J. Mason Weeda*'s Profile Image

J. Mason Weeda*

Phone: (202) 789-1212
Fax: (202) 234-3550

Mason Weeda is a principal with OFW Law and devotes his practice to a blend of matters, principally representing FDA regulated medical device, drug, and food manufacturers, distributors, and importers. In addition, Mason provides counsel to trade associations and commodity groups that include FDA or USDA regulated industry. Mason also has an expertise in advising software and application developers, particularly where “protected health information” is used, stored, or disclosed under HIPAA, or where such software or applications include promotion of FDA regulated products.

Mason advises clients principally in the following areas:

  • FDA regulated product applications and approvals, ranging from Premarket Clearance (510(k)) applications for medical devices, to Drug Master Files for drug-related products, to Temporary Marketing Permits for foods
  • FDA and USDA enforcement and administrative matters including, without limitation, counsel regarding Warning Letters, Complaints for Injunctive Relief and Consent Decrees, Citizen Petitions, and Trade Complaints
  • FDA and FTC promotion and advertising compliance, including promotion of medical devices and drugs (e.g., “off-label promotion”), and compliance with Federal Anti-kickback Statute, Sunshine Act, CAN-SPAM, other laws that may apply to advertising and promotion of FDA-regulated products
  • Legislative and regulatory policy strategy, including comments on relevant rulemaking and agency guidance
  • Import issues involving FDA and USDA regulated products, including import alerts, holds, detentions, and refusals, and Customs and Border Protection petitions regarding liquidated damages
  • Compliance with FDA Food regulations, including food labeling, dietary supplement promotion, formulation and ingredients, and FSMA requirements, including preventive controls
  • Compliance with the Health Insurance Portability and Accountability Act (HIPAA), including breach reporting, Business Associate Agreements, Privacy and Security Rule compliance, regulatory audits, and HHS enforcement.
  • Qui Tam (False Claims Act) defense
  • Trade association governance and general counsel
  • Regulatory due diligence opinions regarding the purchase or merger of a FDA or USDA regulated entity or product

In addition to the above, Mason teaches Food and Drug Law to new employees at FDA’s Center for Device and Radiological Health, and is a frequent presenter at local and national symposiums and trade events.

Mason previously worked in sales and marketing for a biologics manufacturer and a laboratory that provided neuro-genetic diagnostic testing. After law school, he was law clerk to The Honorable Terrence J. McGann, of the Circuit Court for Montgomery County, Maryland, where he was provided with vast exposure to litigation. Mason then specialized in civil litigation at a boutique law firm in Maryland before joining OFW Law. Mason’s blend of experience in sales and marketing and litigation affords him a unique and beneficial perspective in assessing and resolving regulatory matters.

Mason was born and raised in the Washington, D.C., metropolitan area. He is a graduate of Gonzaga College High School in Washington, D.C. He later received his Bachelor of Arts degree in English from Fairfield University in 2001, and his Juris Doctorate from the University of Baltimore in 2009. Mason is a member of the Health and Agriculture Law Sections of the Maryland State Bar Association, the Food and Drug Law Institute and the American Health Lawyers Association.

Bar and Court Admissions

  • U.S. District Court District of Maryland
  • Maryland

* Practice within the District of Columbia is limited to matters and proceedings before Federal courts and agencies.

Education

  • University of Baltimore School of Law, J.D., 2009
    Student Fellow
  • Fairfield University, Fairfield, Connecticut, B.A. English, 2001
    Concentrations in Marketing and Communications

Special Agencies

  • The Food and Drug Administration
  • Health and Human Services, Office for Civil Rights
  • Federal Trade Commission
  • Department of Agriculture

Publications

  • The Food Institute, “U.S. Food Labeling Guide” (2018)
  • FDLI, "Bringing Your Pharmaceutical Drug to Market" (April 2015)

Honors and Awards

  • Washington D.C. Super Lawyers Rising Stars, 2013 - 2019
  • Martindale-Hubbell Client Distinction Award, 2012

Browse Mason Weeda's posts on the Ag/FDA Blog