Lindsay P. Holmes

Associate

Washington, D.C.
T +1.202.861.1746
F +1.202.861.1783

Overview

Lindsay Holmes focuses her practice on regulatory and transactional matters primarily in the healthcare and life sciences industries. She has experience advising clients on Food and Drug Administration (FDA) regulatory matters including drug, device, dietary supplement and cosmetic issues, as well as matters related to 503B outsourcing facilities and the Drug Quality and Security Act (DQSA). She also helps pharmacy clients navigate state licensing and pharmacy practice act issues. Additionally, Lindsay has experience counseling clients on data privacy and security matters, fraud and abuse, and Medicare Part D.

Select Experience

  • Working with business associates and covered entities, has drafted data privacy-related agreements, including business associate and data use agreements, and website terms of use and privacy policies.
  • Has drafted website terms of use and privacy policies for clients engaged in medical tourism. 
  • Has drafted Health Insurance Portability and Accountability Act policies and procedures for healthcare clients, including covered entities and business associates
More »

Experience

  • Working with business associates and covered entities, has drafted data privacy-related agreements, including business associate and data use agreements, and website terms of use and privacy policies.
  • Has drafted website terms of use and privacy policies for clients engaged in medical tourism. 
  • Has drafted Health Insurance Portability and Accountability Act policies and procedures for healthcare clients, including covered entities and business associates.
  • Has drafted evidence of coverage documents and insurance applications for compliance with federal and state insurance laws for an insurance company.
  • Analyzed anti-kickback liability for a physician fee-splitting arrangement and a laboratory discount program.
  • Has counseled human and veterinary pharmaceutical and food manufacturers on issues related to FDA application submissions and import/export customs issues.
  • Works with medical device manufacturing companies on import, export and 510(k) issues.
  • Advises registered 503B outsourcing facilities on compliance with DQSA and state licensing issues.
  • Advises pharmacy clients on state licensing issues and state practice of pharmacy laws.
  • Drafts pharmacy benefit management agreements and pharmacy participation agreements.
  • Counsels clients on pharmaceutical issues including drug pricing and Medicare Part D. 

Recognitions and Memberships

Recognitions

  • Chambers USA: Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia (2017)

Memberships

  • American Health Lawyers Association
    • Young Professionals Council: Member (2016 to 2017)
    • Young Professionals Council: Social Media Coordinator (2015 to 2016)
  • Bar Association of the District of Columbia: Health Law Section
  • American Society of Pharmacy Law
  • Food and Drug Law Institute

Pro Bono

  • Worked on a disabilities rights resource guide as well as a resource guide for free medical clinics as part of the American Health Lawyers Association Public Interest Section.

Prior Positions

  • Squire Patton Boggs
  • DrFirst Inc.: Member of In-House Legal Department

Admissions

  • District of Columbia
  • Florida

Education

  • LL.M., Law and Government, American University, 2014; Certificate in Health Law and Policy; Certificate in Administrative and Regulatory Law
  • J.D., University of Miami School of Law, 2011, cum laude
  • B.B.A., University of Miami, 2009