Baker McKenzie is pleased to launch the fifth in our Biden Supply Chain Policy video series focused on the pharmaceuticals and active pharmaceutical ingredients supply chain, which is another of the critical supply chains that has been a particular focus of the Biden Administration. The Biden Administration has been pursuing policies aimed at increasing resilience in this supply chain by addressing shortages and minimizing disruption through a range of measures, including efforts to on-shore and near-shore production to reduce reliance on foreign countries.
In this video Kerry Contini (Partner, Washington DC), Maurice Bellan (Partner, Washington DC), and Veleka Peeples-Dyer (Partner, Washington DC) discuss some of the key legal and compliance considerations for companies operating in this supply chain, with a specific focus on the impacts of the Biden Administration’s policies on FDA regulations and government procurement.
We invite your to watch the other short videos in these series: key trends (see here), the semiconductor supply chain (see here), the large-capacity batteries supply chain (see here) and the critical minerals and strategic materials supply chain (see here).
We hope that you find this discussion to be helpful and encourage you to reach out to us to discuss what the Biden Administration’s supply chain policies may specifically mean for your business.
Click here to watch Video 5: Biden Supply Chain Policy on Pharmaceuticals and Active Pharmaceutical Ingredients
Kerry B. Contini
Kerry Contini is a partner in the Firm's International Trade Practice Group in Washington, DC. Kerry focuses her practice on export controls, trade sanctions, and antiboycott laws. This includes advising US and multinational companies on trade compliance programs, risk assessments, licensing, review of proposed transactions, and enforcement matters. Ms. Contini works regularly with companies across a wide range of industries, including the pharmaceutical/medical device, oil and gas, and nuclear sectors.
Maurice A. Bellan is the Managing Partner of the Washington, DC office and a member of the Global Dispute Resolution and North America Litigation and Government Enforcement Steering Committees. He is a former trial attorney at the US Department of Justice and is experienced in a broad range of fraud and anti-corruption matters. Maurice was recently named by Savoy magazine as one of the most influential African-American lawyers in the United States.
Veleka R. Peeples-Dyer
Veleka Peeples-Dyer is Chair, North America FDA Practice Group for Baker McKenzie. Veleka brings more than 20 years of strategic and practical business and legal counsel to a wide span of biopharmaceutical companies, advising on FDA regulatory and compliance matters, including over 15 years of senior in-house counsel experience in leading biopharmaceutical companies. Veleka’s practice provides full coverage for clients, including, but not limited to, clinical trials and good clinical practices (GCP); current good manufacturing practices (cGMP), including quality systems and quality management programs; pharmacovigilance; advertising and promotion; licensing, development and collaboration agreements; and compounding and compliance and enforcement, including assistance with FDA 483 audits, responses to warning letters and assistance with corrective and preventative actions (CAPAs) and other FDA enforcement actions.