Linda D. Bentley

Member

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(617) 348-1784 office phone

LDBentley@mintz.com email

One Financial Center
Boston, MA 02111

Linda chairs the firm’s FDA Practice Group and is a Member in the Corporate & Securities Section and the Life Sciences Practice Group. She has extensive experience representing pharmaceutical, biotechnology, and medical device manufacturers and insurers on corporate and regulatory matters.

Linda advises health products manufacturers on the regulatory and reimbursement status of products and procedures and on strategic pathways for bringing new products to market. She counsels clients on compliance with the Federal Food, Drug, and Cosmetic Act and related matters, such as arrangements for outsourced services, labeling and advertising, and requests for orphan drug and fast track designations. She also provides advice on the regulatory issues relating to in vitro diagnostic products, including laboratory developed tests and companion diagnostics. She performs regulatory due diligence for financings and other corporate transactions and counsels clients on disclosure of clinical and other product information. In addition, she has worked with companies to obtain reimbursement from insurance companies, managed care organizations, and Medicare.

She serves as general counsel to a large municipal self-insurance pool. She has also assisted insurance companies in obtaining initial state licensure, amendments to existing licenses, insurance department approval of mergers and acquisitions, and in responding to enforcements actions.

After graduating from law school, Linda served as senior counsel for the Massachusetts Division of Insurance, where she focused on the regulation of health insurance products and managed care organizations. She also advised the Commissioner of Insurance on insurance transactions, such as mergers and acquisitions, holding company filings, and agent, broker, and company licensing.

Before attending law school, Linda worked for eight years at New England Nuclear/DuPont Medical Products, where she served as director of regulatory affairs from 1976 to 1980. In that capacity, she established and implemented the company's FDA policy and was responsible for obtaining marketing approval for new products in the United States, Canada, and other countries. She continued to provide FDA consulting services to pharmaceutical and medical device companies while she was in law school.

Linda is admitted to practice in Massachusetts and is a member of the American Health Lawyers Association, the Massachusetts Bar Association, and the Boston Bar Association. She is a former director of the Massachusetts Medical Device Industries Council (MassMEDIC), a member of MassMEDIC's Advisory Committee on In Vitro Diagnostics, and a director of MedTech IGNITE—a MassMEDIC program for medical device entrepreneurs. She also is a member of the Advisory Board of BNA, Inc.’s Pharmaceutical Law & Industry Report. She has been recognized as a Massachusetts Super Lawyer, in a listing published as a special supplement to Boston Magazine, for many years, and is peer-review rated AV Preeminent by Martindale Hubbell.

Linda received her B.S. in Chemistry from Simmons College and her J.D. from Boston College Law School.

Publications

Author, “FDA Draft Guidance on In Vitro Companion Diagnostic Devices Provides an Outline but Few Specifics to Advance the Growth of Personalized Medicine,” Life Sciences/FDA Alert (07/22/2011)
Author, “New Guidance on RUOs and IUOs May Affect LDTs,” Life Sciences & FDA Alert (06/13/2011)
Quoted in “FDA Releases Strategic Priorities That Will Guide Agency Through 2015,” BNA’s Pharmaceutical Law & Industry Report (04/29/2011)
Author, “FDA Releases Criteria for Responsible Officer Prosecutions,” Life Sciences Alert (02/14/2011)
Quoted in “PLIR Advisory Board Sees Biosimilars, Enforcement Among Top Concerns for 2011,” BNA’s Pharmaceutical Law & Industry (01/21/2011)
Co-author, “New Proposed HIPAA Rules May Benefit Researchers,” Life Sciences Advisory (08/09/2010)
Co-author, “New Proposed HIPAA Rules May Benefit Researchers,” Health Law Advisory (09/09/2010)
Author, “Federal Funding Opportunity for Orphan Products,” Life Sciences Industry Extra (01/12/2009)
Co-author, “Radio Frequency Medical Devices: At the Intersection of FCC, FDA and Privacy Concerns,” FDLI Update (March/April 2007)
Co-author, “RFID Use in Health Care Raises Privacy Questions,” Boston Business Journal (11/17/2006)
Author, “Privacy Laws Affect Clinical Trials,” Mintz Levin Privacy Newsletter (09/01/2001)

Representative Speaking Engagements

“The Health Care Reform Law: Implications for the Medical Device Industry,” MassMEDIC Webinar, May 2010.
“Personalized Medicine: The Wave of the Future,” AdvaMED Annual Meeting, October 2009.
“Current Regulatory Hurdles Facing Start-Ups,” MedTech IGNITE Meeting, September 2009.
“The Rise of Personalized Medicine: Implications for the IVD Industry,” MassMEDIC Diagnostics Industry Update, March 2009.
“What Every SEC Lawyer Should Know about the FDA,” Mintz Levin program, February 2009.
“Voluntary Codes: Company Disclosure of Payments to Health Care Providers,” MassMEDIC Meeting on Codes of Conduct Laws, January 2009.
Panelist at U.S. China-India Innovation Partnerships Conference, December 2008.
“FDA Regulation of Diagnostic Tests” and “In Vitro Diagnostic Multivariate Index Assays: FDA Draft Guidance,” Presentations prepared for clients, 2008.
Panelist at Wireless-Life Sciences Alliance Meeting, May 2008.
“Conflicts of Interest in Drug Research,” Food and Drug Law Institute Annual Meeting, March 2008.
“Analyzing Project Management and Staffing Approaches,” American Conference Institute Seminar on Maximizing Sponsor-CRO Partnerships, June2007.
“Exploring the Regulatory Gray Area: Cosmeceuticals and Nutracosmetics,” American Conference Institute Seminar, May 2007.
“Clinical Trial Contracting Issues: Managing the Outsourced Relationship,” MassMEDIC Meeting, May 2007.
Chair, Drug/Device Summit, sponsored by BIO, AdvaMED, BIOCOM, and Windhover, December 2006.
Chair for Meeting on Evidence Based Medicine, MassMEDIC, April 2006.
“Navigating the Regulatory Minefield,” BioNova Meeting, Halifax, Nova Scotia, September 2005.
“Developing Improved Contract Negotiation Strategies for Outsourced Manufacturing,” IIR Conference, April 2005.
“Clinical Trial Agreements: Getting Your Agreement Right,” Canadian Consulate, Boston, April and June 2005.
“Genetic Tests, Pharmacogenomics and Drug Development,” BIO Annual Meeting, June 2004.

Admissions

Massachusetts

Education

Boston College
JD
Simmons College
BS

Publications

User Fees, Drug Shortages, Off-Label Issues Among PLIR Board's Top Concerns for 2012
Relocating Abroad
Life Sciences/FDA Alert: FDA Draft Guidance on In Vitro Companion Diagnostic Devices Provides an Outline but Few Specifics to Advance the Growth of Personalized Medicine
Life Sciences & FDA Alert: New Guidance on RUOs and IUOs May Affect LDTs
FDA Releases Strategic Priorities That Will Guide Agency Through 2015
Life Sciences Alert: FDA Releases Criteria for Responsible Officer Prosecutions
PLIR Advisory Board Sees Biosimilars, Enforcement Among Top Concerns for 2011
Life Sciences Advisory: New Proposed HIPAA Rules May Benefit Researchers
Health Law Advisory: New Proposed HIPAA Rules May Benefit Researchers
Life Sciences Industry Extra: Federal Funding Opportunity for Orphan Products
Communications and Health Care Article: Radio Frequency Medical Devices at the Intersection of FCC, FDA and Privacy Concerns
Privacy Article: RFID use in health care raises privacy questions.
Privacy Newsletter: Websites as Financial Institutions and Clinical Trials

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