Insight Session
Reshaping Care Access: FDA’s Nonprescription Drugs with Additional Conditions for Nonprescription Use
Last year, FDA finalized the regulatory pathway for a new category of over-the-counter drugs that will be approved with “additional conditions for nonprescription use” (ACNU). This product category is expected to initially include treatments for minor, self-limited conditions and once available, these products have the potential to fundamentally change how Americans access care. This session will explore how the coming availability of these products could reshape how Americans access care and potentially the types of related clinical care services offered by pharmacists.
Thomas M. Menino Convention & Exhibition Center, Room 257
Ilisa Bernstein
President
Bernstein Rx Solutions, LLC
Ilisa Bernstein, PharmD, JD, FAPhA, is President of Bernstein Rx Solutions, LLC, where she advises life sciences organizations on complex FDA and pharmacy regulatory issues. A nationally recognized leader in drug regulation and compliance, she brings more than 35 years of experience spanning government, nonprofit, and private sectors.
Charley John
Vice President, Public Policy
UnitedHealth Group
Charley John is a healthcare policy and operations leader with nearly 30 years of experience improving healthcare access, affordability, and outcomes. As Vice President of Public Policy at UnitedHealth Group, he works at the intersection of healthcare delivery, public policy, and innovation, advancing strategies that strengthen care quality, enhance consumer experience, and support sustainable healthcare programs.
Samantha Picking, PharmD
Senior Director, Immunizations
Walgreen Co.
Samantha Picking, PharmD, is Senior Director of Immunizations, responsible for developing and implementing enterprise-wide immunization strategies by working closely with cross-functional teams, including marketing, digital/IT, pharma, clinical, regulatory and operations. These teams help design, build, and deploy new and enhanced immunization program offerings to drive equitable and convenient access to life-saving vaccines.
David Spangler
Senior Vice President, Legal, Government Affairs & Policy
Consumer Healthcare Products Association
David Spangler leads the Consumer Healthcare Products Association’s legal, government affairs, and policy team. He has particular expertise in regulatory matters. Spangler joined CHPA in 1984 as a legislative analyst. He subsequently served in a number of roles for the association in the president's office, project management, international affairs, and, after completing law school in 1995, the association's legal department. Spangler was named a vice president in 1997, and a senior vice president in 2006. His responsibilities were expanded to his current role in 2019.