Johnson & Johnson has decided to bring in bioethicist Arthur L. Caplan of New York University to create a panel that will make decisions about lifesaving medicines that have not yet been approved. The panel creation will be announced Thursday, according to The New York Times.
It has been an ongoing debate whether or not those who are terminally ill should have access to unapproved drugs still in testing phase, even in times of desperate need. But with a company the size of Johnson & Johnson making this choice for the new development, it could potentially inspire other drug companies to do the same.
The Times explained what the new plan entails:
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Caplan, who has written extensively about the issue of experimental drug availability — known as “compassionate use” — would oversee an independent panel of doctors, ethicists and patient advocates that will review requests for access to a limited array of experimental medicines and decide how Johnson & Johnson should respond.
The pilot program will be funded by the company but the company will have no influence on the panel’s decisions, Johnson & Johnson said, adding that payments will go directly to the university. Dr. Caplan will not be paid in his work in the program.
Caplan believes there needs to be a better system for deciding what’s fair and which patients are granted access to testing-phase drugs. “If we could structure this right, this would be a chance to not just complain about what’s wrong, but maybe to suggest a way forward,” he said in an interview.
One of the reasons this situation is complicated is because before drugs are approved, there is often a limited supply – even if the FDA gives the OK for distribution of what’s available. Companies then have the difficult decision of figuring out who should be allowed access, how to manage distribution while still conducting sufficient clinical trials, and how to make sure they don’t run out. Not only that, there is always still a risk that the drugs won’t work or could actually cause harm.
“There’s no stock answer — yes or no, black or white,” said Richard Klein, director of the F.D.A.’s patient liaison program. “Maybe you can take that responsibility off the company.”
The decisions that must be made by drug makers aren’t easy in a lot of cases, but having an educated and unbiased panel on board is great first step that will inevitably save some lives.
