Hello,
I am not sure about the USA and I will leave the colleagues to comment but in Europe where there is a public healthcare systems this is possible.
It is common that physicians can conduct investigator-led studies and generate data to support the use of a drug in different indication (for example, drug for treating a disease is used for prevention of the disease). Then the country regulators can use this data to change their national recommendations. In theory this is 'off label use' but because the regulator in the country have included it in their standard of care guidelines it could be used in the country.
In EU there is even collaborations between different countries to re-purpose existing drugs.
Have a great day,
Olga
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Olga Peycheva
Regulatory and Study Start Up Specialist (Clinical trials)
Solutions OP Ltd
https://solutionsop.co.uk/United Kingdom
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Original Message:
Sent: 16-Jan-2024 13:16
From: Robert Raulli
Subject: An anonymous post for submission
PLEASE POST ANONYMOUSLY
I am aware that FDA has provisions in Title 21 whereby rules can be exempted or relaxed for the public good.
Scenario:
Suppose you were with an academic organization or public health-related non-profit. You had more than sufficient evidence that a generic drug product, with maybe 6 manufacturers, could be repurposed to provide a clear and substantial benefit to public health if it could be approved for a new indication and route of administration via the 505(b)(2) pathway. You had all the real world clinical evidence you need to show safety and efficacy for this new indication and route of administration. It would likely be a paper NDA.
Is there a way for a non-manufacturer (no prior NDA, no NDC number) to file for approval for an indication without any drug product of your own, simply for the public good? Put another way, is there a public health benefit provision to "donate" an indication via 505(b)(2) that would allow any and all manufacturers to add this indication to their label? Would you need to partner with one or several of the manufacturers to gain approval?