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. 

In this episode, partner Kevin M. Bell and of counsel Bob 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.

In this episode, 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.

In this episode, Alan G. Minsk, partner and leader of the Food & Drug practice team, is joined by Brian A. Teras, partner of the Corporate & Securities practice team. They provide an overview of the diligence process, potential red flags, common mistakes, and other factors to consider during the due diligence process.

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 & Biologics industry team. 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.