Overview
Jennifer Davidson is a partner who joined the firm in 1999. Focusing her practice on representing clients of all sizes, Jennifer excels at finding the most efficient ways to navigate the intricate regulations set in place by the FDA, the FTC, and related State and Federal agencies. Her clients in the pharmaceutical, dietary supplement, medical device, and cosmetic industries turn to her to help them to create and execute a comprehensive plan to ensure their companies stay in compliance with a variety of legal and regulatory requirements.
Jennifer has counseled pharmaceutical clients on a wide variety of matters related to life-cycle management, exclusivity questions, promotional and marketing practices, other post-approval requirements, user fees, and issues arising under the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, as well as those introduced by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and the Food and Drug Administration Amendments Act of 2007. She also spends a great deal of time assisting clients in presenting complex issues to the FDA via the agency’s Citizen Petition procedures as well as representing industries in registration and scheduling proceedings before the Drug Enforcement Administration (DEA).
Jennifer also ensures her clients are counseled on all aspects of promoting and marketing dietary supplements, OTC drug products, cosmetics, and medical devices, including product labeling. In addition to this, Jennifer has a deep understanding of the rules and regulations surrounding dietary supplements and she frequently advises them on the requirements of the Dietary Supplement Health and Education Act of 1994 and FDA’s implementing regulations, including product labeling, determining whether a product satisfies the definition of a dietary supplement, evaluating whether a new dietary ingredient notification is required, and identifying the types of claims that may be made in labeling and advertising.
Clients also know they can count on Jennifer to represent and advise them on a range of issues related to the development of advertising and labeling claims, including the adequacy of substantiation, the express and implied claims conveyed by promotional messages, and the evaluation of consumer perception surveys. She has worked closely with her clients in defending and initiating challenges against competitors’ labeling and marketing practices before the FDA, and before the National Advertising Division of the Council of Better Business Bureaus, Inc., and related entities, such as the Electronic Retailing Self-Regulation Program. Jennifer has also assisted clients in obtaining appropriate network clearance to air advertising on television as well as conducting civil litigation against the FDA on behalf of regulated industries.
Prior to joining Kleinfeld, Kaplan and Becker, Jennifer practiced in the Washington D.C. office of a large, international law firm, specializing in civil litigation.
Experience
- Represented dietary supplement client in advertising challenge before the National Advertising Division (NAD) of the Council of Better Business Bureaus and the National Advertising Review Board (NARB)
- Prepared Citizen Petition requesting imposition of standards on ANDAs and 505(b)(2) applications to ensure products are not less safe or effective than our client’s pioneer product
- Regularly assisted clients in the successful development and implementation of life cycle management strategies for innovative pharmaceutical products
- Represented a party opposing the grant of an importer registration by DEA in proceedings before the DEA Administrative Law Judge
- Submitted trade complaint requesting that FDA initiate enforcement activity against illegally marketed OTC products
- Assisted client in developing robust physician survey to support advertising claims
- Prepared Citizen Petition requesting that FDA impose scientifically appropriate standards for the demonstration of bioequivalence for ANDAs citing our client’s pioneer product as the reference listed drug
- Represented food client in advertising challenge before the National Advertising Division (NAD) of the Council of Better Business Bureaus
- Prepared Citizen Petition seeking to assure that follow-on combination products are held to the same standards, and are as safe and effective as, the client’s pioneer product
- Performed regulatory due diligence to evaluate pharmaceutical, cosmetic, dietary supplement, and food companies, as well as individual products, for potential acquisition
- Prepared Citizen Petition requesting that FDA adopt, announce, and implement a consistent standard for the acceptable level of impurities in active pharmaceutical ingredients approved by FDA for use in drug products
- Regularly assist clients in preparing submissions to FDA
- Pursued formal dispute resolution addressing CDER Division decision concerning content of a Written Request, which resulted in issuance of a Written Request consistent with client request, thereby providing an opportunity for pediatric exclusivity
- Regularly counsel clients on labeling and advertising questions concerning dietary supplements, cosmetics, OTC drugs, and foods
- Successfully argued the legal basis for eliminating evidentiary hearings on a client’s application to DEA for registration to import narcotic raw materials, despite such hearings having previously been routinely requested by competitors and granted by DEA – resulting in lower costs and a quicker registration for our client
- Prepared Citizen Petition seeking to ensure that all OTC switch applications for drug products within the same pharmacological class are subject to the same regulatory standards
- Regularly evaluated proposed advertising claims for pharmaceutical, dietary supplement, cosmetic, and food clients
- Pursued administrative appeal of denial of Freedom of Information Act request on behalf of pharmaceutical client
- Represented dietary supplement client in advertising inquiry from the National Advertising Review Council’s Electronic Retailing Self-Regulation Program (ERSP)
- Prepared Citizen Petition seeking to ensure 505(b)(2) applicant references appropriate listed drug and provides required patent certification
- Regularly advised pharmaceutical clients on pediatric exclusivity issues
- Prepared Citizen Petition requesting that FDA require NDAs and ANDAs to include particular in vitro data to assess potential alcohol-drug interactions
- Prepared comments on DEA proposal to reschedule a substance
- Submitted trade complaints requesting that DDMAC take action to halt improper promotion of competing prescription drug
- Prepared Petition for Stay of Action requesting that FDA require generic applicants to engage in risk management activities consistent with requirements imposed on innovator
- Counseled pharmaceutical clients on section viii “carve out” issues
- Initiated advertising challenge before the National Advertising Division (NAD) of the Council of Better Business Bureaus on behalf of food client
- Prepared comments in opposition to a Citizen Petition requesting that FDA require pharmaceutical client to make changes to its product label
- Prepared request for refund of user fees under PDUFA
- Prepared responses to state agency questions and observations following inspections of dietary supplement client
- Represented a party challenging the scheduling of a substance by DEA in proceedings before the DEA Administrative Law Judge
Publications & Speaking Engagements
Select Publications
- “FDA Amends the Definition of “Biological Product” and Prepares for the Conclusion of a Decade-Long Transition Period,” Co-Author, KKB Insights, February 2020
- “U.S. FDA and the Products it Regulates,” Co-Author, Kirk-Othmer Encyclopedia (2019).
Select Speaking Engagements
- “The New Drug Approval Process: Basic Concepts,” Speaker, FDLI’s Introduction to U.S. Drug Law and Regulation, Washington D.C., April 26-27, 2017
Recognition & Professional Activities
Best Lawyers in America, FDA Law, 2015-Present
News
Practice Areas
Education
B.A., University of Michigan (with high distinction)
Admissions
Maryland
U.S. District Court for the District of Maryland and the District of Columbia
U.S. Court of Appeals for the D.C. Circuit, Federal Circuit, and Eighth Circuit
U.S. Court of Federal Claims