Jennifer Davidson is a partner who joined the firm in 1999. She represents large, small, and start-up companies on a wide range of FDA-related matters. She has counseled members of the pharmaceutical, dietary supplement, cosmetic, food, and medical device industries on a variety of legal and regulatory matters involving the FDA and related State and Federal agencies.

In recent years, Ms. Davidson has advised pharmaceutical clients on promotional and marketing practices, other post-approval requirements, life-cycle management, exclusivity questions, 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. A significant component of her practice involves assisting clients in presenting complex issues to FDA via the agency’s Citizen Petition procedures. Ms. Davidson also has experience representing industry in registration and scheduling proceedings before the Drug Enforcement Administration.

Her practice also includes counseling companies on all aspects of promoting and marketing OTC drug products, medical devices, foods, and cosmetics, including product labeling. With respect to dietary supplements, Ms. Davidson has advised clients on the requirements of the Dietary Supplement Health and Education Act of 1994, including product labeling, determining whether a product satisfies the definition of 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.

Ms. Davidson also advises companies on a range of related issues associated with 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 assisted clients in defending and initiating challenges against competitors’ labeling and marketing practices before the FDA and in related private disputes under the Lanham Act and before the National Advertising Division of the Council of Better Business Bureaus, Inc., and related entities, such as the Children’s Advertising Review Unit and the Electronic Retailing Self-Regulation Program. Ms. Davidson also assists clients in obtaining appropriate network clearance to air advertising on television. Her practice also involves civil litigation against the FDA on behalf of regulated industry.

Before joining Kleinfeld, Kaplan and Becker LLP, Ms. Davidson practiced in the Washington D.C. office of a large, international law firm, specializing in civil litigation.

  • Represented dietary supplement client in advertising challenge before the National Advertising Division (NAD) of the Council of Better Business Bureaus
  • 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
  • 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
  • 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
  • Regularly assisted clients in the successful development and implementation of life cycle management strategies for innovative pharmaceutical products
  • 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
  • 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 advised clients on proper labeling of dietary supplements, cosmetics, OTC drugs, and foods
  • Assisted client in developing robust physician survey to support advertising claims
  • 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 complaint 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
  • Evaluated taste tests in support of advertising claims
  • Represented a party challenging the scheduling of a substance by DEA in proceedings before the DEA Administrative Law Judge

Best Lawyers in America (FDA Law) 2015-2019