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Pharmaceutical Industry and the Current Regulatory, Compliance and Liability Environment: What’s Keeping Manufacturers Awake at Night?


Speaker(s): Howard L. Dorfman, Linda Pissott Reig, Vicky G. Gormanly
Recorded on: Jul. 14, 2016
PLI Program #: 187626

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.

Practices

Affiliations

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

Education

  • 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

Admissions

  • 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.


Vicky Gormanly is an Associate in the FDA and Healthcare group in the New York office, 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 (for example, Medicaid Drug Rebate Program, 340B, Tricare, State Pharmaceutical Assistance Programs, State Supplemental Rebate Programs, Medicare and Medicaid reimbursement, Anti-Kickback Statute), as well as product coverage, coding, payment, and reimbursement issues. 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 health care 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.

Experience

Life Sciences and Healthcare Regulatory

  • Advises pharmaceutical manufacturers on drug pricing issues under the 340B program, Medicaid, Medicare, and the Department of Veterans Affairs healthcare program; prepares drug price reporting policies and reasonable assumptions; provides guidance on internal audits and price recalculation projects.
  • Counsels pharmaceutical manufacturers on compliance with federal laws relating to healthcare fraud and abuse, including the Anti-Kickback Act and the False Claims Act.
  • Drafts comments to CMS and other HHS agencies on behalf of drug manufacturers and industry associations on proposed rules and guidance regarding drug reimbursement and price reporting issues.
  • Advises pharmaceutical manufacturers on coverage and reimbursement issues relating to Medicaid and Medicare.
  • Counsels pharmaceutical manufacturers on implementation of recent health care reform legislation.


Perspectives

 
April 1, 2016
CMS Delays Enforcement of 5i AMP Provisions
Legal Alert

January 25, 2016
CMS Releases Final Medicaid Rebate Rule
Arnold & Porter Advisory

December 1, 2015
Pharmaceutical and Medical Device Compliance Update: Management of Critical and Emerging Legal Challenges
Arnold & Porter Seminar/Conference

September 1, 2015
HRSA Issues Proposed "Omnibus 340B Guidance"
Arnold & Porter Advisory

June 18, 2015
HRSA Issues Proposed Rule on 340B Ceiling Price Calculations and Manufacturer Civil Monetary Penalties
Arnold & Porter Advisory

July 29, 2013
HRSA Issues Final Rule on Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program
Arnold & Porter Advisory

Credentials

Education

  • JD, Pace Law School, 2009, cum laude
  • BS, Post University, 2005

Admissions

  • New York
  • District of Columbia
  • Connecticut

Focus Areas

Life Sciences and Healthcare Regulatory
Pharmaceutical/Medical Device