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

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

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

Court Admissions

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

Insights

Insights

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