Johnson & Johnson, responding to an unsettled ethical, medical and PR issue, has tapped a prominent bioethicist to lead a third-party advisory committee to decide access for seriously ill patients to drugs that haven't yet been approved.
The Food and Drug Administration allows "compassionate" access to so-called investigational (unapproved) drugs and simplified the process earlier this year after sustained criticism – fueled by social media and viral news reports – by terminally ill patients trying to obtain experimental drugs.
J&J said May 7 it has created a third-party pilot program with the Division of Medical Ethics at the NYU School of Medicine to decide applications for such access, led by renowned bioethicist Arthur Caplan. The program, Compassionate-Use Advisory Committee, or CompACT, is initially centered on a single J&J drug in its Janssen unit but will be expanded companywide if successful, J&J said.
"Our goal is to ensure that compassionate use of specific investigational medicines still in development is guided by ethical principles, and that the selection process continues to be thorough, transparent and fair," said Caplan.
Compassionate access to drugs carries risks to drug companies in multiple areas, including to possibility of harm to the patient, the limited availability and often high demand of experimental drugs, and the difficult task of deciding which desperate patients will get doses or treatment.
As inVentiv Health PR's Meg Alexander wrote in O'Dwyer's last month, the parents of a young boy suffering from cancer successfully leveraged a social media campaign to pressure drug maker Chimerex (and the FDA) to open clinical testing of an experimental drug. The #SaveJosh campaign, lauded by many as a PR success, raised concerns in the healthcare sector about pressure campaigns for access to unapproved drugs.
Lo Isidro, senior director at Real Chemistry with more than a decade of strategic communications and PA experience, has joined Narrative Strategies.
Nelson Fernandez, former North American chair of APCO Worldwide and managing director of Burson-Marsteller, has joined Volunteers in Medicine Berkshires as director of communications and PA.
Lilit Bargar, who was most recently an EVP in the healthcare practice at Weber Shandwick, comes on board at GCI Health as EVP, corporate practice lead.
Five ways that successful thought leaders are made.
Have a comment? Send it to 
No comments have been submitted for this story yet.