FDA Watch

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.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

In this first part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case's New York office; Rahul Rao, Partner in White & Case's Washington, D.C., office; and John Barkett, Managing Director in BRG's Healthcare Transactions and Strategy practice. Together, they discuss FDA and product-strategy decisions that actually determine future pricing power developments; how certain factors shape market structure in ways that could attract anti-trust scrutiny; the line between lawful regulatory strategy and conduct that regulators or plaintiffs may characterize as competition-distorting; how management teams should think about government policy and product strategy differently amid intense price pressure; recurring fact patterns where companies unintentionally create anti-trust or stroke-of-the-pen risk; how recent political efforts around drug pricing may be tied to regulatory strategies from manufacturers; how competition authorities and deal-makers now assess FDA-derived barriers to entry in pharma and biotech; "pricing power risk" at the development stage; developments in DTC advertising; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. 

Music by Dvir Silver from Pixabay.

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.
To subscribe or find out more information about our podcast, visit FDAWatch.net.
Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.
Music by Dvir Silver from Pixabay.

Wayne chats with Dr. Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA. Together, they discuss FDA's proposed fiscal year 2027 budget, examine how it compares with past agency budgets, break down allocations and funding for multiple areas, look at Congress' role in budget review and approval, and much more.
Learn more about the Alliance for a Stronger FDA at www.strengthenfda.org. 

This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Wayne chats with Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug Practice at Wiley Rein. You'll hear their thoughts on the recent leadership changes at FDA; unanswered questions for the cosmetics industry as they move into long-term compliance with FDA's MoCRA requirements; the agency's draft guidance on its mandatory recall authority for cosmetics; how companies should be thinking risk management amid an influx of state regulatory movement; challenges balancing science, enforcement, and industry feasibility in cosmetics; the need for greater compliance and legal functions at cosmetics companies; where cosmetics and MoCRA could be headed next; and much more.
In our headlines segment, Wayne highlights these major developments:
FDA announces major expansion of internal AI capabilities, including rollout of "Elsa 4.0"
Pharma: FDA seeks input on new efforts to expand drug repurposing
Devices: FDA adds neurosurgical patties to medical device shortage list, warns supply disruptions could impact patient care
Food: FDA launches "Know Your Nutrition" campaign during National Women's Health Week
Cosmetics: PCPC joins coalition filing complaint challenging California's SB 343

In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. 

Music by Dvir Silver from Pixabay.