William A. Garvin
BIPC Logo

William A. Garvin

Shareholder

Washington, DC
 
 
 

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-head of the firm's cannabis 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 help-related products.

Since 2013, William has been consecutively named to the Washington, D.C. Super lawyers Rising Stars list.

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.

Before Buchanan

Before joining Buchanan, William was an associate with a boutique law firm in Washington, D.C., where he worked on matters related to ensuring that foods, drugs, dietary supplements, medical devices and cosmetics complied with federal and state laws.

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.
  • 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 on the regulatory status of electronic cigarettes and vaping products.
  • 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).
  • 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.
  • 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 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).