What is Right to Try?

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TimGDixon
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What is Right to Try?

Post by TimGDixon »

What is Right to Try?
• Right to Try is one pathway for patients diagnosed with life-threatening diseases or conditions who have exhausted all approved treatment options and are unable to participate in a clinical trial to access certain drugs that have not been approved by the Food and Drug Administration (FDA).
• Right to Try allows eligible patients to request access to certain investigational drugs (including biologics ) that have not yet been approved by the FDA.
• Under Right to Try, patients and their doctors work with a company that is developing a drug or biologic to request access without involving FDA in the process.
• The FDA does not review or approve Right to Try requests.

How do I know if I am eligible to request access to a drug or biologic under Right to Try?
Patients who are eligible under the Right to Try Act meet the following criteria:
• You have a life-threatening disease or condition.
• You have exhausted approved treatment options and are unable to participate in a clinical trial involving the drug or biologic, as certified by your doctor.
• You (or your legally authorized representative) have given written informed consent to the doctor regarding the investigational drug.

How do I know if a drug or biologic is available under Right to Try?
• The Right to Try Act sets forth specific criteria for a drug or biologic to be eligible for this pathway, such as a drug or biologic being under clinical trial investigation.
• The Right to Try Act does not require a manufacturer or sponsor to provide access to drugs or biologics. Further, FDA cannot require a manufacturer or sponsor to provide access to drugs or biologics under the Right to Try Act.

What else do I need to know about Right to Try?
• Through the Investigational New Drug (IND) application process, the FDA typically reviews the safety of each proposed use of an investigational new drug before it can be provided to patients. While the Right to Try Act requires drugs to meet specific criteria in order to be eligible to be provided to patients under the Right to Try pathway, drugs that are provided through the Right to Try pathway are generally exempt from these IND reviews.
• Drugs and biologics available under Right to Try have not been approved by the FDA.

This means that:
o Safety: The FDA has not determined whether drugs and biologics made available under Right to Try are safe and if there could be serious risks or side effects.
o Effectiveness: The FDA has not determined whether drugs and biologics made available under Right to Try can lead to any improvement in disease or symptoms.

• Discuss the potential benefits and risks of receiving drugs through Right to Try with your doctor.

For more information:
• Right to Try: https://www.fda.gov/patients/learn-abou ... /right-try
• Clinical Trials: https://www.fda.gov/patients/clinical-t ... -need-know
• FDA’s Drug Review Process: https://www.fda.gov/drugs/drug-informat ... -effective
jaybwatts71
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Re: What is Right to Try?

Post by jaybwatts71 »

Thanks Tim
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TimGDixon
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Re: What is Right to Try?

Post by TimGDixon »

You're welcome.
DailyStockProspector
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Joined: Sat Apr 03, 2021 4:14 am

Re: What is Right to Try?

Post by DailyStockProspector »

Hi Tim,

I clicked on the link that you put for the Right to Try and it to a page that said Page Not Found. I think that your link should have been: https://www.fda.gov/patients/learn-abou ... /right-try , but please check it to make sure. I think that your link was missing the dash between treatment and options before the slash right-try.

YOURS: https://www.fda.gov/patients/learn-abou ... /right-try (note the missing dash.
CORRECT LINK SHOULD BE (please verify, and forgive me if it is not the right one):
https://www.fda.gov/patients/learn-abou ... /right-try (has the dash)

I am adding this here in case you use that great write-up elsewhere and happen to include the non-working link.

By the way, super amazing job on today's news! Amazing days ahead!
Go team TSOI! :-)
DailyStockProspector
Posts: 26
Joined: Sat Apr 03, 2021 4:14 am

Re: What is Right to Try?

Post by DailyStockProspector »

Hi Tim,

I just clicked on the other link to and I think it has a similar issue. It looks like it was missing a dash too and the link went to a Page Not Found. I think that the correct link should be "https://www.fda.gov/drugs/information-c ... -effective"
https://www.fda.gov/drugs/information-c ... -effective but once again, please check to make sure. Thanks.

Our prayers are with you! You and your team rock!
DailyStockProspector
Posts: 26
Joined: Sat Apr 03, 2021 4:14 am

Re: What is Right to Try?

Post by DailyStockProspector »

Hi Tim, me again. I looked closer at the RTT page from the FDA and found that it included a sentence that says "The full text of the Right to Try Act, Public Law 115-176, can be found on US Congress’s website: Public Law 115-176." and it includes a link that points to this page: https://www.congress.gov/115/bills/s204 ... 204enr.pdf . Is that the document that you were looking for?

I noticed that the act was dated Jan 3, 2018, (at the top of the page) and it goes on to say: "This Act may be cited as the ‘‘Trickett Wendler, Frank
Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017’’." Part way down it includes verbiage that discusses the issue of liability. I am not sure if this is what you were looking for and if it is not, please add a note correcting me in the forum.

I also found this reference link: https://www.congress.gov/bill/115th-con ... l/204/text Once again, I am not sure if this is the right link or what you are looking for and please forgive me if it is not.

I do not want people to use the wrong doc or docs/link if this/these is/are not the right one(s). I simply tried to get to the RTT page on the FDA site, using a link that was closest to the one you had in your previous post and I clicked on the link that was on that page. I hope that this helps.

Go team TSOI! :-)
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TimGDixon
Posts: 2293
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Re: What is Right to Try?

Post by TimGDixon »

I just copied and pasted and apparebtly the links got messed up - they work fine from here: https://therapeuticsolutionsint.com/eind-rtt-eua/
DailyStockProspector wrote: Mon Oct 11, 2021 11:49 pm Hi Tim,

I clicked on the link that you put for the Right to Try and it to a page that said Page Not Found. I think that your link should have been: https://www.fda.gov/patients/learn-abou ... /right-try , but please check it to make sure. I think that your link was missing the dash between treatment and options before the slash right-try.

YOURS: https://www.fda.gov/patients/learn-abou ... /right-try (note the missing dash.
CORRECT LINK SHOULD BE (please verify, and forgive me if it is not the right one):
https://www.fda.gov/patients/learn-abou ... /right-try (has the dash)

I am adding this here in case you use that great write-up elsewhere and happen to include the non-working link.

By the way, super amazing job on today's news! Amazing days ahead!
Go team TSOI! :-)
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