Matt Newcomer Presents on Off-Label Marketing at the American Society of Pharmacy Law's Developments in Pharmacy Law Seminar on Nov. 13
November 9, 2016
On Sunday, November 13th, Internal Investigations & White Collar Defense Principal Matthew T. Newcomer co-presented with Tami Millner, Associate Director, Regulatory Affairs, Shire, and Soumi Saha, Assistant Director of Pharmacy & Regulatory Affairs, Academy of Managed Care Pharmacy (AMCP), at the American Society of Pharmacy Law's (ASPL) Developments in Pharmacy Law Seminar in Austin, TX.
The presentation addressed the quickly-shifting status of the laws and regulations that restrict proactive promotion of off-label information, including clinical and economic information. Recent federal court decisions, such as Amarin Corporation, Pacira Pharmaceuticals, and Vascular Solutions, among others, challenge the current legal restrictions by holding that off-label communications are protected under the First Amendment as long as they are truthful and not misleading. As a result, Congress has questioned the Food and Drug Administration’s (FDA) regulatory authority in this area and urged the FDA to publicly clarify its position on off-label communications given that they are constitutionally permissible. The presenters discussed the implications for biopharmaceutical manufacturers and pharmacists if restrictions on off-label communications are lifted.
ASPL is a nonprofit professional association for individuals with an interest in legal issues as they pertain to pharmacies, pharmaceuticals, and related products and services. The ASPL annual seminar brings together over 250 industry professionals to share the most up-to-date, relevant, and practical information. Click here for more information >