James C. Shehan Senior Counsel

New York
T 646.414.6897 | F 973.597.2400



Clients rely on Jim for his expertise and his ability to help life sciences companies move their businesses forward. He is a seasoned health care executive and lawyer who brings to his practice vast experience in complex regulatory issues related to drug development and life cycle management, compliance matters, internal investigations, and transactions, including mergers and acquisitions and licensing matters.

Jim’s extensive pharmaceutical and health care industry expertise ranges from M&A, litigation, regulatory issues and intellectual property to securities and corporate governance. Known for his deep knowledge of FDA regulatory compliance, Jim is a trusted advisor to clients on issues related to the development and commercialization of pharmaceutical products, medical devices, and foods. He also has a deep understanding of the emerging field of biosimilars.

Prior to joining Lowenstein, Jim was of counsel at Hyman, Phelps & McNamara in Washington, DC. Previously, Jim was general counsel and head of government affairs and quality at Novo Nordisk, one of the most successful global health care companies. During his nearly 20-year tenure, Jim oversaw all legal issues and helped establish the company as the market leader in diabetes. He was also instrumental in the success of several other therapies. Additionally, Jim served as corporate counsel at Pfizer, where he advised management on various matters, including the company’s compliance with manufacturing, clinical and laboratory processes. At the start of his career, Jim was an associate in the FDA law group at Sutherland, Asbill & Brennan and worked at the FDA itself as a regulatory counsel in the office of the Associate Commissioner for Health Affairs.

A frequent writer and speaker, Jim is sought for his perspective on the regulatory, legal, and policy challenges shaping the global health care industry. He has spoken at various industry conferences in addition to congressional briefings and FDA public hearings.

Publications

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
Changes on the Horizon for Clinical Research and Drug and Device Development: 21st Century Cures Act Becomes Law
Life Sciences Client Alert, December 14, 2016
Michael Lerner, Tara D'Orsi, James Shehan
View More...

Press Mentions

Jim Shehan comments in Reuters on Trump Administration proposals for FDA deregulation. , Reuters , February 15, 2017
Jim Shehan comments in Law360 on the deluge of bold policy statements made by the FDA during the final days of the Obama administration. , Law360 , January 20, 2017
In Bloomberg Law, Jim Shehan comments on the importance of maintaining contacts for GCs returning to law firms. , Bloomberg Law , September 19, 2016

Related Areas

Corporate
Life Sciences

Education


Georgetown University Law Center ( J.D. , 1985 )
Columbia College, Columbia University ( B.A. , 1982 ) , Biology, French Concentration

Bar Admissions


New York
District of Columbia

Affiliations


  • Healthcare Institute of New Jersey (2005-2012, vice-chair 2012)
    • Trustee
  • Healthcare Leadership Council (2006-2012)
    • Board Member
  • American Friends of the Statens Museum for Kunst (Denmark’s National Gallery) (former Chairman)
    • Board Member
  • National Association of Manufacturers (2009-2012)
    • Board Member
  • PhRMA Law Section Executive Committee
    • Company Representative
  • BIO General Counsel Committee
    • Company Representative