Antimicrobials Working Group
Improve the regulatory, investment, and commercial environment for antimicrobial drug and diagnostic device development to provide doctors and patients with innovative infectious disease treatment options.
AWG advocates for legislative and regulatory policies that support the development of new infectious disease treatments and diagnostics.
AMR is an urgent public health threat, exacerbated by R&D in the U.S. largely shifting away from investment in new antimicrobials, creating a serious unmet medical need.
Greater flexibility in regulatory approval requirements is needed to incentivize investment in novel antimicrobial and diagnostic device development. Policy options that strike an appropriate balance between safety, efficacy, and urgent needs in public health should be explored by industry together with the FDA and other key stakeholders.
Alternative pricing models must be explored to help improve the economic conditions surrounding antimicrobial and diagnostic device development and generate a robust antimicrobials pipeline.
AWG is also eager to work with subject matter experts, community members, advocates, and organizations that seek to support and expedite the development of antimicrobial drugs and diagnostic devices.