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.

In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Gabe Scannapieco, Litigation and Healthcare partner and Life Sciences co-chair, unpack recent shifts 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.

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 formal 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 nationwide 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.

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.

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.

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.

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.

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.