Right to try was just a photo op, and trying to make Trump look

Discussion in 'Healthcare/Insurance/Govt Healthcare' started by Penelope, May 31, 2018.

  1. Penelope
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    Penelope Platinum Member

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    compassionate.
    ----------------------------------------------------

    What to Expect After Submitting a Request for Expanded Access to an Investigational Drug (Including a Biologic) Under a Single Patient IND

    · FDA authorizes over 99% of expanded access requests it receives.

    · Treatment may begin 30 days after FDA receives the IND, or earlier if FDA notifies the treating physician that the expanded access use may begin. The treating physician must ensure that IRB review is obtained in accordance with FDA’s regulations.

    · The treating physician may need to provide the IND application number to the medical product company prior to the company shipping the investigational drug. This number will be provided upon FDA authorization of the expanded access request.

    Expanded Access (Compassionate Use)
    -----------------------------------------------------------------

    Dead On Arrival: Federal “Compassionate Use” Leaves Little Hope for Dying Patients | Right to Try - National Movement

    Right to try has already been passed by many states, nothing new here. Also the med has to go under the first clinical trial.

    So are insurance companies going to pay for the med, NO.
    Will drug companies make new meds and pass them out to the dying, probably not. LAWSUITS.

    ---------------------------------------------------------------

    Trump made no laws just signed a bill to make it federal and most states have it anyway. Just a photo op for Trump.

    This leaves drug companies to pass out pills like sugar , well after a first clinical trial.
    But if you are going to die, why not try all the chemicals you want. You will still need a doctor to follow you but accurate reporting will not be done under the FDA probably, just bypassing the FDA.
    Be careful.
     
    Last edited: May 31, 2018
  2. Penelope
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    President Donald Trump is slated to sign the controversial "right-to-try" bill on Wednesday, which would bypass drug regulators to give gravely ill patients access to experimental medicines.

    The legislation allows patients with life-threatening conditions to ask drugmakers for medicines that have cleared some testing but still haven't been approved by the Food and Drug Administration. Previously, people would need to ask the FDA for access to experimental treatments.

    Trump and Vice President Mike Pence had been major supporters of passing the measure, which supporters say gives patients hope they would not otherwise have. The House of Representatives approved the bill last week, which is the same version the Senate passed in August.

    It allows certain patients to ask drugmakers for medicines that have passed Phase 1 of the FDA approval process but haven't been approved yet and are still undergoing testing. Patients must have exhausted other options and be unable to participate in a clinical trial.

    Critics say the legislation undermines the FDA's authority to regulate drugs and could leave patients vulnerable to medicines that might not work or even be harmful. The agency already runs an "expanded access" program where seriously ill patients can apply to access experimental treatments.

    Commissioner Scott Gottlieb has said the agency has grants 99 percent of these requests.

    Under the legislation, drugmakers aren't obligated to give patients the requested experimental medicines.

    Watch Trump sign 'right-to-try,' allowing gravely ill patients to bypass FDA for experimental treatment
     
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