Hyman Phelps and McNamara
 
Dara Katcher Levy
Director
Photo of Dara Katcher Levy

(202) 737-4290
dlevy@hpm.com
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Practice Areas
Corporate Transactions
Advertising and Promotion
Training Programs

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

Bar Admissions
District of Columbia
New York

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Dara Levy specializes in advertising and promotion, import/export, and general food and drug law. She provides the regulatory and legal review function for small companies, and gives higher level advice to large companies with well-established legal departments.

Ms. Levy primarily counsels pharmaceutical and medical device clients on issues relating to the advertising and promotion of pharmaceutical drugs and devices. As part of this work, Ms. Levy evaluates marketing strategies and conducts company training programs on appropriate review procedure relating to marketing strategies and materials. Ms. Levy also acts as the legal reviewer on promotional review committees for branded pharmaceutical drugs and has been a reviewer for several launch campaigns. Beyond marketed product communications, Ms. Levy advises companies without currently marketed products on appropriate corporate communications relating to disease awareness and the company's pipeline.

In the import/export area, Ms. Levy 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, Ms. Levy worked in the Washington D.C. office of a major international law firm focusing on complex product liability litigation. Ms. Levy also worked on the Regulatory Staff of the Center for Devices and Radiological Health (CDRH) at FDA.


Related 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.


Articles / Publications   
•  Imported Products - FDA Is Not Fooling Around,  January 2009


Speaking Engagements   
•  ACI Import Compliance & Enforcement Conference, Panel member: "Importing FDA Regulated Goods: Satisfying New Safety Requirements and Agency Compliance Expectations", June 20 - 21, 2012
•  Pharmaceutical Compliance: Off-Label Drug Promotion Conference, Analyzing the Current Pharma Communication Landscape, November 8 - 9, 2010
•  FDA News Webinar, Direct-to-Consumer Broadcast Ads, June 9, 2010


Blog Posts   
•  Slower than Molasses in January, FDA Moves to Provide Guidance on Product Communications by Pharmaceutical and Device Manufacturers,  March 2, 2017
•  OPDP Doubles Enforcement Letters, But is Carefully Picking Its Battles,  January 19, 2017
•  Not Dead Yet – OPDP Issues Two Untitled Letters Late in the Year (Our 3,000th Post!),  December 18, 2016
•  FDA Electronic Registration for Human Drugs, Animal Drugs, and BLAs,  September 19, 2016d
•  “ACE” Is Here. Are You Ready? How FDA Intends to Help,  July 27, 2016