Tara P. D'Orsi Senior Counsel

New Jersey
T 973.597.6202 | F 973.597.6203



Tara’s practice is focused on the life sciences industry. She has extensive experience with the laws and industry standards that apply to the sales and marketing of pharmaceuticals and clinical development programs. A problem-solver, Tara is particularly effective at giving her clients the practical advice they need to minimize risk and achieve their business objectives. They value her knowledge of the industry, her tenacity, and her collaborative approach to working with complex, cross-functional teams.

Tara advises biotech and pharmaceutical companies on compliance issues related to advertising and promotion, pre-approval communications, fraud and abuse, interactions with health care professionals, managed markets, federal and state transparency reporting regulations and aggregate spend, sample accountability, and other aspects of federal and state regulation of pharmaceuticals. She is well-versed in drafting agreements for various customer segments, including specialty pharmacies, pharmacy benefit managers, group purchasing organizations, wholesalers, integrated delivery networks, distributors, third-party logistics providers, and other third-party service relationships. Tara works closely with her clients to review promotional materials for U.S. Food and Drug Administration (FDA)-regulated products, evaluate marketing initiatives, and draft the accompanying service agreements. She also drafts standard operating procedures for corporate compliance programs, provides company training on corporate compliance, and assists with investigations of compliance issues.

In addition to compliance and commercial activities, Tara assists clients in lawfully establishing their clinical trial programs. She has extensive experience negotiating the various agreements relevant to a clinical development program, including agreements with contract research organizations, clinical trial sites (including U.S. government Cooperative Research and Development Agreements (CRADAs)), laboratory services, manufacturing, packaging, drug storage and shipment, meeting logistics, and other necessary vendor services. She advises clients on compliance with FDA regulations and Good Clinical Practices, global clinical trial setup, privacy regulations, and oversight of the clinical trial process.

As a former in-house counsel in the pharmaceutical and hospital industries, Tara has a deep understanding of the practice of health care and the inner workings of the pharmaceutical industry. Her strong knowledge of the life sciences sector has given her the right insights to navigate evolving market challenges and craft legal advice that supports her clients’ business objectives.

Prior to joining Lowenstein Sandler, Tara served as General Counsel of Robert Wood Johnson University Hospital Rahway, which had a 200-bed acute care hospital, a skilled-nursing facility, a hospice, and an ambulatory care facility.

Tara also spent six years as Senior Counsel at Reliant Pharmaceuticals, one of the nation’s largest privately held pharmaceutical companies (acquired by GlaxoSmithKline in 2007). During her tenure, she successfully led legal affairs for the launch of the first FDA-approved prescription omega-3 and had significant responsibility for the development and management of Reliant’s corporate compliance and sample accountability programs. She supported the clinical development teams and the sales and marketing department, and was responsible for all legal support including drafting of contracts, legal representation on the promotional review team, and application of various state and federal regulations on operations for the company’s branded products.

Other Distinctions

  • Healthcare Business Women's Association Rising Star Award, 2000

  • Adjunct Professor of Law at Seton Hall University School of Law, 2001-2002 - Developed course materials and taught "Not-for-Profit Health Care Organizations" and "Representing the Pharmaceutical Client."

Publications

Reviewing Changes Made by the 21st Century Cures Act to Drug and Device Development
Westlaw Journal Pharmaceutical, April 2017
James Shehan, Tara D'Orsi, Donna Hanrahan
FDA Breaks Medical Product Communications Silence
Law360, January 27, 2017
James Shehan, Tara D'Orsi, Donna Hanrahan
With a Whisper, Not a Shout, FDA Breaks Silence on Medical Product Communications
Life Sciences Client Alert, January 24, 2017
Tara D'Orsi, James Shehan, Donna Hanrahan
View More...

Press Mentions

Lowenstein Sandler represented Pernix Therapeutics Holdings Inc. in its acquisition of the Zohydro® ER Franchise from Zogenix Inc. Under terms of the agreement, Pernix, through its wholly-owned subsidiary, Ferrimill Limited, paid Zogenix $70 million in cash, issued to Zogenix 1,682,086 shares of Pernix common stock and deposited an additional $10 million in cash in escrow to fund potential indemnification claims for a period of 12 months following the closing. Pernix also purchased certain Zohydro ER inventory. The Lowenstein deal team is led by Michael Lerner, Herschel Weinstein, and Park Bramhall, and also included Lowell A. Citron, Marc Kurzweil, Brian A. Silikovitz, Christina Iafe, Jack D. Sidorov, Jeffrey M. Shapiro, Hilla Shimshoni, Tara P. D'Orsi, Michael Amalfe, Sarah Saladini and Eugene Cheval. , April 24, 2015

Related Areas

Life Sciences

Education


Seton Hall University School of Law ( J.D. , 1996 ) , cum laude; Member, Legislative Law Journal
Lehigh University ( B.A. , 1993 ) , with honors

Bar Admissions


New York
New Jersey

Court Admissions


U.S. District Court, District of New Jersey