Mark is a member of the firm’s FDA Regulatory practice. He has more than 30 years’ experience representing U.S. and international clients in the pharmaceutical, medical device, food and beverage, dietary supplement, and consumer products sectors. Earlier in his career, Mark served at the Federal Food and Drug Administration (FDA). Today, he draws on his substantial experience to provide clients with practical, actionable advice to help them navigate the complex regulatory landscape.
Mark focuses his practice in several distinct areas, including:
- Synthetic Pharmaceuticals
- Medical Devices
- Conventional Foods
- Dietary Supplements
Mark assists regulated companies with the FDA approval and clearance process for drug products, diagnostics, medical devices, and food ingredients. He also helps clients with regulatory compliance and enforcement issues involving product status issues, labeling, advertising, and current good manufacturing practice laws and regulations cGMPs). This includes responding to FDA Warning Letters, adverse inspection observations, product seizures, import alerts, product detentions, recall requests, and consent decrees.
Additionally, he counsels clients on FDA due diligence regarding portfolio companies for investor groups and acquiring companies, and has reviewed and revised the FDA regulatory sections of numerous securities filings. Mark also drafts and negotiates agreements specific to FDA-regulated industries, such as collaboration licensing, supply, and clinical trial agreements.
Besides representing clients in FDA matters, Mark represents companies before a number of other federal administrative agencies including the Federal Trade Commission (FTC), Environmental Protection Agency (EPA), Consumer Product and Safety Commission (CPSC), and the National Advertising Division of the Better Business Bureau (NAD). He is experienced in assisting clients with advertising claims and substantiation issues, as well as compliance with the Federal Trade Commission Act.
Before joining the firm, Mark was a partner in the Washington, D.C. office of a large national law firm.