Download Marsha C. Wertzberger

ATTORNEY BIO
MARSHA C. WERTZBERGER
Marsha C. Wertzberger
Practices
Counsel
Washington, DC
202.857.6122
[email protected]
Food, Drug, Medical Device &
Agriculture
Industries
Marsha practices in the areas of food and drug law and
biotechnology, with a focus on regulatory and enforcement
matters, advertising and marketing issues, and product
development.
Client Work
Marsha specializes in regulatory and enforcement issues
involving foods, dietary supplements, drugs, and cosmetics,
including a variety of products derived from bioengineered crops.
She also advises on related advertising and marketing issues,
including e-commerce matters. In addition, Marsha focuses on
product development, including assisting clients with regulatory
strategies for positioning products and ensuring that safety and
claims substantiation testing will support the safety and efficacy
of the product. She also assists companies in preparing
regulatory submissions to the FDA, including New Drug
Applications, 510(k) Notifications, and food additive petitions,
and Generally Recognized as Safe (GRAS) Notifications.
Marsha also works with companies to develop safety and claims
substantiation testing packages. Finally, she advises companies
who are responding to enforcement actions by FDA and FTC.
Previous Work
Before joining Arent Fox, Marsha was a partner with the law firm
of McKenna & Cuneo. Previously, she was vice presidentinternational and associate general counsel for the Cosmetic,
Toiletry and Fragrance Association (CTFA), where she won the
American Society of Association Executive's Gold Circle Award
for developing CTFA's highly successful Anticounterfeiting
Program. Prior to working for CTFA, Marsha served seven years
in the Office of General Counsel of the US Food and Drug
Administration. She was counsel to the Center for Food Safety
and Applied Nutrition and, before that, counsel to the Over-theCounter Drug Division in the Center for Drugs and Biologics. She
twice received FDA's Award of Merit for food matters and also
received the Commissioner's Special Citation for her work with
OTC Drugs.
Before attending law school, Marsha worked as an economic
and market research analyst and professional education writer
for Merck, Sharp and Dohme in West Point, Pennsylvania.
Professional Activities
Marsha is active in mentoring activities within the firm and is a
founding member of the women in food and drug law group of
the Food and Drug Law Institute. The group was established to
promote mentoring, networking and marketing skills for women
in all phases of regulatory activities in FDA-regulated industries.
Publications, Presentations and Recognitions
Marsha is the author of two notable publications:
?Patient Package Inserts: Informed Consent to Drug
Therapy?,? Georgetown Law Journal; 1978 (Vol. 66, p.
837)
?Completing the OTC Process,? Food and Drug Law
Journal; 1980 (Vol. 35, p. 698)
Life Sciences
Areas of Focus
Cosmetics, Personal Care, &
OTC Drug Products
Food, Beverage & Dietary
Supplements
Pharmaceuticals & Biologics
1050 Connecticut Avenue, NW
Washington, DC 20036-5339
T 202.857.6000 F 202.857.6395
1675 Broadway
New York, NY 10019-5820
T 212.484.3900F 212.484.3990
555www.arentfox.com
West Fifth Street, 48th Floor
Los Angeles, CA 90013-1065
T 213.629.7400F 213.629.7401