Title II – Preparing for the Future
DSCSA requires the development of an electronic, interoperable system to identify and trace certain drugs as they move through the US supply chain, which will ensure product traceability down to the unit level. Speakers will discuss updates on FDA’s pilot projects in this area, as well as what can be done now to prepare for interoperability and the implications it will have on recalls and suspect products. Lessons learned from the November deadline and preparing for deadlines through 2023 will also be discussed.
Elizabeth A. Gallenagh, Senior Vice President, Government Affairs and General Counsel, Healthcare Distribution Management Association
Mark Hendrickson, Senior Director, Sciences & Regulatory Affairs, Association for Accessible Medicines
Eric Marshall, Senior Director, Leavitt Partners, LLC
Dave Mason, AD Serialization ESO/Supply Chain, Sandoz, Inc.
2:00 – 2:15 PM
Coffee and Networking Break
2:15 – 3:15 PM
Concurrent Breakout Sessions
Title I – Update on Recent FDA Actions and Guidance Documents
Over the past year, FDA has released a slew of guidance documents and policy statements relating to compounded products. During this session, speakers will delve into the impacts of these actions, including the revised MOU with states, USP’s labeling materials, and recent discussions on adverse event reporting.
Matt Martin, Clinical Compounding Pharmacist, PCCA
Rachael Pontikes, Partner, Reed Smith LLP
Lee Rosebush, Chairman, Outsourcing Facilities Association; Partner, BakerHostetler; and Chair, Drug Quality and Security Act Conference
Sara Rothman, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, CDER, FDA
Title II – FDA Exemptions and Waiver Process
In May, FDA released a draft guidance document to help trading partners in the supply chain request waivers, exemptions, or exceptions from the DSCSA requirements. Speakers will discuss when to request a waiver, as well as address other considerations for this process including consideration of what constitutes a “product,” “transaction,” and “wholesale distribution.” FDA’s recent guidance on Verification systems will also be discussed.
Abraham Gitterman, Associate, Arnold & Porter LLP
Christine E. Kirk, Associate, Arnall Golden Gregory LLP
Moderated by Christina M. Markus, Deputy Chair, FDA & Life Sciences Practice, King & Spalding LLP
3:15 PM – 4:15 PM
Concurrent Breakout Sessions
Title I – Inspections and Enforcement in the Compounding World
FDA partnerships with states, DOJ actions, and warning letters – these are a few of the variety of enforcement and inspection activities happening within the compounding world. FDA and DOJ enforcement actions and consent decrees, product seizures, how to survive a shutdown, and predictions for the future will be discussed.
John W.M. Claud, Trial Attorney, US Department of Justice (DOJ)
Patrick C. Gallagher, Partner, Duane Morris LLP
Colleen M. Heisey, Partner, Jones Day
Title II – Inspections and Enforcement
Under the new track-and-trace rules, manufacturers, distributors, and dispensers must set forth the process for reporting and investigating suspect and illegitimate products, and methods for notifications for these products. Speakers will provide an update on this and other areas where FDA has been actively enforcing, as well as how requirements in other countries can impact imported products.
Todd Halpern, Partner, Venable LLP
John Murphy, Deputy General Counsel, Biotechnology Innovation Organization (BIO)
Moderated by James R. Johnson, Partner, Hogan Lovells US LLP