William A. Garvin

How William Helps Clients

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

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 Administration (DEA)
• Federal Trade Commission (FTC)
• Health and Human Services (HHS)

William's experience includes reviewing and revising the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the FDA law and regulations. He works with clients to petition the FDA to ensure the safety and effectiveness of drug products on the market. He also assists in providing input to members of Congress regarding proposed legislation and highlighting arbitrary enforcement actions by federal and state agencies.

William is also co-leader of the firm's cannabis practice group, where he assists companies in navigating federal and state law issues related to the promotion and sale of cannabis-related products. William has helped companies work to bring FDA-approved cannabinoid drug products to market as well as helped clients navigate the sale of cannabis and hemp-related products.

William was consecutively named to the Washington, D.C. Super Lawyers Rising Stars list from 2013-2018. He also has been recognized as a Nationwide Cannabis Lawyer by Chambers USA from 2019- Present. 

What Clients Can Expect

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.

I help clients decipher the complexities of the federal regulations that affect their business.

Proof Points

• 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.
• Successfully appealed the denial of a Priority Review Voucher by the FDA for a Tropical Disease drug product resulting in the awarding and sale of the PRV worth over $80 million dollars.
• 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).
• Advised clients regarding cybersecurity requirements for medical devices.
• Advised clients on the regulatory status of electronic cigarettes and vaping products.
• Helped file user fee waivers and appeals to denials of user fee waivers.
• Counseled clients regarding the marketing of cannabis-related products.
• Petitioned FDA to recognize certain old drug products as being Generally Recognized as Safe and Effective (GRAS/E).
• Registered medical device companies and listed their products with the FDA.
• Ensured compliance with state and federal laws and regulations regarding the creation of Laboratory Diagnostic Tests (LTDs).
• Negotiated with FDA regarding the recall of a product found to be in violation of certain regulatory standards.
• Helped resolve threatened class actions involving allegations of false and misleading claims on food labels.
• Helped advise companies whether they would qualify for a Priority Review Voucher.
• Assisted in Lanham Act lawsuit against a competitor for making false and misleading advertising.
• Negotiated with FDA and U.S. Customs to successfully remove import detentions on medical products.
• Assisted in appeal to 11th Circuit regarding whether a package insert could be subject to Lanham Act litigation.
• 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 litigation to correct a patent listing within FDA's Orange Book.
• Successfully petitioned the DEA for the down-scheduling of a drug product.
• Prepared requests to FDA for orphan drug designations and minor use and minor species (MUMS) designations.
• Negotiated with CMS to obtain new codes for medical devices under the Healthcare Common Procedure Coding System (HCPCS).
• Reviewed and revised the labeling of drugs, medical devices, foods and dietary supplements to ensure compliance with the Federal Food, Drug and Cosmetic Act.
• Advised clients regarding threatened litigation and settlement for false and misleading advertisements under California Civil Code and California Business and Professional Code.
• Helped clients work with members of Congress so that they could provide input regarding proposed legislation and highlight arbitrary enforcement actions by federal and state agencies.
• Submitted Citizen Petition to clarify regulatory status of drug products that do not require prior approval because they are part of an unresolved Notice of Opportunity for a Hearing ("NOOH") under the Drug Efficacy Study Implementation ("DESI") Review Program
• Negotiated with CMS to obtain new codes for medical devices under the Healthcare Common Procedure Coding System (HCPCS).
• Provided counseling and helped draft responses to FDA warning letters.