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Stephanie Resnik is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device, Health Care, and Product Safety practice groups. Her practice focuses on advising pharmaceutical, medical device, biotechnology, tobacco, and children's product companies on a variety of regulatory and compliance issues, including advertising and promotion, fraud and abuse, facility registration, and federal and state reporting requirements. Ms. Resnik also advises pharmaceutical, dietary supplement, and tobacco companies on complying with the requirements of the Federal Hazardous Substances Act, the Consumer Product Safety Act, and the Poison Prevention Packaging Act, including child-resistant packaging requirements for prescription drugs and other FDA-regulated products.

  • Advise pharmaceutical company on mitigating risks associated with the Anti-Kickback Statute related to patient support programs and vendor contracts.
  • Assist pharmaceutical company with revising marketing and promotional materials in response to government investigation.
  • Provide risk assessment to pharmaceutical company regarding engaging in communications involving investigational products.
  • Draft guidelines for pharmaceutical company for proactive scientific exchange by company's medical professionals.
  • Advise drug and dietary supplement companies on reporting violations of the child-resistant packaging requirements to the CPSC.
  • Conduct regulatory due diligence for mergers, acquisitions, and public offerings involving pharmaceutical, medical device, and food companies.
  • Advise children's product companies on product safety compliance issues.
  • Prepare public comments to FDA on behalf of tobacco companies urging FDA to modify its interpretation and implementation of the Substantial Equivalence pathway for tobacco products.
  • Advise e-cigarette companies on risks of making claims on marketing materials under the Tobacco Control Act's modified risk provisions.

Pro Bono

  • Advised nonprofit organization on legal issues relating to Washington, DC’s status as a Sanctuary City.
  • Advised nonprofit organization on the authority of the Centers for Disease Control and Prevention (CDC) to research the causes and prevention of gun violence.