Pharma companies don’t have to comply. Large pharmaceutical companies are notoriously risk averse when it comes to expanding access to medications that are still in the testing phase. Many refuse to grant access to investigational drugs outside of clinical trials, and efforts to lobby them to release the medication as part of compassionate use are often rebuffed

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At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind. It would allow terminally ill patients access to experimental drugs without the approval of the FDA. But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves

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David Kroll writes, “In 1984, when I was a junior in college and my sister a junior in high school, my then-44-year-old mother was diagnosed with an aggressive form of breast cancer. I would have done anything for her then, and continued to do so until she died on Dec. 9, 2017, in her bed at her home in Santa Fe, New Mexico, some 33 years after her initial diagnosis.”

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Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks harming patients’ health

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If you were dying, surely you would grasp at any chance medicine might offer you. Recently, there has been a lot of effort at the state and federal levels to try to increase patient access to experimental drugs. The approach has been to cut the FDA out of what is known as “compassionate use”

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What Experimental Drug?

October 11, 2016

Most companies don’t post compassionate use policies

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With drug companies’ policies hard to decipher, frustrated patients often resort to social-media campaigns and other public appeals

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Johnson & Johnson has appointed Arthur Caplan, a nationally known bioethicist, to create a panel that will make decisions about patients’ requests for potentially lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved

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