A practical map of how product-promotion disputes can move beyond FDA alone.
The discussion widens product-promotion risk beyond the FDA and shows how a false or misleading claim can become a competitor, trademark, and litigation problem.
AGG Talks: Government Insight for Life Sciences Leaders Podcast Series
Arnall Golden Gregory LLP
13 episodes listed below
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In their own words
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.
As heard by us
Based on 4 episodes we listened to · September 2026
It traces federal health policy from agency decisions to concrete compliance risks across the life-sciences industry.
AGG Talks turns federal health enforcement into practical questions for life-sciences companies. Alan Minsk leads focused conversations with colleagues whose government experience informs their reading of agency action, repeatedly asking how regulatory changes reach corporate…
Why you'd press play
The OIG's issue du jour gets Alan Minsk's question: who decided it mattered to you?
Press play if you want
- a former OIG attorney's account of how advisory opinions draw an agency's attention
- options when a competitor's drug ad seems to get away with more than yours
Talks about
Best episodes of AGG Talks: Government Insight for Life Sciences Leaders Podcast Series
Short reviews from the PlayNext desk, based on the episodes we processed.
A measured look at patient assistance programs, reimbursement, and False Claims Act risk.
Patient assistance programs are treated as a live compliance issue where access, reimbursement, and False Claims Act risk intersect. Alan Minsk and David Blank keep the focus on recent developments, and Blank's former OIG perspective gives the discussion added weight when he…
A measured look at how DOJ enforcement pressure reaches across the life sciences supply chain.
AGG Talks frames the discussion around three enforcement issues affecting life sciences: the Consumer Protection Branch's recent restructuring, DOJ's crackdown on counterfeit drugs, and increased attention to gender-affirming care.
A dense regulatory discussion showing how policy shifts can ripple through healthcare operations.
This conversation frames Medicare policy as a business problem as much as a legal one. It moves from gender-affirming care and Medicare Conditions of Participation to the practical ways small regulatory changes can affect coverage, reimbursement, PBM formulary shifts, and…
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Episodes
- 1
Patient Assistance Programs and the False Claims Act: Enforcement Trends and Compliance Risks for Life Sciences Companies
Hidden gemPatient assistance programs are under the microscope here.
·23m·1 clip - 2
DOJ’s Shifting Enforcement: CPB Disbanding, Counterfeit Drug Focus, and Gender-Affirming Care Investigations
Hidden gemFormer DOJ attorney Gabe Scanapieco joins host Alan Minsk to analyze three major enforcement trends for life sciences companies: the surprising disbanding of the DOJ's Consumer Protection Branch and its implications, the ongoing crackdown on counterfeit drugs (especially pain meds and GLP-1s), and the emerging investigations into gender-affirming care.
·17m·1 clip - 3
How Medicare Regulations Could Affect Access to Gender-Affirming Care: Implications for Life Sciences Companies
Hidden gemThis episode examines how the federal government could use obscure Medicare Conditions of Participation (COPs) to restrict access to gender-affirming care, particularly for minors, despite Medicare being a program for seniors.
·17m·1 clip - 4
Tell Me Lies, Tell Me Sweet Little Lies: FDA Is Not My Only Potential Headache When It Comes to Product Promotion
Hidden gemFDA is only one headache here.
·29m·2 clips - 5
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Alan Minsk interviews former HHS General Counsel Brian Stimson about three critical legal developments for life sciences leaders: the process for HHS policy changes, the Supreme Court's recent ruling limiting nationwide injunctions, and the implications of the new DOJ-HHS False Claims Act Working Group.
·13m·1 clip - 6
Business Divorces in the Food and Supplements Space
Hidden gemBob Durkin says supplement-supply documents "don't matter until they do," and FDA would take a dim view of backdating agreements.
Sep 27, 2021·23m·1 clip - 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
Jun 29, 2021·13m - 8
Data Privacy Issues Life Sciences Companies May Encounter
AGG Talks examines data privacy issues affecting life sciences companies under Virginia, California, GDPR, and HIPAA frameworks.
Mar 1, 2021·20m·1 clip - 9
FDA Regulation of Rx Drug and Medical Device Advertising and Promotion: 2020 Year in Review
Feb 1, 2021·21m - 10
FDA Regulated Natural Products: Leveraging IP and Regulatory Requirements to Maximize Possible Return on Investment
Jan 1, 2021·40m - 11
Pandemic Marketing 101: Do’s and Don’ts to Market Your Brands, Products, and Services Safely
Attorneys Anuj Desai and Carolina Wirth of AGG explain that FDA treats Facebook posts and website copy as 'labeling,' so a hand sanitizer with a compliant box label still drew scrutiny for its online claims.
Dec 1, 2020·29m·2 clips - 12
Key Due Diligence Issues to Consider When Acquiring or Investing in Life Sciences Companies or Products
Nov 1, 2020·25m - 13
Quality Agreements for FDA-Regulated Products: Looking Under the Hood
Oct 1, 2020·27m