• Regulatory NewsRegulatory News

    Trump Signals Support for 'Right-to-Try' Movement

    In a meeting with pharmaceutical industry executives on Tuesday, President Donald Trump expressed his concern that the US Food and Drug Administration (FDA) is standing in the way of terminally ill patients accessing unapproved drugs as treatments of last resort. "One thing that's always disturbed me, they come up with a new drug for a patient who is terminal, and the FDA says 'we can't have this drug used on the patient.' But they say, 'But the patient within four weeks...
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    Expedited Compassionate Use for Investigational Drugs Coming Soon, FDA Says

    The fight over patients gaining access to investigational drugs via the compassionate use process is expected to get a lot easier in the near future, just as the US Food and Drug Administration’s (FDA) nonprofit arm, the Reagan-Udall Foundation (RUF), is working to build an online navigator to help patients and physicians understand that process better. Compassionate use, also known as expanded access, is a process by which physicians can request that FDA allow the use o...
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    FDA’s Nonprofit Arm Plots Out New Compassionate Use Navigator

    Patients and physicians desperate for access to a potentially life-saving investigational drug will be able to take some solace in the fact that the US Food and Drug Administration’s (FDA) nonprofit, known as the Reagan-Udall Foundation, is currently working on an online tool to help aid the process of obtaining what are known as "compassionate use" or "expanded access" treatments. The small foundation, which is currently operating with six employees, has drafted a plan ...
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    Congressional Hearings Focus on Compassionate Use, FDA Issues

    Aside from Thursday’s summit on President Barack Obama’s Precision Medicine Initiative (which can be viewed in its entirety  here ), the Senate and House held two other hearings focused on the inner workings of the US Food and Drug Administration (FDA). At the Senate Homeland Security and Government Affairs Committee hearing, senators discussed FDA’s compassionate use program with the Goldwater Institute’s Dary Olsen, who’s been behind all of the Right-to-Try state legi...
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    California Governor Vetoes Right-to-Try Bill, Points to FDA Compassionate Use Program

    California Gov. Jerry Brown (D) on Sunday vetoed a bill that would've allowed a pharmaceutical company to make an investigational drug available to a patient with a terminal illness on the recommendation of two physicians. Brown explained in a message with his decision that the so-called "Right to Try" (RTT) legislation is intended to help patients with life-threatening conditions, and in some cases these patients can already gain access to experimental treatments under ...
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    'Right to Try' Legislation Tracker

    Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use ," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for...
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    Laws Spreading That Allow Terminal Patients Access to Experimental Drugs

    Earlier this month, Arizona voters  approved a referendum  that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year. Supporters say the laws give dying patients faster access to potentially life-saving therapies than the Food and Drug Administration’s existing  “expanded-access” program , often referred to as “compassionate use.” But critics charge they’re feel-good laws that don’t addre...