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    Global Problem Solving from Covington: Deal with Complex Problems Anywhere in the World

    • Apr 08, 2021

Stephanie Resnik

Associate

Washington +1 202 662 5945

  • About
  • Representative Matters
  • Credentials
  • About

    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. Stephanie 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.

    Stephanie has experience counseling clients on interactions with federal and state regulatory agencies, including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), the Consumer Products Safety Commission (CPSC), and state Boards of Pharmacy.

    Stephanie regularly assists clients with preparing public comments for agency rulemakings and guidance documents. She also routinely provides regulatory advice and due diligence to support the corporate transactions of the firm’s life sciences practice.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • 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.

    Areas of Expertise

  • Credentials
    Education
    • The George Washington University Law School, J.D., 2012
        • with honors
        • The George Washington Law Review, Associate
    • University of Minnesota, M.F.A., 2007
        • Creative Writing
    • University of Wisconsin, B.A., 2003
        • with distinction
        • Phi Beta Kappa
    Bar Admissions
    • California
    • District of Columbia
    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.

    Areas of Expertise

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