In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair of the firm&#x27;s Life Sciences industry team. Together, they discuss trends in FDA and DOJ enforcement in 2026; how FDA and DOJ have approached the oversight of GLP-1 drugs; DOJ&#x27;s non-prosecution agreement resolutions with Alibaba and AUS Merchant Services and what they mean for FDA enforcement; other products drawing attention from FDA and DOJ; recent FDA enforcement actions; what companies should do now and what should they watch for in the second half of the year related to enforcement; 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.

FDA Legal, Regulatory &amp; Compliance Issues, Part 1: FDA &amp; DOJ Enforcement

FDA Watch

If somehow you are an entity that makes money and helps put these products into commerce, you need to be familiar with what the FDA regulates, how they regulate it, and the trends of what they're looking at.

Hello, welcome to a very special episode of FDA Watch. I'm your host, Wayne Pines. As you know, we're the leading independent podcast on FDA. And we continue to grow episode by episode, very pleased with the listenership that we've had.

I'm very excited about this episode. It's the first installment in one of our signature multi-episode series that we produce in collaboration with law firms and other organizations. Today's episode is the first we're doing jointly with one of the best known food and drug law firms, Arnold Golden Gregory.

The four part series will focus on several issues. Today we're going to be discussing the current state of enforcement by FDA and the Department of Justice, DOJ. Unfortunately, we have just the right person to lead us on that journey, Gabe Skana-Pieko. Dave is a partner at Arnold Golden Gregory, co-chair of the firm's life sciences industry team.

He focuses on litigation, compliance, investigations. He's a former assistant director in the GOJ consumer protection branch. He advises clients on enforcement risks, internal investigations, and other disputes involving FDA regulated products. So, Gabe, it's good to see you and to meet you. Thanks for having me, Ian.

So, let's begin with an overview question. What's the big picture? What are the headline stories in 2026 in terms of trends in DOJ enforcement involving FDA products?

FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement

Read the full transcript

The candid version is on a podcast,
not the earnings call.

FDA Legal, Regulatory &amp; Compliance Issues, Part 1: FDA &amp; DOJ Enforcement

Read the full transcript

The candid version is on a podcast, not the earnings call.

FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement

The candid version is on a podcast,
not the earnings call.