J&J to Consult Ethics Panel for 'Compassionate Use' Requests

May 08, 2015

Drug manufacturer Johnson & Johnson (J&J) is turning to an independent panel of experts for recommendations on "compassionate use" requests for scarce investigational drugs, the company announced yesterday.

J&J said that its Compassionate-Use Advisory Committee (CompAC) sets a precedent in the pharmaceutical industry.

A bioethicist who heads the panel said it will bring objectivity, wisdom, and order to a process sometimes characterized by chaos.

"A systematic approach to tough decision-making is the best way to go," said Art Caplan, PhD, director of medical ethics at the New York University Langone Medical Center in a Medscape blog (Dr Caplan is a contributing author and advisor for Medscape).

Compassionate use is another name for expanded access programs (EAPs) regulated by the US Food and Drug Administration. A physician can ask the administration to make an unapproved, investigational drug available to a patient outside of a clinical trial, but first the physician must secure the cooperation of the manufacturer, which may say no, particularly if it does not have enough of the investigational drug to spare from a clinical trial. Desperate patients and their families have used social media, local television stations, and their congress members to pressure drug companies to say yes.

"That's not a system," said Dr Caplan. "It basically rewards the squeakiest wheel."

Dr Caplan said J&J reached out to him for a better way to handle compassionate use requests. The result was a formal partnership between the company's Janssen Pharmaceutical subsidiary and the New York University School of Medicine, which is establishing the 10-member advisory committee. CompAC will consist of bioethicists such as Dr Caplan, physicians, and patient representatives with a background in consumer advocacy.

The committee fits into the tail end of Janssen's process for reviewing requests for investigational drugs through a clinical trial or an EAP, according to a news release from J&J. Janssen can approve patients for an EAP if they have same condition the drug is intended to treat and have exhausted all other treatment options. If a patient does not qualify for an EAP or a clinical trial, his or her request goes to CompAC.

J&J spokesperson Larry Thompson told Medscape Medical News that some of the "hard cases" coming to the committee may involve conditions that do not exactly match the proposed indication of an investigational drug, but still might respond to it. Related cancers are one example.

CompAC will recommend a course of action to Janssen, which will make the final decision.

All requests funneled to the committee will be rendered anonymous.

"It doesn't matter whether you're rich or poor, American or non-American," said Dr Caplan. "All that matters is your medical need."

J&J said that CompAC will begin as a pilot project handling requests for a single investigational drug in the Janssen portfolio. Spokesperson Larry Thompson declined to say which drug it is. If the project succeeds, J&J will use it as a companywide model.

More information about yesterday's announcement by J&J is available on the company's website.

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