Yin’s paper reveals a by-product of the Orphan Drug Act (ODA); an act that was supposed to (and has) help develop drugs for rare diseases. Yin calls the unintended effect of the ODA “balkanization.” Essentially balkanization is when a drug company creates a new rare disease that is actually just a derivative of an already well-established disease.
I find that 25-percent of all clinical trials induced by the ODA represent balkanization. While limiting off-label drug use may be impractical, reducing balkanization by imposing a fee when an orphan drug reaches a trigger level of off-label sales may be viable. Extending the moral hazard analogy, the fee or tax repayment can serve as a “co-payment” to reduce the incentives to balkanize. At the same time, co-payments also create a disincentive for firms to develop drugs for previously unconsidered alternative uses (true R&D externalities). More creative solutions may be able to limit social waste without extensive cost to innovative activity.
If you care about economics and/or healthcare, this paper might be worth your time. Or at least, just giving a couple minutes to think about “balkanization” could be worth your time.