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According to research of the 197 new FDA approved drugs since 1997, the chance of a generic drug getting approval for a new indication drops to almost zero afte

by savvak 5y ago

According to research of the 197 new FDA approved drugs since 1997, the chance of a generic drug getting approval for a new indication drops to almost zero after it goes off-patent/generic - see https://pubmed.ncbi.nlm.nih.gov/33397471/ https://pubmed.ncbi.nlm.nih.gov/33397471/. I assume your drug was still on-patent and/or was not subject to off-label competition? Otherwise, how did you get funding? The issue of the lack of private incentives to repurpose off-patent drugs (i.e. "financial orphans") is very well recognised, irrespective of section 505(b)(2) of the FDCA - see https://www.healthaffairs.org/do/10.1377/hblog20140306.037370/full/ https://www.healthaffairs.org/do/10.1377/hblog20140306.03737...

gumby 5y ago
This is a very good point. You figure out a new use for a generic drug, then anyone can use the generic in that way. We also (I mentioned this in a comment a couple of weeks ago) did some therapeutic development that we realized any compounding pharmacy could make up the formulation. We dropped all work. On our product it was an approved API with different dosage and a different mode of administration. Still in trials, but if approved it will have normal patent protection. Edit: the first “is” was autocorrected into “isn’t”. Glad I saw it!
- savvak 5y ago
  Thanks for correction! Yes, it is possible to reformulate a generic but there's only a business model if you can prevent off-label competition (and a compounding pharmacy could also reformulate). This is what I mean by information about a treatment protocol for a repurposed generic / off-patent drug being a public good. What if your new use for the off-patent and or compounded drug was a very effective new treatment or cure for an unmet medical need? This is the real tragedy of the commons. It's not always possible to rely on reformulations, dosage or mode of administration to prevent generic competition, and could actually cause public harm if the patented reformulation of the drug is less safe or effective - see https://www.nature.com/articles/s41587-021-00999-0 https://www.nature.com/articles/s41587-021-00999-0 . And it's possible to fix it with a pay for success or bounty model, as long as we can convince a payer agree to put a price on successful off-patent RCT data (e.g. $10-50k per QALY). However, this hasn't been tried to date.
  - tuxguy 5y ago
    Insightful discussion !

by savvak 5y ago

gumby 5y ago

This is a very good point. You figure out a new use for a generic drug, then anyone can use the generic in that way. We also (I mentioned this in a comment a couple of weeks ago) did some therapeutic development that we realized any compounding pharmacy could make up the formulation. We dropped all work. On our product it was an approved API with different dosage and a different mode of administration. Still in trials, but if approved it will have normal patent protection. Edit: the first “is” was autocorrected into “isn’t”. Glad I saw it!

savvak 5y ago
Thanks for correction! Yes, it is possible to reformulate a generic but there's only a business model if you can prevent off-label competition (and a compounding pharmacy could also reformulate). This is what I mean by information about a treatment protocol for a repurposed generic / off-patent drug being a public good. What if your new use for the off-patent and or compounded drug was a very effective new treatment or cure for an unmet medical need? This is the real tragedy of the commons. It's not always possible to rely on reformulations, dosage or mode of administration to prevent generic competition, and could actually cause public harm if the patented reformulation of the drug is less safe or effective - see https://www.nature.com/articles/s41587-021-00999-0 https://www.nature.com/articles/s41587-021-00999-0 . And it's possible to fix it with a pay for success or bounty model, as long as we can convince a payer agree to put a price on successful off-patent RCT data (e.g. $10-50k per QALY). However, this hasn't been tried to date.
- tuxguy 5y ago
  Insightful discussion !