When Pricing Pressure Reaches the FDA File: Practical FDA Realities

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In this second part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case, and Dan Troy, Managing Director at BRG. Together, they discuss where pricing pressures show up at FDA; how pricing issues affect how companies should think about evidence packages, differentiation claims, and life-cycle expansion; product features that often become flashpoints in pricing issues with FDA; lawful product differentiation versus differentiation that may later be portrayed as regulatory gaming; why CMC issues, manufacturing resilience, and shortage risk become more consequential amid pricing pressure; documentation surrounding regulatory and product-presentation decisions that could be second-guessed through a pricing lens; and much more.

This episode and the rest of our series do not include the usual Headlines and Resources Links segments.

About Our Guests

Bethany Hills

Bethany Hills is a regulatory partner whose practice integrates life sciences product regulation, healthcare compliance, corporate governance, enforcement risk management and cross-border transactional strategy. She advises global life sciences, healthcare and technology companies, investors and innovation platforms on complex regulatory challenges that span product development, commercial execution, enterprise compliance and enforcement readiness.

Bethany’s practice encompasses the full scope of U.S. regulatory frameworks affecting FDA-regulated products — including drugs, biologics, medical devices, diagnostics, digital health technologies, cosmetics, food and tobacco products — as well as the healthcare regulatory regimes governing reimbursement, provider operations, telemedicine, pharmacy regulation, laboratory oversight, DEA compliance and privacy. She combines deep subject-matter expertise with an operational understanding of how regulatory and compliance risk influences corporate strategy, capital deployment and global expansion.

One of the core components of Bethany’s practice is structuring and negotiating regulatory provisions in complex commercial arrangements across the life sciences supply chain. She advises on and drafts regulatory and quality frameworks embedded in manufacturing and supply agreements, CDMO arrangements, distribution and commercialization agreements, pharmacovigilance and safety data exchange agreements, quality and technical agreements, licensing and collaboration agreements, co-promotion and services agreements, and cross-border commercialization structures. Her work addresses regulatory responsibility allocation, GMP and quality system obligations, inspection risk, adverse event reporting, recall coordination, labeling control, promotional compliance, data governance and audit rights. She ensures that contractual frameworks align with FDA expectations and mitigate downstream enforcement exposure.

Bethany regularly supports sophisticated corporate initiatives, including public and private M&A transactions, cross-border investments, carve-outs, joint ventures and strategic alliances. She leads regulatory due diligence, structures risk allocation and compliance covenants, evaluates regulatory representations and warranties, and advises on post-closing integration of quality systems and compliance programs. Her regulatory assessments frequently inform valuation assumptions, indemnity architecture and closing conditions in high-stakes transactions.

She represents clients in government investigations, enforcement actions and high-stakes litigation matters involving FDA, DOJ, HHS-OIG, CMS and state authorities, including matters arising under the False Claims Act, FDCA, Anti-Kickback Statute, civil monetary penalty authorities, quality system regulations and promotional oversight rules. Her work frequently involves issues at the intersection of regulatory compliance and reimbursement, including government price reporting, drug pricing and market access strategy, Medicare and Medicaid coverage and payment integrity, value-based arrangements, and commercial and government reimbursement risk. She advises on enforcement exposure associated with pricing practices, reimbursement submissions, promotional claims, patient support programs and contracting structures. Her healthcare compliance counseling includes the design and operationalization of enterprise compliance programs, pricing and reimbursement controls, internal investigations, board reporting frameworks and remediation strategies.

A distinctive element of Bethany’s practice is her leadership in artificial intelligence governance and regulatory strategy within life sciences and healthcare. She advises companies developing AI-enabled products as well as enterprises deploying AI tools in research, manufacturing, pharmacovigilance, commercial analytics and care delivery. Her work addresses regulatory classification, evidence generation strategies, algorithm governance, cybersecurity, data integrity, global AI regulatory developments and associated enforcement risk.

Bethany is a frequent speaker and author on FDA enforcement trends, healthcare fraud risk, AI governance and product regulatory strategy. Bethany serves on the Law360 Life Sciences Editorial Board, the Artificial Intelligence in Precision Oncology Editorial Board, and is a Board Director for Drugs for Neglected Diseases (DNDi) North America.  She mentors founders and innovators through service on both the Women’s Health and HealthTech Councils for Springboard Enterprises and the New York Biodefense Commercialization Fund. Her practice is defined by the integration of product regulation and healthcare compliance with corporate and commercial execution — enabling clients to innovate, transact and operate globally within complex regulatory environments.

Dan Troy

Dan Troy is a globally recognized healthcare lawyer and accomplished executive whose career has spanned leadership positions in the life sciences, legal, and regulatory sectors. His past experience includes working as chief counsel for the US Food and Drug Administration (FDA), general counsel at multinational life sciences and technology companies, and partner at preeminent law firms.

Previously, Mr. Troy worked as a global general counsel at a multinational pharmaceutical and biotechnology company for ten years. He employed hands-on and practical approaches to creatively resolve major issues, manage risks, and achieve critical strategic goals. He led and managed a global team of over 630 professionals, including more than 400 attorneys, across more than fifty countries.

Mr. Troy is a highly sought thought leader, having served as chief counsel of the FDA, chaired the US Chamber Litigation Center, and led influential committees and sections within organizations such as the American Bar Association and the American Law Institute. He was named a “Legend in the Law” at the 2013 Burton Awards and selected in the Financial Times (FT) Global General Counsel 30 in 2016.

Mr. Troy is a seasoned executive and respected board member with extensive expertise in corporate governance, dispute resolution, and regulatory compliance. He is known for innovative litigation resolution and a cutting-edge approach to advising businesses. He combines exceptional technical legal skills honed over more than thirty years in private and governmental sectors with sound business judgment to drive success in complex and high-profile environments.