Overview
Attorney Megan Robertson approaches her practice with enthusiasm that stems both from her personal experiences and her overall passion for the intersection of science, medicine, and the law.
Her background, including an undergraduate degree in genetics, allows her to understand the unique compliance challenges faced by, and the development opportunities available to, companies in the life sciences industry. These include drug and device manufacturers, clinical laboratories, research sponsors, clinical research sites, and contract research organizations (CROs), among others. Megan also coordinates due diligence efforts on behalf of private equity firms to perform risk-based regulatory and compliance assessments of investments in these types of businesses.
Because she has dedicated a substantial portion of her practice to the laboratory industry, Megan is a co-lead of Epstein Becker Green’s Clinical Laboratories Focused Initiative. She regularly advises lab clients and stakeholders on state and federal compliance considerations; in particular, Megan is experienced in guiding clients through the development of direct access testing business models, including aspects such as corporate structure, risk management, and regulatory compliance.
In addition to her life sciences practice, Megan has worked closely with providers of Applied Behavior Analysis (ABA) services to individuals with autism spectrum disorder and previously interned with the advocacy group Autism Speaks. From these experiences, Megan has developed an understanding of the issues related to ABA billing and coding compliance, as well as certain nuances of contracting to provide such services to both private and government payers.
Megan also enjoys working on different pro bono and volunteer initiatives. For example, she is actively involved in Legal Aid DC’s annual Making Justice Real Campaign and represents clients in hearings in front of the Social Security Administration as part of the appeal process to secure disability benefits.
Focus Areas
Services
Industries
Trending Issues
Experience
- Coordinated a regulatory compliance due diligence review on behalf of a private equity firm of a global organization that offers research and development services and drug and biologic commercialization services. Megan worked with the Epstein Becker Green team, as well as international local counsel, to assess the various regulatory landscapes governing each arm of the target business, including, among others, Food and Drug Administration (FDA), CLIA, Physician Payments Sunshine Act, and licensure and accreditation considerations.
- Developed a clinical trial agreement (CTA) negotiation playbook on behalf of a pharmaceutical manufacturer and research sponsor. Megan worked closely with the client’s contract team to ensure the work product met their specific needs and highlighted the regulatory nuances of CTAs. Megan also regularly negotiates CTAs on behalf of clients in the clinical research industry.
- Performed a product labeling assessment for a client’s products containing cannabis and cannabis derivatives. Megan assisted in analyzing the products’ FDA regulatory classification, intended uses, claims, and compliance with federal and state labeling requirements in order to provide a thorough risk-based assessment of each product.
- Counseled a test developer on legal and regulatory compliance issues associated with laboratory developed tests. Megan assisted in assessing the test’s functional pathway to determine whether it was considered “direct to consumer,” associated state physician order requirements, informed consent considerations, and other considerations such as state laws governing retention and destruction of genetic material.
- Represented an ABA provider in a Defense Health Agency hearing to challenge the provider’s exclusion from TRICARE. Megan’s understanding of how billing and coding for ABA therapy has evolved over time, as well as the unique nature of the settings in which ABA can be provided, was instrumental in presenting the client’s case to the administrative law judge.
Recognition
- The Best Lawyers in America©: “Ones to Watch,” Health Care Law (2024, 2025)
Credentials
Education
- The George Washington University Law School (J.D., with honors, 2017)
- Concentration in Health Law
- Executive Editor, Federal Circuit Bar Journal
- Certified Student Attorney, GW Law Vaccine Injury Litigation Clinic
- Clemson University (B.S., magna cum laude, 2014)
Bar Admissions
- District of Columbia
- Maryland
Court Admissions
- Maryland Court of Appeals
Professional & Community Involvement
- American Bar Association
- American Health Lawyers Association
- Food and Drug Law Institute
- Legal Aid DC – Making Justice Real Campaign Co-Chair
- Seabury Resources for Aging - Young Professionals Board
Media
Events
Past Events
Insights
Insights
- Firm Announcements
Epstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 2025
14 minute read - BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices ...8 minute read
- BlogsMaking Moves – FDA’s LDT Proposed Rule Sent to OMB for Review2 minute read
- Media CoverageMegan Robertson Featured in “Women in STEM: The Stories of Five Women Scientists with Clemson Ties”4 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- Firm AnnouncementsEpstein Becker Green Awards 2023 Annual Core Values Champions4 minute read
- BlogsFDA LDT Webinar Serves as a Reminder to Industry to Submit Comments on the Proposed Rule3 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- BlogsFDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors4 minute read
- Firm Announcements
Epstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession
12 minute read - BlogsFDA’s LDT Proposed Rule Heads to the White House2 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New ...26 minute read
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
- Publications
Legal Landscape for Fertility Treatment in the U.S. in the Wake of Dobbs – Some Answers, More Open Questions. What Will ...
4 minute read - PublicationsIn Vitro Diagnostic (IVD) Devices2 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition6 minute read
- PublicationsHospitals and Hospital System Boards Should Review Sole Source Procurement Policies and Procedures2 minute read
- PublicationsCannabis Conundrum: Demonstrating “Accepted Medical Use” in a Restricted Research Environment2 minute read
- Media CoverageDelia Deschaine, Megan Robertson’s Thought Leadership on Cannabis Regulation Featured in Higher Law: “What’s Next ...3 minute read
- BlogsFDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review ...8 minute read
- BlogsFederal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears4 minute read
- PublicationsHow Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?3 minute read
- BlogsFDA Authorizes the First Home Collection of Specimens to Be Tested for COVID-192 minute read
- BlogsFDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic6 minute read
- BlogsFDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests2 minute read
- BlogsFDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic5 minute read
- PublicationsCBD DD: Key Considerations When Conducting Due Diligence on Cannabis Companies2 minute read
- BlogsAfter Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs4 minute read
- PublicationsTo Eat or Not to Eat: CBD "Edibles" Receive Mixed Reaction from States and Steady Opposition from FDA2 minute read
- BlogsFDA Hosts Long-Awaited Cannabis Public Hearing6 minute read
- PublicationsCBD Scrutiny May Signal Broader FDA Enforcement Trend3 minute read
- BlogsFDA Commissioner Gottlieb Says Agency Will Not Tolerate Deceptive Marketing of CBD Products; Issues Warning Letters ...3 minute read
- BlogsCBD “Edibles” Face Opposition from States, FDA4 minute read
- Media CoverageMegan Robertson, Lauren Farruggia Featured for FDLI Presentation on FDA Software Regulation2 minute read
- PublicationsOIG Portfolio Highlights Hospice Fraud and Quality-of-Care Concerns11 minute read
- PublicationsNew Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA11 minute read
- BlogsCheers to 80 Years: Celebrating the Anniversary of the Federal Food, Drug, and Cosmetic Act14 minute read
- PublicationsCheers to 80 Years of the Food, Drug, and Cosmetic Act1 minute read
- BlogsHHS OIG Inspector General Announces New Compliance Resource Portal2 minute read
- PublicationsObstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant ...11 minute read