Bioethics Blogs

Pre-Approval Access: Can Compassion, Business, and Medicine Coexist?

Tomorrow and Thursday in New York City is an expert-rich conference on compassionate use.

Patients who have a serious or life threatening condition for which no satisfactory alternative therapy exists and who cannot enter a clinical trial may, under certain circumstances, gain access to new investigational medicines through what is known as “pre-approval access” or “compassionate use.” 

The prospective benefits of non-regulatory approved medicines may outweigh the potential risks for many critically ill patients. However, a number of ethical and safety concerns have been raised related to ensuring that unapproved treatments are equitably distributed via systematic approaches, that society as a whole is best served through scientific studies on the risks and benefits of new medicines, and that individual patients are protected from undue harm.

Speakers and moderators include Arthur Caplan, Nancy Dubler, legislators, industry leaders, federal agency regulators, and key advocates.

Here are the session titles:

  • Session I. Patients’ Perspectives: Compassionate Use and Expanded Access
  • Session II. Case Study: Josh Hardy and the Impact of Social Media
  • Session III. Compassionate Use during a Public Health Crisis: Lessons Learned from the Ebola Epidemic
  • Session IV. Stakeholder Perspectives: Key Issues When Considering a Compassionate Use Request
  • Session V. Can Legislative or Regulatory Changes Ameliorate the Challenges of Compassionate Use and Expanded Access?
  • Session VI. International Perspectives: How do Compassionate Use and Expanded Access Policies Differ Globally?
  • Session VII. New Directions for “Pre-Approval” Access
  • Session VIII. Future Vision: Ethics and Policy Lens

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.