Dunn & Crutcher LLP. His practice focuses on complex litigation, internal investigations, regulatory inquiries, and corporate compliance programs. Mr. Partridge has particular experience with the False Claims Act and the Foreign Corrupt Practices Act, including advising major corporations regarding their compliance programs. Mr. Partridge has represented clients in criminal and civil enforcement actions relating to alleged healthcare fraud and abuse. His substantive experience includes cases involving allegations relating to, among other things, clinical trials, sampling practices, off-label promotion, product defects, and anti-kickback issues. Mr. Partridge received his J.D., with distinction, from Stanford Law School and his B.A., magna cum laude, from Dartmouth College.
STEPHEN C. PAYNE (chapters 12 and 16) is a partner in the Washington, D.C. office of Gibson, Dunn & Crutcher LLP His practice focuses on FDA and healthcare compliance, enforcement, and litigation for pharmaceutical and medical device clients. Mr. Payne has significant FDA and healthcare regulatory and compliance counseling experience in the areas of good manufacturing practice regulations, product recalls, product promotion,
product diversion and counterfeiting, and fraud and abuse He has handled criminal and civil investigations conducted by the FDA Office of Criminal Investigations and the Department of Health and Human Services Office of Inspector General, civil False Claims Act qui tam suits, investigations and litigation conducted by state Attorneys General, and other inquiries and litigation relating to healthcare fraud and abuse and the enforcement of FDA regulations He has also led internal investigations and compliance audits concerning good manufacturing practice regulations, drug sampling and pricing, and promotional practices, including potential off-label promotion and anti-kickback issues.
Mr Payne has received the highest rating of “Leading” by the Practical Law Company in the Cross-border Life Sciences Handbook in the category “Life Sciences: government enforcement and investigations,” and was named a “Life Sciences Star” in the inaugural edition of LMG Life Sciences 2012 in the category “Non-IP Litigation and Enforcement.”
Mr. Payne has served as Senior Trial Counsel for the U.S. Army Judge Advocate General’s Corps at Fort Benning, Georgia and as a Special Assistant U S Attorney in the Middle District of Georgia. While serving in those capacities, he was lead counsel in dozens of investigations and prosecutions, including successful civilian and military jury trials. He received the American Bar Association award for finishing first in his class at the United States Army Judge Advocate General’s (JAG) School, and the City of New York Bar Association award for being named best advocate at the JAG School’s 10th Criminal Law Advocacy Course. Mr. Payne is a graduate of Yale Law School, and he received his undergraduate degree from the School of Industrial and Labor Relations at Cornell University.
LINDA PISSOTT REIG (chapters 9 and 10) is a Shareholder at Buchanan Ingersoll & Rooney PC in Newark, New Jersey and co-chairs the FDA/Biotech Group. Ms. Reig graduated, cum laude, from Georgetown Law School in 1993 and is admitted to the New Jersey and New York State Bars.
Ms Reig focuses her practice on the life sciences industry She has extensive experience with the laws and industry standards that apply to the marketing and sale of pharmaceuticals, medical devices, biologics, dietary supplements, and medical foods. Ms. Reig formerly handled contract disputes and other commercial litigation matters, and defended product liability and consumer fraud lawsuits filed by patients who alleged injury from pharmaceutical and medical devices She counsels companies on how to minimize legal risks in the research, development and commercialization of their FDA-regulated products. She advises on matters such as recruitment of investigators and subjects for clinical trials, as well as compliance with informed consent requirements. She also advises companies on best practices for Safety Committee set-up, adverse event monitoring, package label updates and related matters She also guides companies on pre-approval communications, including payor-directed outreach, as well as set-up and roll-out of so-
called hub services to benefit patients, caregivers and doctors
Ms. Reig conducts compliance training for life sciences companies and prepares and implements policies for lawful interactions with healthcare providers. She has extensive experience in drafting Standard Operating Procedures and Policies for corporate compliance programs, negotiating and drafting contracts, and advising on consulting arrangements with key opinion leaders She has participated on Review Committees for both commercial and pre-commercial companies and advises on how to lawfully communicate about FDA-regulated products. Ms. Reig guides companies on how to minimize legal risk while achieving business objectives by ensuring compliance with laws, such as the Anti-Kickback and False Claims Acts.
Ms. Reig assists companies with their state and federal “Sunshine Act” obligations, and advises on aggregate spend, marketing disclosures, data mining, clinical trial disclosure, adherence to compliance codes, sales representative licensure, and manufacturing/distribution licensure
Ms. Reig was previously recognized by the New Jersey Law Journal on its list of “40 Lawyers Under 40,” which recognizes individuals who are viewed as future leaders of the New Jersey Bar Ms Reig is co-chair of the BioNJ Legal Compliance & Regulatory Advisory Committee, which she was instrumental in forming in 2008.
ROBERT P. REZNICK (chapters 5, 11 and 14) is a partner in the Washington, D.C. office of Orrick, Herrington & Sutcliffe LLP His practice focuses on counseling and representing branded pharmaceutical companies on a wide range of subjects, including antitrust, actions against sellers of counterfeit or illegal drugs, and litigation alleging fraud, consumer protection, False Claims Act claims, food and drug advocacy issues, Foreign Corrupt Practices Act issues, and qui tam litigation. He also advises and represents clients in various industries in connection with U S litigation arising from foreign conduct, and is Managing Editor of The World in US Courts: Orrick’s Quarterly Review of Decisions Applying US Law to Global Business and Cross-Border Activities He received his J D , cum laude, from Harvard University, and a B.S. in Physics from Harvey Mudd College, with distinction and departmental honors.
MICHAEL F RUGGIO (chapter 2) is a partner with Nelson Mullins Riley & Scarborough, LLP in Washington, D.C. His practice focuses on Healthcare Fraud and Abuse and civil False Claims Act investigations, healthcare litigation and healthcare regulatory matters with an emphasis on representing hospitals and other healthcare providers, including medical device and pharmaceutical corporations and their respective officers and directors, in matters relating to federal regulation and investigation He represents healthcare providers in general civil litigation matters as well. He has experience in healthcare antitrust matters,
anti-kickback, Stark and HIPAA He has been involved in numerous pharmaceutical, ehealth technology, and bio-health cases concerning average wholesale pricing issues, reimbursement fraud, medical necessity and other related matters. Mr. Ruggio represents medical device and pharmaceutical companies in civil litigation and FDA compliance. He has served as outside general counsel for the American Association of Health Freedom and Optimal Health, P C He also represents individuals and corporations in white collar and Foreign Corrupt Practices Act matters.
GUY DAVID SINGER (chapter 14) is a partner in Orrick, Herrington & Sutcliffe LLP’s New York office, and a member of the White Collar and Criminal Investigations practice group Mr. Singer also maintains an office in the firm’s Washington, D.C. location. His practice focuses on litigation with an emphasis on white collar and corporate compliance matters. He has provided significant representation with respect to internal investigations involving alleged violations of the Foreign Corrupt Practices Act (FCPA), criminal antitrust investigations, and prosecutions and Department of Justice investigations involving the International Traffic in Arms Regulations. Mr. Singer is a former trial attorney in the Department of Justice’s Criminal Division, Fraud Section, where he earned numerous departmental awards. While at the Department of Justice, he investigated and prosecuted white collar crime and public corruption throughout the United States, from grand jury through trials, including allegations of bribery, bank fraud, money laundering, securities fraud, obstruction of justice, mail/wire fraud, honest services fraud, and violations of the FCPA and Internal Revenue Code Mr Singer earned his J D from New England School of Law, and his B.A. in Psychology from the University of Hartford.
MICHAEL A. SWIT (chapters 4 and 15) of the Law Offices of Michael A. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before returning to private practice in late 2017, Mr. Swit served as the chief regulatory and quality lawyer at Illumina, the leading developer of gene sequencing technology. Prior to joining Illumina in December 2014, he was at Duane Morris LLP as a Special Counsel in the firm’s FDA Law Group in its San Diego office from March 2012. Before Duane Morris, Mr. Swit served for seven years as a Vice President for The Weinberg Group, a premier FDA regulatory consulting firm headquartered in Washington, D.C.
Mr. Swit’s multi-faceted experience includes serving for three and a half years as corporate vice president and general counsel of Par Pharmaceutical, a major publicly traded generic drug manufacturer and serving for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community.
Mr. Swit’s private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White &
McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo (now Denton’s), both in the firm’s Washington, D.C. office and later in San Diego.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA.
A magna cum laude graduate of Bowdoin College, with high honors in history, Mr Swit received his law degree from Emory University School of Law. He is a member of the California Bar.
Preface
I am privileged to introduce the 2018 edition of the PLI Pharmaceutical Compliance and Enforcement Answer Book As first stated in the Preface to the 2014 edition, it has been our intention to present an overview of the enforcement and compliance environment relevant to the pharmaceutical industry in a different and somewhat unique manner as we analyze the overall legal, regulatory, and compliance framework that impacts every facet of the industry’s activities. Continuing in this vein, the 2018 edition takes a holistic approach to define and analyze the rigorous, complex, and frequently overlapping requirements imposed by various federal and state governmental authorities (sometimes working in concert, sometimes working independently) and the role played by third parties in the private sector who collectively contribute to the totality of the current enforcement environment. As we have noted in each edition of the Answer Book, the one constant in the overall process has been continuing change.
To identify and address the requirements facing the industry, one must consider the three major forces that impact the practices and policies of the pharmaceutical manufacturer, from the laboratory through the completion of the life cycle of a prescription pharmaceutical. First and foremost, the provisions of the Food, Drug, and Cosmetic Act (FDCA) as enforced by the Food and Drug Administration (FDA)1 provide the regulatory framework upon which all additional sources of enforcement, both public and private, are premised The statutes and regulations have evolved over time, most frequently in response to unanticipated and negative developments impacting the public health (for example, the passage of the Kefauver Amendments in 1962 as a response to the thalidomide tragedy) These events provided the impetus to Congressional action that expanded FDA’s authority over the industry and resulted in the imposition of new requirements on manufacturers, beginning from the earliest stages of the drug development process through post-approval commercialization. One of the most far-reaching regulatory developments came in 2007 with the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) which provided FDA with power to direct manufacturer conduct in areas that were previously beyond FDA’s authority, including FDA-promulgated label changes, risk management procedures, and mandating specific distribution channels for marketed drugs. In addition, FDA has relied upon the FDCA to implement and enforce additional changes through such procedures as issuance of guidelines, on-site inspections, and both civil and criminal enforcement measures. Regulatory action implemented through issuance of draft guidance documents has become a more frequently utilized (and now criticized) procedure.
As noted in this edition, a more recent legislative initiative in the form of the 21st
Century Cures Act has introduced the promise of even greater changes to the drug regulatory process as Congress and FDA continue to modernize the requirements and pathways in the development and approval of pharmaceuticals. It remains to be seen what changes the implementing legislation and future FDA actions will bring to the pharmaceutical industry.
Of course, not all FDA-proposed rules are finalized A significant development in the regulatory area was the release of a Proposed Rule from FDA Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 2 The Proposed Rule would permit generic companies to incorporate newly discovered information into their product labeling prior to specific FDA authorization. The rule could have a profound impact on labeling both for generics and innovator companies, as well as impact product liability exposure for a new class of manufacturers. On December 4, 2015, the FDA postponed (for the second time) its schedule for finalizing the generic drug labeling changes contained in the 2013 draft guidance. The new date proposed in January 2016 extended the deadline yet again without any final action taken.
Another significant change may be developing as the DOJ has announced its intention to require the government agencies subject to its enforcement authority to utilize the stricter notice and comment requirements of the Administrative Procedure Act instead of continuing the guidance process. Since a major aspect of FDA oversight has been accomplished through the release of various guidance documents (some in draft form that are never finalized), it is likely that the industry’s ability to rely on these guidances to revise their internal processes and procedures may in fact be adversely impacted.
Regulatory oversight by FDA is only one of the pillars of enforcement. The second arises from the compliance obligations imposed by federal and state agencies, most notably the U.S. Department of Justice (DOJ) in conjunction with the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) as well as the various state attorneys general. Although much of the statutory framework had been in place for a longer period of time,3 the issuance of compliance guidelines for pharmaceutical manufacturers by the OIG in 2003 is often seen as the beginning of a new period of rigorous enforcement of pharmaceutical commercialization activities that are considered violations of federal and state health reimbursement laws. Since then, the DOJ and the OIG have investigated, charged, and settled with pharmaceutical manufacturers for violations of the False Claims Act, the Anti-Kickback Statute, as well as price reporting statutes, resulting in significant monetary fines and reimbursements to government entities (several exceeding $2 billion and $3 billion dollars) Often, multiple states have instituted their own lawsuits in conjunction with federal actions, basing liability on various state laws including state False Claims Acts and consumer protection laws. In addition to the financial impact, the manufacturers have entered into stringent Corporate Integrity Agreements (CIAs) and Deferred Prosecution Agreements (DPAs) that impose processes and procedures affecting
every aspect of corporate conduct, including oversight of the review and approval of advertising and promotion, responding to requests from healthcare professionals for offlabel, albeit scientifically accurate and balanced, medical information, and the conduct and supervision of the medical communication function (internal and field-based). Both governmental entities have imposed quasi-regulatory requirements on manufacturers4 beyond those imposed by the FDA.
The often overlapping focus of enforcement initiatives by FDA and the DOJ/OIG isreflected in the Center for Drug Evaluation and Research (CDER) 2016 priorities issued by Janet Woodcock, M.D. that indicated CDER’sintention to “re-evaluate our regulation of drug advertising and promotion in light of current Jurisprudence around the 1st Amendment” following a series of reversals of FDA enforcement initiatives against manufacturers for off-label promotion. Recent cases, Amarin Pharma Inc. v. FDA, 5 as well as related issues and developments in this area and Pacira Pharmaceuticals v. FDA, 6 are discussed in considerable detail in the revised chapter 7 to this volume.
The extensively revised chapter 7, as well as the significantly updated chapter 6, focus on the intense legal, regulatory, and compliance activity surrounding the issue of the impact of the First Amendment on the promotional activities of pharmaceutical manufacturers as well as on the general question of appropriate dissemination of accurate and non-misleading medical and scientific information where formal FDA labeling approval has not been granted. The FDA convened a two-day conference in 2016, following a series of adverse appellate decisions in the Second Circuit, to focus on these issues and to obtain input from a range of stakeholders FDA issued two draft guidance documents in January 2017 one regarding communication with payors and formulary committees and a second addressing communications by medical product manufacturers that are consistent with FDA labeling. In addition, a memorandum containing additional background regarding the agency ’ s views on off-label enforcement and the First Amendment was also issued with a comment period extended to April 19, 2017 We anticipate additional activity in this area by FDA as well as by the OIG and the DOJ in the future.
Nevertheless, the industry has seen a reduction in the number and size of settlements reached between the OIG/DOJ and pharmaceutical companies, as noted in this year ’ s update. The focus appears to have shifted from FCA and FDCA violations arising from offlabel promotion of FDA-approved and marketed drugs to other areas of the FDA regulatory process such as actions taken by companies during the pre-approval period.
The third pillar of pharmaceutical enforcement is one frequently overlooked, that being product liability Yet litigation not only presents financial burdens on the pharmaceutical manufacturer in the form of costs in discovery, attorneys ’ fees, and settlements and/or judgments, but presents challenges to the regulatory process in determining whether risk identification and management processes are sufficient to provide a scientifically rigorous
defense to a lawsuit alleging failure to warn or an inadequate warning The debate over preemption for the pharmaceutical manufacturer, absent express preemption in the FDCA, has been engaged again with the Supreme Court having last addressed the issue in the Wyeth v. Levine7 case. Given that the FDA authority to require additional and upgraded warnings under the risk management provisions of the FDAAA has yet to be addressed in the context of preemption, the issue is yet to be determined with finality.
Another litigation-related issue has arisen in the context of generic pharmaceutical manufacturers. In Pliva, Inc v Mensing, 8 a case involving liability on the part of a generic manufacturer, the Supreme Court found conflict preemption where federal law barred a generic company from unilaterally changing its label and state tort law, upheld liability for the failure to make such changes. It will be interesting to follow the course of the FDA Proposed Rule on extending the Changes Being Effected (CBE) provisions of the FDCA to generics and the potential impact on liability exposure of generics. The issue of the innovator versus generic liability remains contentious, not only as seen in the FDA draft guidance awaiting further action, but also in terms of the claims of generic manufacturers that innovators are using inappropriate means to prevent their ability to access risk management programs (REMS) approved by the FDA for innovator products. These continuing disputes can yet have implications for liability exposure for both innovator and generic manufacturers.
One important development has been observed in the continuing question of liability of innovator pharmaceutical companies for damages incurred following exposure to those companies’ generic counterparts While the majority of cases following the Conte v Wyeth9 decision have rejected innovator liability where only a generic form of the drug was administered, a series of cases continue to emerge embracing some form of such liability, the most recent issued by the Massachusetts Supreme Judicial Court imposing liability on an innovator manufacturer for injuries caused by a generic drug in Rafferty v. Merck & Co. 10
In addition, Congress has continued to show interest in extending the provisions of CBE to generic manufacturers which would reduce judicial pressure to impose liability on innovators (where courts have been reluctant to deny an injured party recovery for injuries) but place a significant potential burden on generic manufacturers where none had existed previously.
The enforcement environment impacting the pharmaceutical industry remains in a continuing state of change. We hope this 2018 edition will serve to identify these changes and provide useful guidance on the issue of pharmaceutical industry enforcement to all those involved in this field, including manufacturers, academics, and law firms practicing in the area
HOWARD L. DORFMAN
1 There are other federal agencies that represent additional sources of regulatory oversight and enforcement, depending to a large extent on the nature of the drug and the therapeutic profile, such as the Drug Enforcement Agency (DEA). This volume, while referencing these agencies as the context dictates, will generally focus on the enforcement authority and activities of the FDA
2 78 Fed. Reg. 67,985 (Nov. 13, 2013).
3. The federal False Claims Act, relied upon in conjunction with elements of the FDCA to prosecute pharmaceutical companies for off-label promotion, was passed during the Civil War to prosecute manufacturers of defective armaments supplied to Union forces
4 One state required the settling pharmaceutical manufacturer to impose stricter procedures in the form of having filed or intending to file a supplemental New Drug Application (sNDA) before disseminating off-label medical literature discussing that unapproved indication. The FDA Guidance on Dissemination of Off-Label Reprints does not contain that requirement.
5. Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015).
6 Pacira Pharm., Inc. v. FDA, 1:15-7055-RA (S.D.N.Y. 2015).
Chapter 1 Overview of the FDA Regulatory Process Pre- and Post-Approval and the 21st Century Cures Act
Chapter 2 FDA Enforcement Facility Inspections
Chapter 3 483s and Warning Letters
Chapter 4 FDA Regulations and Enforcement Actions Relative to Oversight of Advertising and Promotion
Chapter 5 Federal and State Regulation and Enforcement of Pharmaceutical Manufacturers’ Advertising and Promotional Activity
Chapter 6 Regulatory and Compliance Implications of Disseminating Medical Information and the Distinction with Off-Label Promotion
Chapter 7 Current Status of the Impact of the First Amendment on Off-Label Promotion
Chapter 8 Food and Drug Administration Amendments Act of 2007 and the Growth of FDA Enforcement Authority
Chapter 9 Risk Evaluation and Mitigation Strategies (REMS) and Related PostMarket Safety Oversight
Chapter 10 Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers
Chapter 11 Specific FDA Enforcement Tools
Chapter 12 Criminal Prosecution As a U.S. Food and Drug Administration Enforcement Tool
Chapter 13 Pharmaceutical Price Reporting: The “ABCs” and “123s” of Compliance
Chapter 14 The Foreign Corrupt Practices Act and Its Impact on the Pharmaceutical Industry
Chapter 15 Collateral Consequences of Violating the Federal Food, Drug, and Cosmetic Act
Chapter 16 Prescription Drug Sampling Regulation and Enforcement
Chapter 17 The 21st Century Cures Act: Overview and Impact on Product Development and the U.S. Food & Drug Administration
Table of Contents
About the Editor
About the Contributors
Preface
Table of Chapters
Table of Contents
Chapter 1 Overview of the FDA Regulatory Process Pre- and Post-Approval and the 21st Century Cures Act
Howard L Dorfman
Introductory Definitions
Q 1.1 What is FDA?
Q 1 2 What is the Federal Food, Drug, and Cosmetic Act?
Q 1.3 What is a drug?
Q 1.4 What is a new drug?
Q 1.5 What is a biologic?
Q 1.6 What is an IND?
Q 1 7 What is a clinical trial?
Q 1.8 What is an IRB?
Q 1.9 What is an NDA?
Q 1.10 What is a BLA?
Q 1 11 What is an ANDA?
Q 1.12 What is a 351(k) application?
Q 1.13 What is a 505(b)(2) application?
Q 1.14 What is a generic drug?
Q 1 15 What is a biosimilar product?
Q 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?
FDA’s Enforcement Authority
Q 1.17 What is the source of FDA’s enforcement authority with respect to drugs and biologics?
Q 1 17 1 What is the source of FDA authority with respect to drugs pre-approval?
Q 1.17.2 What is the source of FDA authority with respect to drugs post-approval?
Q 1.18 What is the rationale behind FDA enforcement?
Pre-Approval Regulation
Q 1.19 What approval does FDA require for the permissible sale of innovator drugs?
Q 1 20 How does a manufacturer obtain FDA approval to sell an innovator drug?
Q 1.20.1 What is the research process involved in seeking approval for an innovator drug?
Q 1.20.2 What are the phases of clinical testing that lead to approval?
Q 1.20.3 When is IRB approval necessary?
Q 1 20 4 Who conducts the clinical trials?
Q 1.20.5 What are a sponsor ’ s and investigator’s responsibilities in conducting a clinical trial?
Q 1.20.6 What registration requirements apply to clinical trials?
Q 1.20.7 What are the standards of approval for an NDA?
Q 1 20 8 What is the “substantial evidence” standard?
Q 1.20.9 How does the Cures Act seek to expand the type of data that may be submitted in support of pharmaceutical development?
Q 1.20.10 What are fast track, breakthrough therapy, accelerated approval, and priority review?
Q 1.20.11 Under what circumstances is a 505(b)(2) application appropriate?
Q 1 21 What approval does FDA require for the sale of generic drugs?
Q 1.22 How does a manufacturer obtain FDA approval to sell a generic drug?
Q 1.23 How does a manufacturer obtain FDA approval to sell a biologic?
Q 1 23 1 How does a manufacturer obtain FDA approval to sell a biosimilar product?
Q 1.24 How does FDA communicate its approval decisions?
Post-Approval Regulation
Q 1.25 What post-approval acts can FDA require a manufacturer to undertake?
Q 1.26 When does FDA reconsider or withdraw approval of a drug?
Q 1.27 How does FDA regulate manufacturing practices?
Q 1 28 What drug-related communications does FDA regulate?
Q 1.28.1 What is a drug’s labeling?
Q 1 28 2 What standards and prohibitions apply to labeling?
Q 1.28.3 What is a drug’s advertising?
Q 1.28.4 What standards and prohibitions apply to advertisements?
Q 1 28 5 How does FDA regulate drug promotion?
Q 1.28.6 What is off-label promotion?
Q 1.29 What are FDA’s formal enforcement tools?
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I feel the rebuke—
George, I must leave thee—I hear footsteps. Farewell—
So soon—so very soon! Say to her, I beseech you—say to her as you have said to me, that she may confess if she will; that we have been together, and that we have both agreed in the opinion that she had better confess and throw herself on the mercy of her judges, till the fury of the storm hath passed over.—It will soon have passed over, I am sure now—
No George, no; but I will say this. I will say to her—
Go on—go on, I beseech you—
—I will say to her—Elizabeth, my dear Sister; go down upon thy knees and pray to the Lord to be nigh to thee, and give thee strength, and to lead thee in the path which is best for his glory; and after that, if thee should feel free to preserve thy life by such means —being on the guard against the love of life, and the fear of death— the Tempter of souls, and the weapons of the flesh—it will be thy duty so to preserve it.
Burroughs groaned aloud—but he could prevail no further Enough, said he, at last: write as much on this paper, and let me carry it with me.
Carry it with thee—what do thee mean?
I hardly know what I mean; I would see her and urge her to live, but when I consider what must follow, though I have permission to see her, my heart fails me.
Thee is to meet her with me, I suppose?
No, I believe not—
How—alone?—
No no—not alone, said the jailor, whom they supposed to be outside of the door, till he spoke.
More of the tender mercies of the law! They would entrap thee George—
And you too Rachel, if it lay in their power—
Give me that book—it is the Bible that I gave thee, is it not?
It is—
It belonged to my mother. I will write what I have to say in the blank leaf.
She did so; and giving it into the hands of the Jailor she said to him —I would have her abide on earth—my dear, dear sister!—I would pray to her to live and be happy, if she can; for she—O she will have much to make life dear to her, even though she be left alone by the way-side for a little time—what disturbs thee George?——
I am afraid of this man. He will betray us—
No—no—we have nothing to fear—
Nothing to fear, when he must have been at our elbow and overheard everything we have whispered to each other.
Look at him George, and thee will be satisfied.
Burroughs looked up, and saw by the vacant gravity of his hard visage, that the man had not understood a syllable to their prejudice.
But Elizabeth—I would have her continue on earth, I say—I would— if so it may please our Father above; but I am in great fear, and I would have thee tell her so, after she has read what I have written there in that book. She will have sympathy, whatever may occur to us—true sympathy, unmixed with fear; but as for me, I have no such hope—and why should I wrestle with my duty—I—who have no desire to see the light of another day?
None Rachel?
None—but for the sake of Mary Elizabeth Dyer—and so—and so George, we are to part now—and there—therefore—the sooner we part, the better. Her voice died away in a low deeply-drawn heavy breathing.
Even so dear—even so, my beloved sister—
George—
Nay, nay—why leave me at all?—why not abide here? Why may we not die together?
George, I say—
Well—what-say?
Suffer me to kiss thee—my brother—before we part.... He made no reply, but he gasped for breath and shook all over, and stretched out his arms with a giddy convulsive motion toward her.
—Before we part forever George—dear George, putting her hand affectionately upon his shoulder and looking him steadily in the face. We are now very near to the threshold of death, and I do believe—I do—though I would not have said as much an hour ago, for the wealth of all this world ... nay, not even to save my life ... no ... nor my sister’s life ... nor thy life ... that I shall die the happier and the better for having kissed thee ... my brother.
Still he spoke not ... he had no tongue for speech. The dreadful truth broke upon him all at once now, a truth which penetrated his heart like an arrow ... and he strove to throw his arms about her; to draw her up to his bosom—but the chains that he wore prevented him, and so he leaned his head upon her shoulder ... and kissed her cheek, and then lifted himself up, and held her with one arm to his heart, and kissed her forehead and her eyes and her mouth, in a holy transport of affection.
Dear George ... I am happy now ... very, very happy now, said the poor girl, shutting her eyes and letting two or three large tears fall upon his locked hands, which were held by her as if as if while her mouth was pressed to them with a dreadful earnestness, her power to let them drop was no more. And then she appeared to recollect herself, and her strength appeared to come back to her, and she rose up and set her lips to his forehead with a smile, that was remembered by the rough jailor to his dying day, so piteous and so death-like was it, and said to Burroughs, in her mild quiet way— her mouth trembling and her large tears dropping at every word— very, very happy now, and all ready for death. I would say more ...
much more if I might, for I have not said the half I had to say Thee will see her ... I shall not see her again....
How—
Not if thee should prevail with her to stay, George. It would be of no use—it would only grieve her, and it might unsettle us both—
What can I say to you?
Nothing—Thee will see her; and thee will take her to thy heart as thee did me, and she will be happy—very happy—even as I am now.
Father—Father! O, why was I not prepared for this! Do thou stay me —do thou support me—it is more than I can bear! cried Burroughs, turning away from the admirable creature who stood before him trying to bear up without his aid, though she shook from head to foot with uncontrollable emotion.
Thee’s very near and very dear to Mary Elizabeth Dyer; and she— she will be happy—she cannot be otherwise, alive or dead—for all that know her, pity her and love her——
And so do all that know you—
No, no, George, love and pity are not for such as I—such pity I mean, or such love as we need here—need I say, whatever we may pretend, whatever the multitude may suppose, and however ill we may be fitted for inspiring it—I—I—
Her voice faltered, she grew very pale, and caught by the frame of the door—
—There may be love, George, there may be pity, there may be some hope on earth for a beautiful witch ... with golden hair ... with large blue eyes ... and a sweet mouth ... but for a ... for a ... for a freckled witch ... with red hair and a hump on her back—what hope is there, what hope on this side of the grave?
She tried to smile when she said this ... but she could not, and the preacher saw and the jailor saw that her heart was broken. Before the former could reply, and before the latter could stay her, she was gone.
The rest of the story is soon told. The preacher saw Elizabeth and tried to prevail with her, but he could not. She had all the courage of her sister, and would not live by untruth. And yet she escaped, for she was very ill, and before she recovered, the fearful infatuation was over, the people had waked up, the judges and the preachers of the Lord; and the chief-judge, Sewall had publicly read a recantation for the part he had played in the terrible drama. But she saw her brave sister no more; she saw Burroughs no more—he was put to death on the afternoon of the morrow, behaving with high and steady courage to the last—praying for all and forgiving all, and predicting in a voice like that of one crying in the wilderness, a speedy overthrow to the belief in witchcraft—a prophecy that came to be fulfilled before the season had gone by, and his last words were—“Father forgive them, for they know not what they do!”
Being dead, a messenger of the court was ordered away to apprise Rachel Dyer that on the morrow at the same hour, and at the same place, her life would be required of her.
She was reading the Bible when he appeared, and when he delivered the message, the book fell out of her lap and she sat as if stupified for a minute or more; but she did not speak, and so he withdrew, saying to her as he went away, that he should be with her early in the morning.
So on the morrow, when the people had gathered together before the jail, and prepared for the coming forth of Rachel Dyer, the HighSheriff was called upon to wake her, that she might be ready for death; she being asleep the man said. So the High-Sheriff went up and spoke to her as she lay upon the bed; with a smile about her mouth and her arm over a large book ... but she made no reply. The bed was drawn forth to the light—the book removed (it was the Bible) and she was lifted up and carried out into the cool morning air She was dead.
HISTORICAL FACTS.
That the reader may not be led to suppose the book he has just gone through with, a sheer fabrication, the author has thought it adviseable to give a few of the many facts upon which the tale is founded, in the very language of history.
The true name of Mr. Paris was Samuel, instead of Matthew, and he spelt it with two r’s; that of his child was Elizabeth and that of her cousin, Abigail Williams. With these corrections to prepare the reader for what is to follow, we may now go to the historical records alluded to.
And first—Of the manner in which the accused were treated on their examination, and of the methods employed to make them confess.
John Proctor, who was executed for witchcraft, gives the following account of the procedure had with his family, in a letter to Mr. Cotton Mather, Mr. Moody, Mr. Willard, and others.
“Reverend Gentlemen, The innocency of our case, with the enmity of our accusers and our judges and jury, whom nothing but our innocent blood will serve, having condemned us already before our trials, being so much incensed and enraged against us by the devil, makes us bold to beg and implore your favourable assistance of this our humble petition to his excellency, that if it be possible our innocent blood may be spared, which undoubtedly otherwise will be shed, if the Lord doth not mercifully step in; the magistrates, ministers, juries, and all the people in general, being so much enraged and incensed against us by the delusion of the devil, which we can term no other, by reason we know in our own consciences we are all innocent persons Here are five persons who have lately confessed themselves to be witches, and do accuse some of us of being along with them at a sacrament, since we were committed into close prison, which we know to be lies. Two of the five are (Carrier’s sons) young men, who would not confess any thing till they tied them neck and heels, till the blood was ready to come out of their noses; and it is credibly believed and reported this was the occasion of making them confess what they
never did, by reason they said one had been a witch a month, and another five weeks, and that their mother had made them so, who has been confined here this nine weeks My son William Proctor, when he was examined, because he would not confess that he was guilty, when he was innocent, they tied him neck and heels till the blood gushed out at his nose, and would have kept him so twenty-four hours, if one, more merciful than the rest, had not taken pity on him, and caused him to be unbound These actions are very like the popish cruelties They have already undone us in our estates, and that will not serve their turns without our innocent blood. If it cannot be granted that we have our trials at Boston, we humbly beg that you would endeavor to have these magistrates changed, and others in their rooms; begging also and beseeching you would be pleased to be here, if not all, some of you, at our trials, hoping thereby you may be the means of saving the shedding of innocent blood. Desiring your prayers to the Lord in our behalf, we rest your poor afflicted servants, J P , &c
Jonathan Cary, whose wife was under the charge, but escaped, has left a very affecting narrative of her trial, and of the behavior of the judges.
“Being brought before the justices, her chief accusers were two girls My wife declared to the justices, that she never had any knowledge of them before that day She was forced to stand with her arms stretched out I requested that I might hold one of her hands, but it was denied me; then she desired me to wipe the tears from her eyes, and the sweat from her face, which I did; then she desired that she might lean herself on me, saying she should faint.
Justice Hathorn replied, she had strength enough to torment those persons, and she should have strength enough to stand I speaking something against their cruel proceedings, they commanded me to be silent, or else I should be turned out of the room The Indian before mentioned was also brought in, to be one of her accusers: being come in, he now (when before the justices) fell down and tumbled about like a hog, but said nothing The justices asked the girls who afflicted the Indian; they answered she, (meaning my wife) and that she now lay upon him; the justices ordered her to touch him, in order to his cure, but her head must be turned another way, lest, instead of curing, she should make him worse, by her looking on him, her hand being guided to take hold of his; but the Indian took hold of her hand, and pulled her down on the floor, in a barbarous manner; then his hand was taken
off, and her hand put on his, and the cure was quickly wrought. I, being extremely troubled at their inhuman dealings, uttered a hasty speech, That God would take vengeance on them, and desired that God would deliver us out of the hands of unmerciful men Then her mittimus was writ I did with difficulty and chagrin obtain the liberty of a room, but no beds in it; if there had been, could have taken but little rest that night She was committed to Boston prison; but I obtained a habeas corpus to remove her to Cambridge prison, which is in our county of Middlesex Having been there one night, next morning the jailer put irons on her legs (having received such a command;) the weight of them was about eight pounds; these irons and her other afflictions soon brought her into convulsion fits, so that I thought she would have died that night. I sent to entreat that the irons might be taken off; but all entreaties were in vain, if it would have saved her life, so that in this condition she must continue. The trials at Salem coming on, I went thither, to see how things were managed; and finding that the spectre evidence was there received, together with idle, if not malicious stories, against people’s lives, I did easily perceive which way the rest would go; for the same evidence that served for one, would serve for all the rest I acquainted her with her danger; and that if she were carried to Salem to be tried, I feared she would never return I did my utmost that she might have her trial in our own county, I with several others petitioning the judge for it, and were put in hopes for it; but I soon saw so much, that I understood thereby it was not intended, which put me upon consulting the means of her escape; which through the goodness of God was effected, and she got to Rhode-Island, but soon found herself not safe when there, by reason of the pursuit after her; from thence she went to New-York, along with some others that had escaped their cruel hands.
Of the trial of “good-wife Proctor,” the following interpretation was had.
“About this time, besides the experiment of the afflicted falling at the sight, &c they put the accused upon saying the Lord’s prayer, which one among them performed, except in that petition, deliver us from evil, she expressed it thus, deliver us from all evil: this was looked upon as if she prayed against what she was now justly under, and being put upon it again, and repeating those words, hallowed be thy name, she expressed it, hollowed be thy name: this was counted a depraving the words, as signifying to make void, and so a curse rather than a prayer: upon the whole it was concluded that she also could
not say it, &c. Proceeding in this work of examination and commitment, many were sent to prison.
“In August, 1697, the superior court sat at Hartford, in the colony of Connecticut, where one mistress Benom was tried for witchcraft. She had been accused by some children that pretended to the spectral sight: they searched her several times for teats; they tried the experiment of casting her into the water, and after this she was excommunicated by the minister of Wallinsford. Upon her trial nothing material appeared against her, save spectre evidence. She was acquitted, as also her daughter, a girl of twelve or thirteen years old, who had been likewise accused; but upon renewed complaints against them, they both flew into New-York government.
Second—Of the Confessions.—The following is a letter written by six of the confessing witches, by which it may be understood in some degree how they came to accuse themselves.
“We, whose names are under written, inhabitants of Andover, when as that horrible and tremendous judgment beginning at Salem Village, in the year 1692, (by some called witchcraft) first breaking forth at Mr. Parris’s house, several young persons being seemingly afflicted, did accuse several persons for afflicting them, and many there believing it so to be; we being informed that if a person were sick, the afflicted person could tell what or who was the cause of that sickness: Joseph Ballard of Andover (his wife being sick at the same time) he either from himself, or by the advice of others, fetched two of the persons, called the afflicted persons, from Salem Village to Andover: which was the beginning of that dreadful calamity that befel us in Andover And the authority in Andover, believing the said accusations to be true, sent for the said persons to come together to the meeting-house in Andover (the afflicted persons being there.) After Mr. Barnard had been at prayer, we were blindfolded, and our hands were laid upon the afflicted persons, they being in their fits, and falling into their fits at our coming into their presence [as they said] and some led us and laid our hands upon them, and then they said they were well, and that we were guilty of afflicting of them whereupon we were all seized as prisoners, by a warrant from a justice of the peace, and forthwith carried to Salem. And by reason of that sudden surprisal, we knowing ourselves altogether innocent of that crime, we were all exceedingly astonished and amazed, and affrighted even out of our reason; and our nearest and dearest relations, seeing us in that dreadful condition, and knowing our great danger, apprehending that there was no other way to save our lives, as the case was then circumstanced, but by our
confessing ourselves to be such and such persons, as the afflicted represented us to be, they out of tender love and pity persuaded us to confess what we did confess And indeed that confession, that it is said we made, was no other than what was suggested to us by some gentlemen; they telling us, that we were witches, and they knew it, and we knew it, and they knew that we knew it, which made us think that it was so; and our understanding, our reason and our faculties almost gone, we were not capable of judging our condition; as also the hard measures they used with us rendered us uncapable of making our defence; but said anything which they desired: and most of what we said was but in effect a consenting to what they said. Sometime after, when we were better composed, they telling of us what we had confessed, we did profess that we were innocent, and ignorant of such things. And we hearing that Samuel Wardwell had renounced his confession, and quickly after was condemned and executed, some of us were told that we were going after Wardwell.
M O ,
A B , M T , S W , D D , H T ”
“It may here be further added, concerning those that did confess, that besides that powerful argument, of life (and freedom from hardships, not only promised, but also performed to all that owned their guilt) there are numerous instances, too many to be here inserted, of the tedious examinations before private persons, many hours together; they all that time urging them to confess (and taking turns to persuade them) till the accused were wearied out by being forced to stand so long or for want of sleep, &c and so brought to give an assent to what they said; they then asking them, Were you at such a witch meeting? or, Have you signed the devil’s book? &c. Upon their replying, Yes, the whole was drawn into form, as their confession.
“But that which did mightily further such confessions was, their nearest relations urging them to it These, seeing no other way of escape for them, thought it the best advice that could be given; hence it was that the husbands of some, by counsel often urging, and utmost earnestness, and children upon their knees intreating, have at length prevailed with them to say they were guilty
Third—Of the character of Burroughs;—about which there has been from that day to this, a great difference of opinion. His readiness to forgive.
“Margaret Jacobs being one that had confessed her own guilt, and testified against her grandfather Jacobs, Mr. Burroughs and John Willard, she the day before execution came to Mr Burroughs, acknowledging that she had belied them, and begged Mr Burroughs’s forgiveness; who not only forgave her, but also prayed with and for her
Apparitions at the trial.—
“Accordingly several of the bewitched had given in their testimony, that they had been troubled with the apparitions of two women, who said they were G. B.’s two wives; and that he had been the death of them; and that the magistrates must be told of it, before whom, if B. upon his trial denied it, they did not know but that they should appear again in the court. Now G. B. had been infamous, for the barbarous usage of his two successive wives, all the country over. Moreover, it was testified the spectre of G. B. threatening the sufferers, told them he had killed [besides others] Mrs Lawson and her daughter Ann And it was noted, that these were the virtuous wife and daughter of one, at whom this G B might have a prejudice, for being serviceable at Salem Village, from whence himself had in ill terms removed some years before; and that when they died, which was long since, there were some odd circumstances about them, which made some of the attendants there suspect something of witchcraft, though none imagined from what quarter it should come.
“Well, G. B. being now upon his trial, one of the bewitched persons was cast into horror at the ghosts of B.’s two deceased wives, then appearing before him, and crying for vengeance against him Hereupon several of the bewitched persons were successively called in, who all, not knowing what the former had seen and said, concurred in their horror of the apparition, which they affirmed that he had before But he, though much appalled, utterly denied that he discerned any thing of it, nor was it any part of his conviction
His bodily strength.—
“A famous divine recites this among the convictions of a witch; the testimony of the party bewitched, whether pining or dying; together with the joint oaths of sufficient persons, that have seen certain prodigious pranks, or feats, wrought by the party accused. Now God had been pleased so to leave G. B. that he had ensnared himself, by several instances, which he had formerly given, of a preternatural strength; and which were now produced against him He was a very puny man yet he had often done things beyond the strength of a giant
A gun of about seven feet barrel, and so heavy that strong men could not steadily hold it out, with both hands; there were several testimonies given in by persons of credit and honour, that he made nothing of taking up such a gun behind the lock with but one hand, and holding it out, like a pistol, at arm’s end G B in his vindication was so foolish as to say, that an Indian was there, and held it out, at the same time; whereas, none of the spectators ever saw any such Indian; but they supposed the black man (as the witches call the devil, and they generally say he resembles an Indian) might give him that assistance. There was evidence likewise brought in, that he made nothing of taking up whole barrels filled with molasses, or cider, in very disadvantageous postures, and carrying them off, through the most difficult places, out of a canoe to the shore.
“Yea, there were two testimonies, that G B with only putting the forefinger of his right hand into the muzzle of a heavy gun, a fowling piece of about six or seven feet barrel, lifted up the gun, and held it out at arm’s end; a gun which the deponents, though strong men, could not with both hands lift up, and hold out at the butt-end, as is usual Indeed one of these witnesses was over-persuaded by some persons to be out of the way upon G. B.’s trial; but he came afterwards, with sorrow for his withdrawing, and gave in his testimony.
His death.—
“Mr. Burroughs was carried in a cart with the others, through the streets of Salem to execution. When he was upon the ladder, he made a speech for the clearing of his innocency, with such solemn and serious expressions, as were to the admiration of all present: his prayer [which he concluded by repeating the Lord’s prayer] was so well worded, and uttered with such composedness, and such [at least seeming] fervency of spirit, as was very affecting, and drew tears from many, so that it seemed to some that the spectators would hinder the execution The accusers said the Black Man stood and dictated to him. As soon as he was turned off, Mr. Cotton Mather, being mounted upon a horse, addressed himself to the people, partly to declare that he [Burroughs] was no ordained minister, and partly to possess the people of his guilt, saying that the devil has often been transformed into an angel of light; and this somewhat appeased the people, and the executions went on.
Fourth—A trial at length. Indictment of Elizabeth How.
ESSEX ss
Anno Regni Regis & Reginæ Willielmi & Mariæ, nunc
Angliæ, &c, quarto
The jurors for our sovereign lord and lady the king and queen present, that Elizabeth How, wife of James How, of Ipswich, in the county of Essex, the thirty-first day of May, in the fourth year of the reign of our sovereign lord and lady William and Mary, by the grace of God, of England, Scotland, France and Ireland, king and queen, defenders of the faith, &c and divers other days and times, as well before as after, certain destestable arts, called witchcrafts and sorceries, wickedly and feloniously hath used, practised and exercised, at and within the township of Salem, in, upon and against one Mary Wolcott, of Salem Village, in the county aforesaid, single woman; by which said wicked arts the said Mary Wolcott, the said thirty-first day of May, in the fourth year above-said, and divers other days and times, as well before as after, was and is tortured, afflicted, pined, consumed, wasted and tormented; and also for sundry other acts of witchcrafts, by said Elizabeth How committed and done before and since that time, against the peace of our sovereign lord and lady, the king and queen, and against the form of the statute in that case made and provided.
Witnesses—Mary Wolcott, Ann Putman, Abigail Williams, Samuel Pearly, and his wife Ruth, Joseph Andrews, and wife Sarah, John Sherrin, Joseph Safford, Francis Lane, Lydia Foster, Isaac Cummins, jr·
Fifth—Recantation of the chief judge and the jurors.—A general fast was appointed by the following proclamation, after the accusers had become so bold as to accuse even the wife of Gov. Phips.—
By the honourable the lieutenant governor, council and assembly of his majesty’s province of the Massachusetts-Bay, in general court assembled.
Whereas the anger of God is not yet turned away, but his hand is still stretched out against his people in manifold judgments, particularly in drawing out to such a length the troubles of Europe, by a perplexing war; and more especially respecting ourselves in this province, in that God is pleased still to go on in diminishing our substance, cutting short our harvest, blasting our most promising undertakings more ways than one, unsettling us, and by his more immediate hand snatching away many out of our embraces by sudden and violent deaths, even at this time when the sword is devouring so many both at home and abroad, and that after many days of public and solemn addressing him: and although, considering the many sins prevailing in the midst of us, we cannot but wonder at the patience and mercy moderating these rebukes, yet we cannot but also fear that there is
something still wanting to accompany our supplications; and doubtless there are some particular sins, which God is angry with our Israel for, that have not been duly seen and repented by us, about which God expects to be sought, if ever he turn again our captivity: Wherefore it is commanded and appointed, that Thursday, the fourteenth of January next, be observed as a day of prayer, with fasting, throughout this province; strictly forbidding all servile labour thereon; that so all God’s people may offer up fervent supplications unto him, for the preservation and prosperity of his majesty’s royal person and government, and success to attend his affairs both at home and abroad; that all iniquity may be put away, which hath stirred God’s holy jealousy against this land; that he would shew us what we know not, and help us wherein we have done amiss to do so no more; and especially that whatever mistakes on either hand have been fallen into, either by the body of this people, or any orders of men, referring to the late tragedy, raised among us by Satan and his instruments, through the awful judgment of God, he would humble us therefor, and pardon all the errors of his servants and people, that desire to love his name; that he would remove the rod of the wicked from off the lot of the righteous; that he would bring in the American heathen, and cause them to hear and obey his voice.
Given at Boston, December 12, 1696, in the eighth year of his Majesty’s reign
I A , Secretary.
“Upon the day of the fast, in the full assembly at the south meetinghouse in Boston, one of the honorable judges, [the chief justice Sewall] who had sat in judicature in Salem, delivered in a paper, and while it was in reading stood up; but the copy being not to be obtained at present, it can only be reported by memory to this effect, viz It was to desire the prayers of God’s people for him and his; and that God having visited his family, &c, he was apprehensive that he might have fallen into some errors in the matters at Salem, and pray that the guilt of such miscarriages may not be imputed either to the country in general, or to him or his family in particular.
“Some, that had been of several juries, have given forth a paper, signed with their own hands, in these words:
“We, whose names are under written, being in the year 1692 called to serve as jurors in court at Salem on trial of many, who were by some suspected guilty of doing acts of witchcraft upon the bodies of sundry persons:
“We confess that we ourselves were not capable to understand, nor able to withstand, the mysterious delusions of the powers of darkness, and prince of the air; but were, for want of knowledge in ourselves, and better information from others, prevailed with to take up with such evidence against the accused, as, on further consideration and better information, we justly fear was insufficient for the touching the lives of any, (Deut xvii 8) whereby we fear we have been instrumental with others, though ignorantly and unwittingly, to bring upon ourselves and this people of the Lord the guilt of innocent blood; which sin the Lord saith, in scripture, he would not pardon, (2 Kings, xxiv. 4) that is, we suppose, in regard of his temporal judgments. We do therefore hereby signify to all in general (and to the surviving sufferers in special) our deep sense of, and sorrow for, our errors, in acting on such evidence to the condemning of any person; and do hereby declare, that we justly fear that we were sadly deluded and mistaken; for which we are much disquieted and distressed in our minds; and do therefore humbly beg forgiveness, first of God for Christ’s sake, for this our error; and pray that God would not impute the guilt of it to ourselves, nor others; and we also pray that we may be considered candidly and aright, by the living sufferers, as being then under the power of a strong and general delusion, utterly unacquainted with, and not experienced in matters of that nature
“We do heartily ask forgiveness of you all, whom we have justly offended; and do declare, according to our present minds, we would none of us do such things again on such grounds for the whole world; praying you to accept of this in way of satisfaction for our offence, and that you would bless the inheritance of the Lord, that he may be entreated for the land.
Foreman, Thomas Fisk, Th. Pearly, sen, William Fisk, John Peabody, John Bacheler, Thomas Perkins, Thomas Fisk, jr, Samuel Sayer, John Dane, Andrew Eliot, Joseph Evelith, H Herrick, sen ”
Transcriber’s Notes:
Variations in spelling and hyphenation are retained. Perceived typographical errors have been changed
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