Johnson & Johnson Creating An Independent Panel To Review Patient Requests For Unapproved Drugs

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(Scoboco)

What’s a sick person to do when all the drugs on the market haven’t been able to help ease their ailment? Some of the seriously ill turn to medical trials held by drug companies to gain access to experimental drugs, but it’s not always easy to accomplish. A new system from Johnson & Johnson will employ an independent panel to review requests from seriously ill people who want to try an unapproved drug without participating in the actual testing of the drug.

According to a report by the Wall Street Journal, this committee of doctors, bioethicists and patient representatives will work under the umbrella of the New York University School of Medicine, and will field the hundreds of requests J&J receives each year from patients who want to try an experimental drug.

Physicians from J&J will first check if a patient could be included in a clinical trial or another early-access program, and if not, the request will be sent on to the independent panel. The company says while it might veer from what the panel advises, it expects it’ll take the committee’s advice.

At that point, the patient would still have to get what’s known as “compassionate use” clearance from the Food and Drug Administration. Regulators and companies have been getting more requests for this early access to unapproved drugs, with up to 1,809 such requests last fiscal year, according to the FDA.

But both the agency and drug companies have been accused of resisting requests, though the FDA says it’s allowed more than 99% of the compassionate-use requests it received in the last several years. Even after the FDA has approved a patient, it’s still up to the company to say yes or no.

The way it works now, it’s usually up to individual physicians working around the company on various drugs to decide if a patient should qualify. There are fears that if a patient tries an unapproved rug and it doesn’t work or they experience serious side effects, they could sue its makers.

“This really assures each request is handled in an objective and thoughtful manner,” said J&J Chief Medical Officer Joanne Waldstreicher.

Critics of J&J’s new panel include advocates for “Right to Try” laws like the Goldwater Institute that believe regulators shouldn’t have as much power over which drugs terminally ill patients have access to. The company’s CEO Darcy Olson tells the WSJ she doesn’t think the panel will make it easier or faster for patients to get their hands on the medicines they seek.

“What I think you have is J&J passing the buck on tough decision-making,” she said.

On the other hand, the chief medical officer of J&J’s Janssen pharmaceuticals unit says the system of having a single website and toll-free hotline for requests will be much easier for patients, instead of having them go through the myriad of entry points at J&J for its drug trials. He says he expects recommendations from the committee in a matter of day for urgent requests.

J&J Changes ‘Compassionate’ Care [Wall Street Journal]

by Mary Beth Quirk via Consumerist