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Compliance In Focus
Posted by Matt Carandang on Thu, Nov 5, 2020

New Reporting Requirements Under the Right to Try Act

 


The  Right to Try Act greatly expands access to eligible investigational drugs which are not yet FDA approved but could potentially help a patient with a terminal illness.

Right-to-Try

 

The Act was signed into law in May 2018. The FDA recently released proposed, annualized reporting requirements associated with the Right to Try Act to provide federal oversight of eligible patients.

This will require a sponsor or manufacturer of eligible investigational drugs to prepare and submit specific documentation to remain in compliance.

Right To Try Act: 3 Questions

 

Who is responsible for preparing reports?

The sponsor or manufacturer of an eligible investigational drug is responsible for preparing the required report. Your drug may be considered an eligible investigational drug if it meets the following criteria:

  • Phase 1 clinical trial has been completed
  • Has not been approved or licensed by the FDA for any use
  • An application has been filed with the FDA or is under investigation in a clinical trial that is supposed to demonstrate the primary basis of a claim of efficacy in support of FDA approval and is the subject of an active investigational new drug application submitted to the FDA
  • Active development / production is current without discontinuation by the manufacturer or on clinical hold by the FDA

If your drug meets these criteria, then it could be distributed to eligible patients, including those who:

  • Are diagnosed with a terminal disease or condition;
  • Have exhausted approved treatment options and are unable to participate in the clinical trial involving the eligible investigational drug (certified by a physician who will not be compensated directly by the manufacturer for the certification); or
  • Can give, or have their legally authorized representative give, written informed consent regarding the eligible investigational drug to the treating physician.

The FDA gives sponsors and manufacturers discretion to whom they provide their eligible investigational drug, but they are required to submit an annual report to the FDA to document the drug’s provision and use.

What are the elements of the report?

There are five essential elements of the report according to the proposed reporting requirements of the Right to Try Act which will need to be prepared for the FDA.

  1. The name of the eligible investigational drug and its applicable IND number
  2. The total number of doses supplied to patients
  3. The total number of patients treated
  4. The use(s) for which the eligible investigational drug was made available and the number of patients for each use
  5. Any known serious adverse events (SAEs) and their respective outcomes

The FDA does not require an itemized log for the doses supplied or for the patients treated, just the total number of doses supplied and total number of patients treated (no matter their dosage). Tabular summaries have been proposed as a method of documenting the eligible investigational drug use(s) and any known SAEs. These can be separate tables or combined together.

The FDA provided an example of a combined table within its proposal, in the Annual Summary Reporting Requirements Under the Right to Try Act. For reporting SAEs, the FDA proposes that the sponsor use a subject ID number to identify the patient, so as to secure patient privacy.

When are the reports due?

Under the proposed reporting requirements, the first report will be due to the FDA 60 days after the rule has been finalized and will cover the period of May 30, 2018 (the date the Act was signed into law) to the date of the finalization of the rule. The following reports will be annualized and will be due on March 31 each year. Reports should cover the previous year from January 1 to December 31.

Hiring A Contract Research Organization - 20 Questions

Need Help With Right To Try Act Reporting?

Do you need help preparing a report like this? Comment below or contact us for expert advice about compiling documentation for your eligible investigational drug so more eligible patients can be treated.

We are a full service CRO, with a team of monitors, auditors, and experienced clinical research professionals ready to provide comprehensive support, from planning to post-market data collection.

What do you think of the new annualized reporting requirements under the Right to Try Act? How might this impact eligible patients in need? Please leave a comment below.

Sources:

  1. 1. Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. S.204. 115th Cong (2017-2018). https://www.congress.gov/115/bills/s204/BILLS-115s204enr.pdf
  2. U.S. Department of Health and Human Services, Food and Drug Administration. “Annual Summary reporting Requirements Under the Right to Try Act.” Federal Register, 24 July 2020, https://www.federalregister.gov/documents/2020/07/24/2020-16016/annual-summary-reporting-requirements-under-the-right-to-try-act

2. 21 USC 360bbb: (2016). https://uscode.house.gov/view.xhtml?req=(title:21%20section:360bbb%20edition:prelim)#sourcecredit

Topics: The Right to Try Act

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