FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products – FDA Watch
In the final part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s Regulatory Practice; Amy Van Gelder, Head of Skadden’s Chicago Litigation Practice; Brett Fleisher, M&A Partner at Skadden; and Katherine Armstrong, Deputy Director for the National Advertising Division of BBB National Programs. Together, they discuss how the regulatory approach to consumer products is evolving; how companies should respond to a broader and increasingly varied policy environment with multiple regulators; what’s happening at FDA with MoCRA implementation; litigation trends across the consumer products sector; how consumer products companies are navigating a more active plaintiffs’ bar; issues that are becoming more important in deal-making diligence and transaction structuring; significant risk or opportunity areas over the next year or so; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Rachel Turow
Rachel Turow leverages nearly two decades of experience in food and drug law to guide clients through a full range of FDA regulatory issues, with a focus on product development and regulatory strategy.
A former regulatory counsel at FDA, Ms. Turow also served as in-house counsel at multinational developers and sellers of highly regulated products. She utilizes her extensive experience in advising on corporate transactions and litigation, as well as on developing regulatory risk management strategies and defending against regulatory enforcement actions.
Prior to joining Skadden, Ms. Turow oversaw regulatory strategy and compliance in various in-house counsel roles for major pharmaceutical manufacturers. Her regulatory work spans new drug development, from preclinical through post-market, and she has direct experience gaining FDA approval and launching new products. She has also worked extensively on developing and securing FDA approval of generic drugs, 505(b)(2)s and biosimilars, and has in-depth knowledge of exclusivity and other complex regulatory issues unique to those product categories. Ms. Turow also has medical device regulatory experience, with a particular focus on drug-led combination and digital health products.
Most recently, she led the regulatory legal team at one of the world’s largest retailers. During this time, she directed a team of lawyers focused on a variety of regulatory issues related to consumer products, reduced legal risks across diverse product categories, developed policies and processes to safeguard business operations, handled regulatory inquires and enforcement actions and coordinated with the government affairs and litigation teams on high-priority FDA-related issues. In this capacity, Ms. Turow leveraged her knowledge of common regulatory issues that arise regarding over-the-counter drugs, dietary supplements, cosmetics and consumer medical devices.
At FDA, Ms. Turow developed and implemented guidance and regulations, responded to citizen petitions, and advised on issues relating to the approvals of drugs and biological products as part of the Center for Drug Evaluation and Research (CDER) and medical devices at the Center for Devices and Radiological Health (CDRH).
Amy Van Gelder
Amy Van Gelder is head of Skadden’s Chicago litigation practice. She represents companies, universities and directors and officers in complex commercial litigation, arbitration and trials, including securities, antitrust and consumer fraud class actions; bankruptcy litigation; shareholder derivative suits; and disputes arising out of mergers and acquisitions, commercial contracts, torts and alleged constitutional violations.
Ms. Van Gelder’s experience includes counseling clients in federal and state courts throughout the country and in all phases of litigation, including trial and appeal.
She also has represented corporations in regulatory investigations, including matters before the Department of Justice (DOJ), the Securities and Exchange Commission (SEC) and multiple state regulators.
In 2023, Ms. Van Gelder was recognized as one of Crain’s Chicago Business’ Notable Litigators and Trial Attorneys. She also repeatedly has been named one of Lawdragon’s 500 Leading Global Litigators and one of Crain’s Notable Women in Law (including in 2024) and previously was selected as one of its Notable Gen X Leaders in Law. Additionally, Ms. Van Gelder has been recognized in Best Lawyers in America in its Commercial Litigation category and in Lawdragon’s 500 Leading Litigators in America.
Brett Fleisher
Brett Fleisher advises public and private companies, financial sponsors and portfolio companies, family offices and hedge funds on U.S. and cross-border acquisitions, divestitures, mergers, carve-outs, financings, joint ventures, strategic investments, corporate governance and securities laws matters. She also represents CEOs and management teams in connection with private equity transactions.
In recognition of her work, Ms. Fleisher has been named one of Lawdragon’s 500 Leading Dealmakers in America and honored as a Rising Star by both Law360 and New York Law Journal.
Ms. Fleisher is actively involved in Skadden’s recruiting and corporate training programs. She is a co-chair of the firm’s Summer Associate Committee in New York and is a member of the Hiring Committee.
Katherine Armstrong
Katherine Armstrong is a deputy director for BBB National Programs’ National Advertising Division (NAD), a program established in 1971 to provide independent self-regulation for the U.S. advertising industry through a combination of independent monitoring and competitor challenges.
Katherine has more than 30 years of consumer protection experience from her tenure at the Federal Trade Commission (FTC), where she served in a variety of roles.
In her work as an FTC attorney advisor to Chairman Janet Steiger and Commissioner Sheila Anthony, she provided advice on all legal and policy issues related to consumer protection matters before the Commission.
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