J&J hands over compassionate use reviews to academics
pharmafile | May 7, 2015 | News story | Sales and Marketing | J&J, JJ, academics, compac, eap, johnson
Johnson & Johnson has struck a ‘first-of-its-kind partnership’ with academic researchers to review requests for compassionate use of its investigational medicines.
The new panel will assess applications for a treatment produced by the company’s pharma arm Janssen – but if successful the committee will be deployed across Johnson & Johnson’s pharma products.
The partnership with academics at the division of medical ethics at the NYU School of Medicine will evaluate requests for investigational medicines, which are still in development and so usually in limited supply – and yet to be approved by the FDA or other health regulators.
The Compassionate-Use Advisory Committee (CompAC), an external group of 10 independent medical experts, bioethicists and patient representatives, will make recommendations on applications for individual patient requests made by doctors from anywhere in the world. The committee’s recommendations will inform Janssen clinicians, who will make the final decision.
Along with other companies Janssen can establish an Expanded Access Programme (EAP) for patients to receive investigational medicines that have a clear route to market already established with regulators, and a favourable risk profile. If patients do not qualify for an EAP or an existing clinical trial, their requests will be forwarded to the CompAC.
The FDA defines compassionate use as “a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions [that] have not yet been approved by the FDA and they have not been proven to be safe and effective.”
In practice, companies often consider compassionate use as a medical request for access for a single patient outside of other company-sponsored programmes, like clinical trials or an EAP.
“This initiative demonstrates the commitment of Johnson & Johnson to the highest ethical standards and patient-centred decisions,” says the company’s chief medical officer Joanne Waldstreicher. “We believe that an external group of ethicists, physicians and patient representatives brings the highest level of both medical and ethical input to our decision-making process.”
CompAC chairman Art Caplan, a professor of bioethics and director of the division of medical ethics at the NYU School of Medicine, says: “Our goal is to ensure that compassionate use is guided by ethical principles, and that the selection process continues to be thorough, transparent and fair.
“Compassionate use decisions are incredibly challenging, and we readily acknowledge that the current allocation system remains a work in progress. This new initiative hopes to create a more robust model to help guide these decisions. If successful, CompAC will serve as a model for others in industry and in government to follow.”
Lilian Anekwe
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