Dara Katcher Levy Director 202-737-4290
Dara Katcher Levy

Overview

Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications, marketing, and import/export.  Dara assists clients with products in all stages of development  to design engaging communications compliant with FDA legal and regulatory requirements.

In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective disease awareness initiatives.  At launch and in the post-marketing stage/environment, Dara works closely with corporate communications and marketing departments to help achieve their goals.

Dara serves as the legal reviewer on promotional review committees for branded products. Clients range from small start-ups to global Fortune 500 companies.

Dara has assisted on products ranging from orphan drugs to blockbuster pharmaceuticals, providing key support for successful launch campaigns, new marketing initiatives, social media and digital tactics, television advertisements and traditional healthcare professional and direct-to-consumer materials.  Dara also conducts company training programs on implementing effective promotional review procedures.

In the import/export area, Dara advises and represents U.S. and foreign-based companies before FDA on a range of issues including interpretations and appropriate responses to FDA Notices of Action, establishment registration and product listings, import for export, country of origin determinations, export certificates, and export of unapproved products.

Prior to joining the firm in 2001, Dara practiced in the Washington D.C. office of a major international law firm focusing on complex product liability litigation. Dara also worked on the Regulatory Staff of the Center for Devices and Radiological Health (CDRH).

Industries

Education & Admissions

Education

J.D., Fordham University School of Law
B.A., English and Philosophy, Politics, and Law, Binghamton University

Admissions

District of Columbia
New York

Experience

Advertising and Promotion

  • Advises clients on requirements pertaining to labeling and advertising claims in print and electronic/social media.

Serves as the legal and regulatory reviewer on product promotional review committees, assisting with new product launches and ongoing brand management.

Import/Export

  • Provides counsel to foreign and domestic companies on import-related enforcement actions, including responses to FDA Notices of Detention, Import Alerts, and FDA/customs releases.
  • Advises clients on issues pertaining to FDA registration and product listings for suppliers and importers of FDA-regulated products.
  • Assists companies on issues pertaining to the export of FDA-regulated products, including obtaining relevant export certificates.
  • Counsels companies on Country of Origin determinations as well as appropriate use of “Made in the USA” claims for products sold in the U.S.

Training

  • Assists in the development of standard operating procedures for the review and implementation of promotional materials.
  • Conducts training for pharmaceutical and medical device companies on promotional review processes and levels of evidence needed to support product claims.

Corporate Transactions

  • Provides guidance to companies involved in mergers and acquisitions or corporate restructuring to determine applicable changes to drug labeling, NDC numbers, and drug establishment registrations.
  • Assists in due diligence reviews of company promotional tactics and materials, identifying areas of risk.

Corporate Transactions

  • Provides guidance to companies involved in mergers and acquisitions or corporate restructuring to determine applicable changes to drug labeling, NDC numbers, as well as drug establishment registrations.
  •  Assists in due diligence reviews of company promotional tactics and materials, identifying areas of risk.
Education

J.D., Fordham University School of Law
B.A., English and Philosophy, Politics, and Law, Binghamton University

Admissions

District of Columbia
New York

Practice Areas
Industries
FDA Regulatory Categories