Katy Van Pelt is a Partner in the firm’s Regulatory, Food & Drug, Healthcare, and Life Sciences practice groups.  She provides advice on a range of regulatory issues relevant to manufacturers of prescription drugs, medical devices, in vitro diagnostic products, analyte-specific reagents, laboratory developed tests, infant formula, and food.

Her practice includes counseling on issues relating to advertising and promotion, where she works with clients to maximize the effectiveness of compliant advertising campaigns in all forms of media.  Ms. Van Pelt also advises manufacturers on the creation of and boundaries associated with non-promotional communications, including for products in development, and on the use of scientific exchange, interactions with health care professionals, scientific and educational grants and health economic data.  In addition, Ms. Van Pelt advises on issues related to clinical trials, pharmacovigilance, adverse event and MDR reporting, risk mitigation, product packaging, and quality issues such as 483 responses, field alerts and product recalls.

REPRESENTATIVE EXPERIENCE

  • Counsel device manufacturer on the creation of a CLIA laboratory, including development of a compliance policy for the laboratory.
  • Draft policies and procedures for compliant advertising, promotion and other communications by FDA regulated industries.
  • Counsel infant formula manufacturer through transition to non-BPA packaging.
  • Prepare and perform extensive training for employees of pharmaceutical, device and nutrition manufacturer, including on topics such as careful communications, compliant advertising and promotion, and the appropriate role of the scientific function.
  • Engage with FDA as well as directly with competitors to address non-compliant communications.
  •  Provide legal support to the client’s sales and marketing groups for products including Rx drugs, infant formula, nutrition bars, diagnostics, and diabetes blood glucose monitors and strips.
  • Advise clients for the above listed products on federal and state laws applicable to the use of print ads, social media (websites, twitter, facebook), television commercials, marketing plans, and compliance training.
  • Engage in discussions and correspondence with competitors and FDA regarding marketing disputes.

PREVIOUS EXPERIENCE

  • Abbott Laboratories, Counsel
  • Sidley Austin LLP, Associate
  • Wiley Rein, LLP, Associate

HONORS AND AWARDS

  • Member of the Abbott Laboratories Legal Department in 2012 when the department was awarded “Best Legal Department” by Corporate Counsel

PRO BONO AND COMMUNITY INVOLVEMENT

  • Abbott Pro Bono Committee, Chair (2012-2014)
  • Represented plaintiffs in discrimination lawsuit against restaurant

MEMBERSHIPS AND AFFILIATIONS

  • Board Member, Lake Bluff Alliance for Excellence

Education

  • College of William and Mary School of Law, J.D., 2004
    Member, William and Mary Law Review
  • University of Wisconsin, Madison, B.A., 2000

Admissions

  • Illinois
  • District of Columbia
  • Virginia