PARTNER
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Phone 202-223-5120
Fax 202-223-5619
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Stacy Ehrlich is a partner who has been with the firm since 1996. Her practice focuses primarily on representing pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device companies on a variety of matters involving FDA, USDA, and the FTC, as well as state agencies. Ms. Ehrlich has substantial expertise with regard to product approvals, promotion and substantiation, OTC switches, drug exclusivity, online pharmacy and compounding, medical foods, privacy issues, food safety and ingredients, and corporate compliance. She regularly counsels clients with regard to labeling and advertising, import and export issues, clinical trials, and due diligence matters. Ms. Ehrlich is currently outside counsel for the Council of Independent Tobacco Manufacturers of America and has been involved in FDA's regulation of tobacco products since early in the legislative process of the Family Smoking Prevention and Tobacco Control Act.
Ms. Ehrlich has over 15 years of experience in FDA law and related issues and has made presentations and authored articles relating to various issues of food and drug law, including OTC drug labeling, the PDMA, liquid dietary supplements, corporate compliance, drug exclusivity, and tobacco product regulation and enforcement. She has additionally authored chapters in the Food and Drug Law Institute (FDLI) publications, How to Work with the FDA and TOP 20 FOOD AND DRUG CASES, 2010 & CASES TO WATCH, 2011. Ms. Ehrlich currently serves on the FDLI Tobacco Committee and as an Advisory Board Member for Keyvive, a diabetes lifestyle Internet-based business venture.
Prior to joining KKB, Ms. Ehrlich clerked for the Honorable Alexander B. Denson of the Eastern District of North Carolina and practiced food and drug law at a large DC-based law firm.
matters
- Conducted internal investigations on behalf of pharmaceutical companies regarding compliance with federal law
- Participated as the legal representative on the promotional review committees of large pharmaceutical companies
- Assisted trade association in drafting provisions for inclusion in the Family Smoking Prevention and Tobacco Control Act (TCA) that would protect the interests of small businesses, and counseled the association members regarding submitting the draft provisions to their legislators
- Represented the underwriter in an Initial Public Offering for a biopharmaceutical company seeking funding to continue development of its investigational drugs and to submit its first New Drug Application to the FDA
- Prepared comments and correspondence to FDA on behalf of a trade association regarding FDA's regulation of tobacco products
- Assisted medical device companies in obtaining 510(k) clearance for a number of products, including a dental software device, a hemorrhoid relief device, and a spinal mobilization device
- Participated in the development and implementation a successful switch of a drug product from prescription to OTC status and the securing of 3 year market exclusivity
- Assisted clients in the preparation and filing of trade complaints with FDA and other regulatory bodies that resulted in enforcement action against the products or practices at issue
- Assisted a client in the USDA approval of an ingredient for use in meat and poultry products
- Assisted clients in the preparation and implementation of internal compliance codes, including advertising and promotion policies and procedures
- Provided training sessions to clients, including management and sales force, in advertising and promotion issues
- Regularly counsel clients on labeling and advertising issues for dietary supplement and cosmetic products
- Advise Internet pharmacy clients on compliance with Federal and state laws and regulations
- Assisted a client in the filing of a Request for Hearing in response to FDA's Notice of an opportunity for a hearing on the agency's proposal to amend a DESI effectiveness finding
- Represented a client in successful litigation against FDA to enjoin the agency from regulating similarly situated parties differently
- Assisted a client with the marketing of a product as a legally appropriate medical food under FDA law and regulation
recognition
Member, FDLI Tobacco Committee
Advisory Board Member, Keyvive
news
Assisting in the planning of an FDLI tobacco conference in Spring 2011.
publications
Combating Teen Tobacco Use One Convenience Store at a Time: FDA Issues First Warning Letters to Tobacco Retailers, FDLI Update (May/June 2011) (co-authored with Will Woodlee).
Chapter 19: Sottera, Inc. v. FDA, in TOP 20 FOOD AND DRUG CASES, 2010 & CASES TO WATCH, 2011 (John Reiss ed. 2011) (co-authored with Will Woodlee)
"Tobacco Enforcement," presented at the FDLI Enforcement and Litigation Conference, Washington, DC (Oct 2010)
Marlboro Onserts: Another Colorful Addition to the Tobacco Regulatory Landscape, FDLI UPDATE (July/Aug. 2010) (co-authored with Will Woodlee).
"Too Many Cooks in the Kitchen? The Family Smoking Prevention and Tobacco Control Act's Impact on State and Local Authority," Update (Food and Drug Law Institute) November 2009.
"Prescription Drug Television Advertisement Advisory Review Fees - Not This Year," Regulatory Affairs Focus (Regulatory Affairs Professionals Society) (March 2008).
"The New Prescription Drug Television Advertisement Advisory Review Fees," Regulatory Affairs Focus (Regulatory Affairs Professionals Society) (December 2007).
"International Issues," presented at FDLI's Introduction to Medical Device Law and Regulation Workshop, Washington DC (November 2007).
"The New Drug Approval Requirement," presented at FDLI's Introduction to Drug Law and Regulation Workshop, Washington, DC (June 2004).
"Value-Added Program Review Committees - A Key Step Toward Effective Corporate Compliance" with Harvey O. Sussman, Update (Food and Drug Law Institute) (January 2003).
"After the Inspection: Addressing the 483 and the Establishment Inspection Report" with Alan H. Kaplan in How to Work with the FDA (2nd ed. Food and Drug Law Institute) (2002).
"Drink Yourself to Good Health and Inner Peace - Marketing Beverage-Type Products Containing Herbal Ingredients as Dietary Supplements," Update (Food and Drug Law Institute) (Nov 2001).
"Illegal Sampling Practices May Result in Huge Settlements" with Thomas O. Henteleff, Update (Pharmaceutical Distribution and Marketing Audits, Inc.) (Spring 2001).
"Expedited Approval" and "Orphan Exclusivity," presented at FDLI's Workshop, "The Changing Environment of Biologics." (June 2001)
"The Abbreviated NDA and Patent Exclusivity Issues," presented at FDLI's Workshop on Introduction to Drug Law and Regulation, Washington, DC (Feb 2001).
"Update of the Final Prescription Drug Marketing Act Regulations" with Thomas O. Henteleff, Update (Pharmaceutical Distribution and Marketing Audits, Inc.) (Winter 2001).
"FDA's Regulation of Over-the-Counter Drug/Dietary Supplement Combination Products," Update (Food and Drug Law Institute) (August 2000).
"After the Inspection: Addressing the 483 and the Establishment Inspection Report" with Alan H. Kaplan, How to Work with the FDA: Tips from the Experts (Food and Drug Law Institute) (2000).
"Relief for Tired Eyes: The US FDA's New OTC Drug Labelling Requirements," The Regulatory Affairs Journal (May 1999).
"Indications Variations in the United States," presented at "Successfully Filing Variations Under the New System in Europe," London, England (April 1997).
