FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals – FDA Watch
In this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s FDA Regulatory Practice; Raquel Fox, Head of Skadden’s U.S. ESG Practice and Co-Head of the firm’s SEC Reporting and Compliance Practice; Kendall Ickes, Associate in Skadden’s Intellectual Property and Technology Practice; and Tess Cameron, Managing Director on the Venture Team at RA Capital Management. Together, they discuss helping pharmaceutical and biotech industry clients navigate the uncertain regulatory environment; how FDA is expanding its scope of responsibility; staffing and policy changes at FDA and how they impact the review process; considerations from an SEC disclosure perspective for how companies talk about their product development; protections and assurances buyers may be looking for in the deal context; 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).
Raquel Fox
Raquel Fox is the head of Skadden’s U.S. ESG practice and co-head of the firm’s SEC Reporting and Compliance practice. She concentrates her practice in the areas of capital markets, mergers and acquisitions, corporate governance, and general corporate and securities matters, advising clients on the full range of ESG and SEC reporting and compliance requirements.
During Ms. Fox’s 10 years of service at the SEC, she held several leadership positions, including serving as the director of the Office of International Affairs, senior adviser to then-Chairman Jay Clayton and senior special counsel to two directors in the Division of Corporation Finance. She also served as a professional attorney fellow in the SEC’s Office of Rulemaking and Office of Capital Markets Trends.
While at the SEC, Ms. Fox oversaw the agency’s participation in international disclosure-related projects that focused on ESG, accounting and audits, emerging risks, data privacy and fintech; coordinated with the Sustainability Accounting Standards Board and the Task Force on Climate-related Financial Disclosures (two key ESG disclosure frameworks); and led negotiations with senior U.S. and foreign regulatory officials. She also managed enforcement and supervisory assistance programs to support cross-border securities examinations, investigations, trading suspensions and enforcement actions by the SEC and foreign authorities. Additionally, Ms. Fox served as a primary adviser on rulemakings, legal interpretations, the SEC’s disclosure review program, cybersecurity disclosure, shareholder proposals, corporate governance matters, capital formation and enforcement referrals. She also provided substantial assistance on the Disclosure Effectiveness Initiative to help modernize the public company reporting regime, including on the legal and accounting requirements of SEC filings and technological improvements to EDGAR. In recognition of her work, she was selected as the recipient of three SEC Law and Policy awards.
Ms. Fox has been ranked in Band 1 of Chambers USA and recognized as one of Lawdragon’s 500 Leading Lawyers in America and 500 Leading Dealmakers in America. She was selected as a 2022 fellow of the American College of Governance Counsel. She also is currently vice chair of the Nasdaq Listing and Hearing Review Council, which is responsible for making recommendations to the Nasdaq board on policy and rule changes related to issuer listing standards. She regularly appears on panels to provide her extensive insights on ESG developments, SEC reporting and compliance, and corporate governance matters.
Before joining the SEC, Ms. Fox was a counsel at an international law firm in its Washington, D.C. office, where she advised companies and their boards on securities law compliance and corporate governance matters and represented issuers and underwriters in capital markets transactions. She began her career as a certified public accountant.
Kendall Ickes
Kendall Ickes focuses her practice on transactional matters in the intellectual property and technology space.
Ms. Ickes advises clients from a wide range of industries, including financial services and private equity, with a strong focus on matters in the health care, pharmaceuticals and biotechnology sectors.
She also provides intellectual property and technology-related support on M&A and secured financing transactions.
Tess Cameron
Tess Cameron is a Managing Director on the Venture Team at RA Capital Management. Tess works on investments and serves on several company boards.
Previously, Tess held finance leadership roles at Foghorn Therapeutics, Wave Life Sciences, and Biogen. Prior to joining biotech/pharma, she was a specialist in the corporate finance team at McKinsey & Co, focused on corporate transactions. Tess holds a BA with a double major in Economics and Peace & Conflict studies from the University of Toronto, Canada.
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