Formulating an Ethics Agenda for Drug Development, Regulation, and Utilization

Area of Science:

• Bioethics
• Pharmaceutical Science
• Medical Device Regulation

Background:

• The pharmaceutical and device industry has historically neglected ethical dimensions in development and policy.
• This oversight has negatively impacted stakeholders, particularly patients.
• The industry's public standing has suffered due to perceptions of self-interest.

Purpose of the Study:

• To advocate for a broader examination of ethical considerations in the pharmaceutical and device enterprise.
• To introduce a framework for guiding ethical discussions in drug and device development.
• To propose a research agenda focused on the ethical aspects of pharmaceutical and device policy.

Main Methods:

• The editorial introduces ethical analysis principles.
• It proposes a framework for ethical discussions.
• It outlines a potential research agenda for ethical aspects.

Main Results:

• The inaugural edition of Therapeutic Innovation & Regulatory Science (TIRS) provides an introduction to ethical analysis.
• A framework is presented to guide ethical discussions.
• A research agenda is proposed for ethical aspects of drug, device, and companion diagnostics development.

Conclusions:

• There is a critical need to integrate ethical analysis into pharmaceutical and device development and policy.
• Therapeutic Innovation & Regulatory Science (TIRS) is positioned as a forum for this crucial discussion.
• Stakeholder involvement is invited to foster new thinking and improve industry practices for societal benefit.