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Msg  49985 of 50378  at  10/17/2019 8:47:48 AM  by


 In response to msg 49984 by  GaryM
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Re: it still amazes me that

"As I understand the right to try, there are many reasons someone could choose it over a clinical trial, if one were available for the precise disease that they had."
As you previously noted the most limiting factor preventing more use of right to try is that participation by drug companies is voluntary.  RTT is intended for patients who have exhausted all other possible avenues of treatment, including clinical trials, so having the option of choosing between an available clinical trial and RTT should not really be a player in this scenario.  RTT has not caught on for various reasons.  The act was intended to cut FDA out of the process of making unapproved drugs available, but as it turns out, drug companies and physicians appear to be more comfortable with FDA sanctioned expanded access than with the less regulated RTT.  The following is a cut and paste from FDA's description of RTT eligibility requirements..

"An eligible patient is a patient who has:

  • Been diagnosed with a life-threatening disease or condition
  • Exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (this must be certified by a physician who is in good standing with their licensing organization or board and who will not be compensated directly by the manufacturer for certifying)
  • And has provided, or their legally authorized representative has provided, written informed consent regarding the eligible investigational drug to the treating physician"

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Msg # Subject Author Recs Date Posted
49988 Re: it still amazes me that GaryM 1 10/17/2019 4:00:31 PM

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