AGG Talks: Government Insight for Life Sciences Leaders Podcast Series
Our podcast series hosts strategic conversations at the center of life sciences, law, and policy. During each episode, AGG’s former government attorneys bring firsthand knowledge and updates from their respective agencies — such as the HHS and DOJ — and examine how the latest regulatory developments and enforcement trends impact life sciences organizations. These insider insights, paired with the practical experience of AGG’s Life Sciences team, offer the life sciences industry a map of the road ahead in today’s regulatory environment.
Episode 3: How Medicare Regulations Could Affect Access to Gender-Affirming Care: Implications for Life Sciences Companies
In this episode, AGG Life Sciences co-chair Alan Minsk and Healthcare partner Andrew Tsui examine how the Centers for Medicare & Medicaid Services (“CMS”) may apply the Medicare Conditions of Participation (“COPs”) to emerging areas of healthcare, including gender-affirming care — and what those developments could mean for pharmaceutical companies and drug manufacturers.
They discuss how updates to COPs can impact operational requirements for healthcare providers and influence compliance considerations. Andrew also examines how these changes could ripple through payor markets, pharmaceutical coverage, and the broader regulatory framework affecting the life sciences industry.
With his experience as former litigation counsel at HHS’s Office of the General Counsel, CMS Division, Andrew shares strategies that life sciences leaders can implement to adapt to modern regulatory and compliance actions.
Episode 2: DOJ’s Shifting Enforcement: CPB Disbanding, Counterfeit Drug Focus, and Gender-Affirming Care Investigations
In this episode, AGG Life Sciences co-chairs Alan Minsk and Gabe Scannapieco unpack recent developments at the U.S. Department of Justice that could reshape regulatory risk for life sciences organizations.
They discuss the disbanding of DOJ’s Consumer Protection Branch (“CPB”) and what the loss of centralized oversight could mean for coordinated investigations in the industry. The conversation also examines DOJ’s intensified focus on counterfeit drugs and its targeting of the entire supply chain in collaboration with FDA, DEA, and other agencies.
Drawing on Gabe’s experience as a former assistant director at the CPB and the firm’s extensive regulatory services, this episode provides practical insights for companies looking to stay ahead of shifting enforcement priorities.
Episode 1: HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former Acting General Counsel and Principal Deputy General Counsel of the U.S. Department of Health and Human Services (“HHS”), discuss three recent developments affecting life sciences companies.
Alan and Brian review the HHS policy-making process, including the requirements for changing policies that have undergone notice-and-comment rulemaking. They also examine the Supreme Court’s decision in Trump v. CASA, which limits universal injunctions and places greater responsibility on companies to take direct action to protect their interests. Finally, they address the newly formed DOJ-HHS False Claims Act Working Group, highlighting its enforcement priorities — such as drug and device pricing and kickbacks — and potential implications for payment suspensions and case dismissals.
Archive
Episode 9: Tell Me Lies, Tell Me Sweet Little Lies: FDA Is Not My Only Potential Headache When It Comes to Product Promotion
In this episode, Alan G. Minsk, AGG Food & Drug team leader, and Anuj Desai, AGG Intellectual Property partner and head of Trademarks, discuss recent developments that remind our audience in the food and drug space that FDA is not the only regulatory agency that’s keeping an eye on the marketplace. Alan and Anuj look at how NAD, a BBB program that supports advertising self-regulation, recently addressed a challenge in the prescription drug space. They also talk about how FTC investigative priorities in the past several months may be relevant to the food and drug/life sciences space.
Episode 8: Business Divorces in the Food and Supplements Space
In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business divorces or disputes between companies in the food and supplements space. They will discuss, among other things, post-divorce product regulatory status and related business challenges, as well as strategies that can be employed at the beginning of the business relationship to help mitigate risk if the relationship goes bad.
Episode 7: Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply from an FDA and Corporate Perspective
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and Genevieve M. Razick, an attorney in our Healthcare and Food & Drug practices, along with Leah D. Braukman, an attorney in our Corporate & Finance practice, discuss the specifics of the small business user fee waiver, who qualifies, and how to apply from an FDA and corporate perspective.
Episode 6: Data Privacy Issues Life Sciences Companies May Encounter
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and co-chair of AGG’s Data Privacy practice, Kevin L. Coy, discuss U.S. and international privacy and data security law issues life sciences companies may encounter such as privacy policies, the patchwork of federal and state privacy and data security laws in the U.S., international data protection laws, such as GDPR, and related international data transfer issues.
Episode 5: FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: 2020 Year in Review
In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick, give an overview of FDA’s Office of Prescription Drug Promotion’s (OPDP) enforcement of unlawful advertising in 2020.
Episode 4: FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
AGG Dietary Supplements team leader Kevin M. Bell and team member Robert Durkin discuss some of the more interesting issues and challenges they have encountered when working with clients to ensure they maximized opportunities to monetize the greatest value from their natural products and how a well thought out and executed regulatory strategy can help.
Episode 3: Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely
AGG partner Anuj Desai and of counsel Carolina M. Wirth discuss the Federal Trade Commission (FTC) and Food and Drug Administration’s (FDA) roles of protecting consumers at the height of a public health crisis and the types of advertising and legal compliance issues that have surfaced in the past several months as well as provide a recap of agency actions.
Episode 2: Key Due Diligence Issues to Consider When Acquiring or Investing in Life Sciences Companies or Products
In our second episode, Alan Minsk and Brian A. Teras cover key due diligence issues to consider when acquiring or investing in life science companies or products. They provided an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process.
Episode 1: Quality Agreements for FDA-Regulated Products: Looking Under the Hood
In our inaugural episode, Alan G. Minsk, partner, and leader of the Food & Drug practice team is joined by Michael E. Burke, co-chair of the Pharmaceuticals & Biotechnology industry team, and the administrative partner of the firm’s D.C. office as they discuss issues around quality agreements for FDA regulated products as well as topics related to manufacturing, FDA timelines, and compliance with relevant national authorities.
Stay tuned for more from AGG’s Food & Drug team on this channel.
- Alan G. Minsk
Partner
- Brian R. Stimson
Partner
- Gabriel H. Scannapieco
Partner
- Andrew Tsui
Partner
- David M. Blank
Partner
