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Innovator and Generic Drug Manufacturers: Implications of Legal, Regulatory and Political Updates on Safety Oversight, REMS and Product Liability Risk

Speaker(s): Howard L. Dorfman, Linda Pissott Reig
Recorded on: Oct. 17, 2017
PLI Program #: 229927

Linda Pissott 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.

Linda co-chairs the firm’s FDA Section. She joined Buchanan Ingersoll & Rooney after having previously served as a principal for a New Jersey–based law firm, and Vice President, Compliance Services of its pharmaceutical services subsidiary.

Linda counsels companies on lawful marketing and sale of FDA–regulated products. She reviews promotional materials (including broadcast ads, print materials, internet/social media) and evaluates marketing initiatives, such as physician speaker programs and patient support groups. For companies awaiting FDA approval, she provides guidance on lawful preapproval communication strategies.

In addition, Linda advises on compliance with industry standards for clinical trial set-up and oversight, including recruitment of investigators and subjects. She conducts compliance training for life sciences companies on compliance topics.

She prepares Standard Operating Procedures and Policies for corporate compliance programs, negotiates and drafts agreements and advises on consulting arrangements with key opinion leaders. In addition, she advises on pharmacovigilance, advisory boards, continuing medical education grants, charitable contributions and labeling changes. Linda guides companies on how to minimize legal risk while achieving business objectives.

On the state law side, Linda assists companies with their state law obligations, such as aggregate spend, marketing disclosures, data-mining, clinical trial disclosure, adherence to compliance codes, sales representative licensure and manufacturing/distribution licensure.

Linda serves as co-chair of the BioNJ Legal, Compliance and Regulatory Advisory Committee, which she was instrumental in forming in 2008. The committee is comprised of in-house counsel and compliance representatives from top-ranking NJ-based biotechnology companies who discuss new legal developments and put together programs of interest to the NJ-based biotechnology community.

With her broad base of knowledge of the life sciences industry, Linda brings experience with state and federal laws, including:

  • Patient Protection and Affordable Care Act of 2010
  • Food & Drug Administration Modernization Act of 1997
  • Food, Drug and Cosmetic Act
  • Anti-Kickback Statute & False Claims Act

Before joining Buchanan, Linda worked as in-house counsel (while on secondment) for a pharmaceutical company part-time for five years. While an associate, Linda litigated commercial disputes, as well as products liability/consumer fraud claims (both individual suits and class actions) arising from use of pharmaceuticals and medical devices. She served as a judicial clerk for the Hon. Marie L. Garibaldi, the first woman justice appointed to the New Jersey Supreme Court.

Linda's relevant reported cases include:

  • Thiedemann v. Mercedes–Benz USA, LLC, 183 N.J. 234, 872 A.2d 783 (2005)
  • West Morris Pediatrics v. Henry Schein, Inc., 385 N.J. Super. 581, 897 A.2d 1140 (Law Div. 2004)
  • Estate of Frankl v. Goodyear Tire & Rubber Co., 181 N.J. 1, 853 A.2d 880 (2004)
  • Erny v. Estate of Merola, 171 N.J. 86, 792 A.2d 1208 (2002)

Linda authored chapters in the Practicing Law Institute's Pharmaceutical Compliance and Enforcement Answer Book 2016 entitled "Risk Evaluation and Mitigation Strategies (REMS) and Related Post-Market Safety Oversight" and "Impact of FDA Regulatory and Compliance Oversight on Product Liability Exposure of Pharmaceutical Manufacturers".

Linda has garnered an AV® Preeminent certification from Martindale-Hubbell® Peer Review Ratings, the highest available mark for professional excellence. In 2007, Linda was recognized by the New Jersey Law Journal on its annual "40 Under 40" list. She was also selected for inclusion on the 2006–2008 New Jersey Super Lawyers® Rising Stars list, representing the top 2.5 percent of young attorneys practicing in New Jersey.



New Jersey Defense Association

President (2002–03), Executive Vice President (2000–02), Chairperson, Young Alumni Committee (1995–2000), Member, Executive Committee (1994–2003), Rutgers Newark College of Arts and Sciences Alumni Association

Chairperson, Constituents' Concerns Committee (2001–03), Representative (2000–03), Rutgers University Alumni Federation

Interviewer (1995–2003), Georgetown University Alumni Admissions Program

Member (2002–04), Georgetown Club of Northern New Jersey

Georgetown National Law Alumni Board

New Jersey Women Lawyers Association

Co-chair (2005), National Forum on Off-Label Promotion of Pharmaceuticals


  • Georgetown University Law Center, J.D., cum laude, 1993
  • Rutgers University, B.A., English, summa cum laude, Phi Beta Kappa, 1990, Newark College of Arts and Sciences


  • New Jersey
  • U.S. District Court for the District of New Jersey
  • New York
  • Supreme Court of the United States

Howard L. Dorfman is the founder of H.L. Dorfman Pharmaceutical Consulting which provides compliance, regulatory and risk management consulting services to pharmaceutical and biotech companies. 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 a Swiss-based global pharmaceutical and biotech company. Previously, he servedas 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 licensing, 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). First, as Counsel for litigation, he oversaw and directed nationwide mass tort litigation involving hormones, antibiotic (tetracycline), and medical device (silicone implant) products. Later, he became Counsel to the company’s U.S. Medicines Group, where he was responsible for the legal functions relating to the two largest prescription pharmaceuticals in the Bristol-Myers cardiovascular franchise. Mr. Dorfman has knowledge of the PhRMA Code, Office of the Inspector General (OIG) compliance, and FDA-related legislation as well as federal and state fraud and abuse regulations and statutes. He established OIG compliance procedures at a major pharmaceutical company while counseling on Medicare, Medicaid, and other healthcare reimbursement matters. Liaising with international stakeholders, he has developed FDA risk management plans and global drug labeling protocols in accordance with U.S. regulatory standards. He has lectured and published articles on a range of product liability and FDA regulatory issues. Mr. Dorfman received his B.A. with honors from Yeshiva University and his J.D. from Brooklyn Law School.