On Monday, Ariana Eunjung Cha wrote about the difficult ethical issue of Compassionate Use, which allows a patient access to an unapproved treatment when others with similar requests are denied access.
Arthur Caplan, director of the division of medical ethics at New York University’s Langone Medical Center, describes it as a moral dilemma that could not be ‘more troubling and impossible-to-resolve’.
In the article, Caplan asserts that ‘it’s best for the company to focus on getting the drug approved as soon as possible so that the largest number of people can be helped, but from a patient’s point of view, getting immediate access to the drug is what’s important… It’s a trade-off between the public good versus self-interest’.
The Food and Drug Administration has rules for expanded access or compassionate use, but Eunjung Cha points out that the program remains limited. Since 2009, the agency has approved an average of 1,030 applications each year; each request may be for multiple patients, but most patients’ requests never make it to that stage as companies must agree to allow their drug to be used before the FDA gets involved.
BIO’s statement on compassionate use can be accessed here.