Issues Management

The Issues Management Team provides clients with critical support for their business, regulatory, and public policy strategies through the development of a compelling public health rationale. These efforts rely on a comprehensive analysis of the issues raised by the interaction of science, business, public health, and public policy. Each public health rationale may then be adapted for use among a broad range of audiences, including scientific, medical, policy, and regulatory experts; health care providers; advocacy organizations; and consumers. Our Issues Management Team takes an integrated approach while working closely with our other teams to assess and influence the scientific and policy environment for pharmaceuticals, biologics, and consumer healthcare products, both pre-and post-FDA approval.

The Issues Management Team:

Identifies and evaluates issues raised by a business, regulatory, or public policy action through the analysis and synthesis of scientific literature, regulatory documents, and other publicly available sources of information
Develops compelling and considered science-based, data-driven responses and positions on these issues, as well as strategies to manage their dissemination and acceptance among key stakeholders
Builds the public health rationale, including risk/benefit and pharmacoeconomic analyses, for both individual and entire classes of pharmaceutical, biologic, and consumer healthcare products
Engages key opinion leaders for expert analysis and consensus building, including the convening of expert advisory panel meetings
Develops peer-reviewed publications and other detailed reports based on scientific and public health assessments