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 food, drug, device, dietary supplement and cosmetic issues, as well as matters related to 503B outsourcing facilities operating pursuant to the Drug Quality and Security Act (DQSA), and entities subject to the Drug Supply Chain Security Act (DSCSA). She also has experience assisting clients with matters related to the U.S. Department of Agriculture (USDA) and Drug Enforcement Agency (DEA) compliance. In addition, Lindsay helps pharmacy, wholesaler and third-party logistics provider clients navigate state licensing and pharmacy practice act issues. Her background also includes counseling clients on data privacy and security matters, fraud and abuse, and Medicare Part D.

Select Experience

  • Advises food and dietary supplement manufacturers related to transactional and compliance matters, including registration, labeling, advertising, inspections, recalls, and FDA and USDA enforcement actions.
  • Advises medical device manufacturing companies on registration, compliance, import and export issues, and 510(k) submissions.
  • Advises registered 503B outsourcing facilities on compliance with DQSA and state licensing issues.
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Experience

  • Advises food and dietary supplement manufacturers related to transactional and compliance matters, including registration, labeling, advertising, inspections, recalls, and FDA and USDA enforcement actions.
  • Advises medical device manufacturing companies on registration, compliance, import and export issues, and 510(k) submissions.
  • Advises registered 503B outsourcing facilities on compliance with DQSA and state licensing issues.
  • Advises pharmacy, wholesaler and third-party logistics provider clients on state licensing issues and compliance with state pharmacy practice laws.
  • Counsels clients on issues related to FDA compliance and enforcement, including FDA inspections, 483s, untitled letters, warning letters, recalls and consent agreements.
  • Drafts and negotiates pharmacy benefit management agreements and pharmacy participation agreements.
  • Counsels clients on pharmaceutical issues including drug pricing and Medicare Part D. 
  • 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.

Recognitions and Memberships

Recognitions

  • Chambers USA – Healthcare: Associate to Watch
    Pharmaceutical/Medical Products Regulatory in the District of Columbia (2018)
  • Chambers USA – Healthcare: Associate to Watch
    Pharmaceutical/Medical Products Regulatory in the District of Columbia (2017)

Memberships

  • American Health Lawyers Association
    • Young Professionals Council: Co-Chair (2018)
    • Young Professionals Council: Vice Chair (2017 to 2018)
    • 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

  • Member of a team of attorneys challenging the conviction of a death row inmate on habeas corpus grounds.
  • Acted as one of the primary drafters of a disabilities rights resource guide, as well as a resource guide for free medical clinics, in conjunction with the American Health Lawyers Association Public Interest Section.
  • Successfully negotiated the settlement of two appeals for disability benefits before the Department of Veterans Affairs on behalf of a veteran.
  • Represented an individual before the Social Security Administration to successfully obtain disability benefits.
  • Successfully negotiated an Individualize Education Program (IEP) for a local student.

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