Suzanne Bassett advises life sciences, health care and consumer product companies on FDA-centric regulatory, enforcement and transactional matters, involving highly regulated products and emerging technologies. She helps clients navigate product development, approval, advertising and enforcement across FDA-regulated products, including overlapping federal jurisdictions and state law requirements, with additional experience involving the U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), U.S. Consumer Product Safety Commission (CPSC) and U.S. Customs and Border Protection (CBP).

Suzanne represents clients across a broad range of regulated products, including dietary supplements, cosmetics, foods, prescription and over-the-counter drugs, medical devices, consumer products, human cells, tissues and cellular and tissue-based products (HCT/Ps) and compounded drug products. She advises pharmacies, digital health platforms and other health care companies on FDA compliance, enforcement risk and evolving regulatory expectations related to compounding, advertising and distribution. She also advises companies developing digital health and technology-enabled products, including software-based medical technologies, clinical decision support tools and AI-driven health solutions, where regulatory oversight continues to evolve.

Suzanne’s advertising practice focuses on advising clients on marketing and promotional compliance under federal consumer protection law. She defends companies in FTC and National Advertising Division (NAD) challenges, as well as competitor disputes. She also counsels companies on advertising claim substantiation and compliance with FTC guidance governing health claims, environmental marketing, endorsements, consumer reviews and emerging digital health advertising practices. Suzanne combines her regulatory practice with health care litigation, representing clients in Administrative Procedure Act (APA) challenges to federal agency action. She has handled APA litigation involving FDA drug approvals and other health care regulatory issues, including disputes related to the 340B Drug Pricing Program.

Drawing on her scientific training in biochemistry and microbiology, Suzanne brings a unique, science-driven perspective to regulatory counseling and litigation. She is adept at translating complex scientific and technical concepts into practical legal strategies, allowing her to effectively assess regulatory risk, engage with agency expectations and advocate for clients operating at the intersection of science, technology and law.

Before joining Polsinelli, Suzanne gained several years of government experience at the FDA’s Center for Tobacco Products and the U.S. Department of Justice, Executive Office for United States Attorneys. Suzanne holds an undergraduate degree in biochemistry and pursued graduate level-training in  microbiology through the Integrated Graduate Program in the Life Sciences at Northwestern University’s Feinberg School of Medicine.

Outside of her legal practice, Suzanne is a competitive axe thrower and has competed in several disciplines at the World Axe Throwing Championships. She is one of the top-ranked female axe throwers in the world and one of only a few women to achieve professional status with the World Axe Throwing League.

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Education

  • American University, Washington College of Law (J.D., cum laude, 2016)
    • Syracuse University (B.S., magna cum laude, 2009)

      Bar Admission

      • District of Columbia
      • Virginia

      Court Admissions

      • U.S. District Court for the District of Columbia
      • U.S. Court of Appeals, District of Columbia Circuit
      Publications
      All Publications
      FDA Signals it Has No Appetite to Add Popular GLP-1 Drug Substances to the 503B Bulks List
      Key Takeaways FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. The proposal would materially limit 503B bulk compounding of these GLP-1 products. Comments on the proposal are due June 29, 2026. Bulk compounders should consider submitting comments that directly address FDA’s clinical-need framework, including patient safety considerations and any specific medical necessity for compounding these products from bulk drug substances. On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list via a Federal Register notice published on May 1, a move that, if finalized, would limit mass compounding of these substances by outsourcing facilities. FDA explained that, after reviewing nominations for semaglutide, tirzepatide and liraglutide, it found no demonstrated clinical need for outsourcing
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      Medspas on Alert: The FDA Says You’re a Dispenser Too
      Key Takeaways Medspas and other entities operating in the aesthetic space that dispense or administer prescription drugs should assess whether they have obligations as dispensers under the DSCSA and ensure they have policies, procedures and controls in place to demonstrate compliance with applicable requirements. To avoid the deficiencies cited in the warning letter, dispensers should focus on strengthening supply chain controls, maintaining complete product records and ensuring operational readiness for FDA inspection. Dispensers that receive a Form FDA 483 documenting observations of potential violations after an FDA inspection should act immediately to develop a thorough response with supporting documentation. On April 1, 2026, the FDA issued a warning letter to Pure Indulgence Aesthetics (Pure Indulgence), a Texas-based medical spa. Notably, this is the first
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