William A. Garvin

William Garvin focuses his practice on issues related to the approval, regulation, promotion, sale and reimbursement of drugs, medical devices, biologics, excipients, dietary supplements and foods.

William assists clients in their interactions with various federal agencies including the following:

• Food and Drug Administration (FDA)
• Centers for Medicare & Medicaid Services (CMS)
• Drug Enforcement Agency (DEA)
• Federal Trade Commission (FTC)
• Health and Human Services (HHS)

William’s work includes challenging administrative agency actions through correspondence, citizen petitions and litigation. He has extensive experience in assisting companies with complying and contesting administrative agency actions and regulations at both the federal and state level.

Proof Points

• Since 2013, William has been consecutively named to the Washington D.C. Super Lawyers Rising Stars list.
• Member, Cannabis Committee, American Herbal Products Association
• Presented to NORML and FDLI regarding legal status of CBD
• Advised clients on the regulatory status of electronic cigarettes and vaping products.
• Counseled clients regarding the marketing of cannabis-related products.
• Successfully petitioned the DEA for the down-scheduling of a drug product.
• Assisted clients obtain research protocol approvals from DEA, FDA, and HHS for clinical trials of cannabinoids
• Advised clients regarding status of hemp and hemp oil products
• Reviewed and revised the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the FDA law and regulations.
• Assisted in successfully petitioning FDA to revise its exclusivity policy with regards to New Molecular Entity Exclusivity for combination drug products.
• Petitioned FDA to withdraw NDAs in accordance with FDA’s Application Integrity Policy.
• Petitioned FDA to require more information to demonstrate bioequivalence for new Abbreviated New Drug Applications (ANDAs) that utilize a complex innovator drug product as the reference listed drug (RLD).
• Negotiated with FDA and U.S. Customs to successfully remove import detentions on medical products.
• Drafted a response to FDA warning letters and worked with FDA to resolve issues cited in FDA warning letters.
• Assisted in litigation regarding a Paragraph IV certification and whether a generic drug is entitled to 180-day exclusivity.
• Assisted in providing input to members of Congress regarding proposed legislation and highlighting arbitrary enforcement actions by federal and state agencies.