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1 correction found
since they can’t establish exclusivity (which limits their potential profit).
This overstates the exclusivity problem. Repurposed or previously approved drugs can still receive FDA exclusivity in some circumstances, including 3-year exclusivity for a new indication and 7-year orphan-drug exclusivity.
Full reasoning
The article presents it as a categorical fact that companies repurposing existing drugs “can’t establish exclusivity.” FDA materials contradict that.
FDA explains that a previously approved active ingredient can receive 3 years of new clinical investigation exclusivity when new clinical studies support approval for a different disease or condition. FDA also explains that the first sponsor to obtain approval of a drug for a qualifying rare-disease indication is generally eligible for 7 years of orphan-drug exclusivity.
So it is fair to say that repurposed generic drugs often have weaker or less reliable exclusivity incentives than brand-new drugs. But it is not correct to say companies simply cannot establish exclusivity at all.
2 sources
- Exclusivity and Generic Drugs: What Does It Mean? | FDA
“A brand-name drug with an active ingredient that has been approved before may be awarded a three-year exclusivity in certain circumstances, such as if ... a different disease or condition the drug can treat is identified.”
- Frequently Asked Questions (FAQ) About Designating an Orphan Product | FDA
“The first sponsor to bring an active moiety to market for a particular use or indication is generally eligible for orphan drug exclusivity if that sponsor has orphan designation for that drug.”