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I have a relatively rare disease, and just recently discovered that a drug helps me with some of my symptoms. The drug is not approved by the FDA for how I am using it.

Who do I contact, and how do I contact them, to get the research done so that this drug can become approved by the FDA for how I am using it?

  • What disease? do you already have an idea about how to develop a treatment? – virtualxtc Oct 21 '18 at 15:55
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You can contact the FDA from their website, fda.gov.

Since you're a patient with a disease, I would use the FDA Patient Network Program.

Office of Health and Constituent Affairs: 301-796-8460; email: PatientNetwork@fda.hhs.gov

Please note that your doctor does not need FDA approval to use a drug in an off-label manner.

Can there be any problems for doctor if a drug is prescribed for conditions that are not on the label or FDA-approved?

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    It will be helpful if you can explain a little more on off-label use of drugs. Can there be any problems for doctor if a drug is prescribed for conditions that are not on the label or FDA-approved? – rnso Sep 16 '15 at 1:03
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    @mso - Can you please ask that in a separate question? It's a good question and deserves more than an aside. – anongoodnurse Sep 16 '15 at 4:00
  • I don't want to explain much more than I have as I must now obtain the drug without a prescription. I do not like having to bend the law in order to get by with the symptoms of my disease. I would prefer to obtain the drug through a pharmacy even if it more expensive that way. My doctor tells me that he is prohibited from prescribing the drug that I am using. – Jack Swayze Sr Sep 16 '15 at 6:47
  • @anongoodnurse : Please see this new question: health.stackexchange.com/questions/3144/… – rnso Sep 16 '15 at 7:09
  • NBR has a relevant story on the prices of drugs nbr.com/2015/09/16/… – Jack Swayze Sr Sep 17 '15 at 0:43

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