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Thread: House to try again on bill easing use of unapproved drugs

  1. #1

    House to try again on bill easing use of unapproved drugs

    The House plans to try anew next week to approve a Republican bill making it simpler for fatally ill people to try unproven treatments. And this time, the measure seems certain to pass.

    Lawmakers voted for the legislation on Tuesday by a lopsided 259-140 vote. But it lost because GOP leaders had used a procedure, normally reserved for uncontroversial bills, that requires a two-thirds majority for passage. Tuesday's vote fell just short of that.

    President Donald Trump backed the legislation and GOP lawmakers lined up behind it nearly unanimously, but Democrats opposed it by more than a 4-1 margin.

    Under the measure, the Food and Drug Administration would no longer have to sign off if a doctor and a drug manufacturer agree to let a patient try a pharmaceutical that's not been approved by the federal agency.

    Republicans say the measure would provide hope for patients desperate for any chance of survival.

    More at: https://www.ajc.com/news/national-go...fKfNt9ibQY5YP/
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    The House on Tuesday passed "right to try" legislation that would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications, ending a drawn-out battle over access to unapproved therapies.
    President Donald Trump is expected to quickly sign the measure, which was praised by supporters as a lifeline for desperate patients but denounced by scores of medical and consumer groups as unnecessary and dangerous.
    The Senate passed the bill in August, and the House approved its own version in March. That version was less objectionable to the medical groups, but then the legislation got bogged down. With the White House demanding action, House leaders in recent days decided to short-circuit the process by taking up the Senate-passed bill. The vote was 250 to 169.
    The measure, championed by Sen. Ron Johnson, R-Wis., is designed to give patients an alternative way to obtain drugs not approved by the FDA. Currently, there are two options for patients seeking experimental medications: enrolling in clinical trials if they are eligible or participating in the FDA's "expanded access" program. The agency has said that it approves almost all such requests to that program.
    The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process. Drug manufacturers would have to report "adverse events" — safety problems, including premature deaths — only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval.
    Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.

    More at: http://www.baltimoresun.com/news/nat...522-story.html
    Never attempt to teach a pig to sing; it wastes your time and annoys the pig.

    Robert Heinlein

    Give a man an inch and right away he thinks he's a ruler

    Groucho Marx

    I love mankindÖitís people I canít stand.

    Linus, from the Peanuts comic

    You cannot have liberty without morality and morality without faith

    Alexis de Torqueville

    Those who fail to learn from the past are condemned to repeat it.
    Those who learn from the past are condemned to watch everybody else repeat it

    A Zero Hedge comment



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