Problem
The Director of a national non-profit patient organization has contacted you because she is considering filing a lawsuit against the FDA for refusing access to a promising new drug for the treatment of migraine headaches. She explains to you that over the last several years her organization has repeatedly requested the FDA to allow a group of ten patients to purchase and use a drug undergoing Phase I clinical trials. The FDA has denied all of these requests.
She describes the patients' symptoms as severe and persistent, often interfering with daily functioning in their professional capacities and at home with their families. In speaking with her, it becomes apparent to you that she has no knowledge of important case law addressing the topic of access to experimental drugs. When you try to discuss it with her, she asks you to provide this information in a digestible format for her and the Board members of the patient organization so she can share the information with the Board at the next meeting.