Debra concentrates on food and drug law and Food and Drug Administration regulations governing human and animal pharmaceuticals and biologics, over-the-counter drugs, consumer health and pet care products, medical devices, digital health, food and beverages, cosmetics, and compounding pharmacy operations. Debra provides legal, regulatory and compliance advice to a broad range of FDA-regulated clients of all sizes and product development stages on matters involving clinical trials, pre-market regulatory enforcement, manufacturing, data integrity, advertising and promotion, supply chain, post-market compliance and risk assessment, agency interaction, and emerging regulatory issues.
Prior to her legal career, Debra Dunne was a registered pharmacist.
Debra has extensive experience in the legal and regulatory requirements of labeling, distribution, marketing and advertising. She has provided legal support for multiple product launches in many therapeutic areas. She counsels clients with pending product litigation in ongoing business matters, prepares citizen petitions, responds to FDA 483 observation letters, and provides legal review of corporate investor materials, press releases and media statements.
She brings a seasoned in-house counseling perspective to her practice, which includes the following areas:
Pharmaceuticals and Biologics
Debra provides the pharmaceutical and biotechnology industries with integrated counseling on legal, regulatory and compliance issues involving FDA drug approvals, risk evaluations and mitigation strategies (REMS), specialty and trade distribution, product development, clinical trial agreements, marketing and promotion, managed care agreements, HEOR, manufacturing, and supply chain trace and trace obligations under the Drug Quality and Security Act. Debra serves on client promotional and medical review committees and product launch teams for numerous brands in a variety of therapeutic areas, including endocrinology, gastroenterology, neurology, oncology, psychiatry, pulmonology and pain management. She counsels on emerging trends in sales and marketing and a range of legal, regulatory and operational challenges specific to the prescription drug industry. Debra has advised on many disease awareness regulatory strategies involving investigatory compounds. Debra also advises on the use of social media and digital health initiatives for drug product promotion. She has experience drafting and negotiating a wide range of complex commercial agreements involving anti-kickback and fraud and business issues, and has worked on FDA regulatory due diligence for acquisition targets and regulatory compliance audits of business practices.
Over-the-Counter Drugs and Consumer Health Products
Debra is a frequent speaker and author on over-the-counter regulatory issues. She advises on regulatory and commercial issues affecting the non-prescription drug and consumer health products industry, including regulatory strategy, labeling and marketing concerns related to drug monographs, New Drug Applications and prescription-to-over-the-counter switches. She also provides legal and regulatory review of over-the-counter print and digital advertising as well as risk assessments of claim substantiation. She provides legal counseling regarding consumer studies and the FDA’s NSURE initiative.
Medical Devices and Digital Health
Debra helps medical device and digital health companies anticipate, navigate and solve for FDA and FTC regulatory issues, integrating a cross-functional team of Shook attorneys to meet the specific needs of clients from startup companies developing medical mobile applications to mature companies working on cutting-edge innovations in health technology. She performs regulatory due diligence, writes opinion letters and citizen petitions, and prepares clients for agency interaction. Debra also counsels on in vitro diagnostics and laboratory developed tests.
Agribusiness, Food and Beverage and Dietary Supplements
Debra provides strategic, integrated counseling in complex legal and regulatory enforcement matters. She counsels pet and animal health care, food, beverage and dietary supplement companies on regulatory compliance in the areas of product labeling, health and nutrition advertising, product development, quality assurance and supply chain integrity. She has experience coordinating cross-functional teams to facilitate the development of adequately substantiated and compliant health, nutrition, natural and other food-related claims intended for use in print and digital product labeling and advertising for human and animal food. She advises and trains on emerging regulations, including the Federal Food Safety Modernization Act. Her experience includes counseling on FDA and USDA investigations and enforcement actions related to the food and beverage business, including advising on inspection readiness and product retrieval events such as recalls, withdrawals and safety alerts.
Debra counsels clients on cosmetic ingredient requirements, product labeling and enforcement issues. Her experience includes advising on anti-aging products, including labeling, claim substantiation, marketing and advertising and company media releases. She advises on importation, cGMP, distribution issues and a range of emerging regulatory concerns—including the use of nanomaterials in cosmetic products.
Pharmacy Operations/Compounding Pharmacy/Outsourcing Facilities
Debra leverages her pharmacy background to support her counseling of pharmacy operations. She advises on FDA and state enforcement issues, reporting requirements, labeling, distribution, and inspection readiness. She has experience advising 503 Outstanding Facilities on FDA 483 observation letters and adverse event and follow-up reports.
Publications and Presentations
Presenter, Introduction to Drug Law and Regulation, Regulation of Drug Manufacturing, FDLI/CDER In-House Training, November 2015
Presenter, Introduction to Drug Law and Regulation, Post Marketing Drug Issues, FDLI Drug and Medical Device Meeting, November 2015
Presenter, Good Promotional Practices Before & After Approval, Massachusetts Biotechnology Council, June 2015
Presenter, Social Media and New Forms of Advertising: Traps to Avoid, 4th Annual Legal, Regulatory and Compliance Forum on Over the Counter Drugs, American Conference Institute October 2015
Presenter, Good Promotional Practices Before & After Approval, MassBio Forum, June 2015
Presenter, FDA Regulatory, Policy, and Enforcement Development Key Trends in 2015, PDE Trade Organization, May 2015
Co-author, Analyzing Risk in Mobile Medical Apps, Update (Food and Drug Law Institute), November/December 2014.
Presenter, A New Era: FDA Regulatory Oversight of In Vitro Diagnostic Devices (IVDs) and Laboratory Developed Tests (LDTs), 2014 Regional Pharmaceutical: Medical Device CLE Seminar of the American Bar Association, October 2014.
Presenter, Modernizing the Monograph System and the OTC Drug Review Process; Seeking Clarity in Uncertainty, ACI’s 3rd Annual Legal Regulatory and Compliance Forum Over the Counter Drugs, October 2014.
Presenter, Biologics, Biosimilars and Beyond: Key Concepts, Regulatory Issues and Litigation Risks, American Bar Association and MassBio Inaugural Meeting, June 2014.
Presenter, Over-the-Counter (OTC) Drug Products, Food and Drug Law Institute’s Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, May 2014.
Co-author, Crafting Changes for the Future: The Use of Technology to Expand Access to Medications, Update (Food and Drug Law Institute), May/June 2014.
Presenter, Mobile Medical Apps and Unique Device Identifiers: Regulatory and Business Challenges, Food and Drug Law Institute Annual Conference, April 23-24, 2014.
Co-author, Crafting Changes for the Future: Increasing the Availability of Nonprescription Drugs, Update (Food and Drug Law Institute), March/April 2014.
Presenter, Regulatory Strategies for Life Science Companies, American Bar Association's Life Sciences Legal Summit, February 27, 2014.
Author, A Lesson for Objectors in Class Action Settlements, Law360, January 27, 2014.
Presenter, Over-the-Counter (OTC) Drug Products, Food and Drug Law Institute's Introduction to Drug Law and Regulation: The Legal Framework for Drug Regulation, November 22-23, 2013.
Presenter, How to Use Clinical Data and Results without Violating FTC Regulations: A Case Study on Omega-3 Claims, ACI 3rd Advanced Regulatory and Compliance Summit on Food & Beverage Marketing and Advertising, July 17-18, 2013.
Presenter, Regulatory Update, Shook, Hardy & Bacon 10th Annual Update of the Law CLE, June 2013.
Co-author, There's an App for That! – FDA Plans to Regulate Certain Mobile Medical Applications, imPACT Times, March 2012.
Co-author, The U.S. Supreme Court's Pliva, Inc., et al. v. Mensing Closes the Courthouse Door to People Who Take Generic Drugs – For Now, imPACT Times, September 2011.
Author, Three Years Later: Is REMS Reform Coming?, imPACT Times, October 2010.
Author, Unbranded Web Sites: FDA Finds Violative Promotional Practices, The National Law Review, October 2010.
Author, Truthful Prescription Drug Advertising and Promotion, Update Magazine, July/August 2010.
Presenter, Regulation of Drug Marketing and Drug Promotion: Are you Ready for Prime Time?, Food and Drug Law Institute's Introduction to Drug Law and Regulation, June 22-23, 2010.
Presenter, REMS Workshop, ACI Conference, April 21, 2010.
Presenter, Medical Device Off-Label Communications Primer, RAPS 2009 Annual Conference, September 13-16, 2009.
Presenter, Effectively Using Multiple Communications Channels While Controlling Off-Label Risks, ACI Conference, July 15, 2009.
Author, Legal Implications of Risk Management, Pharmaceutical Risk Management, August 2008.
Presenter, Minimizing the Potential for Off-Label Violations When Engaging in Risky Activities, American Conference Institute’s 5th Annual Pharmaceutical and Medical Device Counsel’s Guide to Off-Label Communications Conference, July 2008.
Presenter, Update on REMS, Center for Business Intelligence Webinar, June 2008.