Johnson & Johnson announced Thursday a first-of-its-kind partnership that will enlist a third-party review of requests for compassionate use of investigational medicines being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
Janssen Research & Development, LLC will be teaming up with the NYU School of Medicine's Division of Medical Ethics to receive independent advice that will aid the evaluation of requests to use medicines still under investigation before they are approved by the U.S. Food and Drug Administration or other health authorities around the world. Doing so would ensure that decisions are made in the most ethical manner.
The Compassionate-Use Advisory Committee will be set up by the NYU School of Medicine, bringing together 10 patient representatives, medical experts and bioethicists to lead the new approach. The CompAC will be making recommendations about individual requests, and these recommendations will be used by Janssen clinicians to make their final decision.
"We have a responsibility to patients and their families to ensure their well-being in everything we do," said Amrit Ray, M.D., chief medical officer for the Janssen Pharmaceutical Companies of Johnson & Johnson.
Ray added that by ensuring an independent team of experts assess compassionate use requests, Janssen will be able to come up with the most responsible decisions possible, factoring in patient condition and pertinent risk factors.
Where allowed by local authorities, Janssen will also be establishing an Expanded Access Program (EAP), allowing treatments to be made available to individuals diagnosed with a serious condition for which the investigational medicines were originally intended. Should a patient not meet EAP requirements, their request will be investigated by the CompAC.
The committee will be headed by Art Caplan, Ph.D., Division of Medical Ethics director. According to him, compassionate use decisions pose a lot of challenges. The CompAC recognizes that current systems are still works in progress and hopes to pioneer a more robust model that will provide guidance for decisions. If the committee is successful, CompAC might even serve as the model other ethicists can follow.
Joanne Waldstreicher, M.D., chief medical officer for Johnson & Johnson, said that the initiative shows the company's commitment toward achieving the best possible ethical standards and making the most patient-centered decisions.
The FDA defines compassionate use as a means for patients to get access to biologics, drugs and medical devices still under investigation for serious conditions and diseases. Given they have not been approved by the agency yet, these investigational biologics, drugs and medical devices are not guaranteed to be safe and effective.
