Whereas the Inflation Discount Act (IRA) goals to decrease the costs of prescription drugs, on the identical time it exempts medication treating uncommon illnesses (i.e., orphan medication) from drug worth negotiation. Nonetheless, this exemption is simply legitimate if the orphan medication has a single permitted indication. Thus, a key query is how often orphan medication are later developed for different indications. If that’s the case, IRA may may de-incentivize R&D investments in new indications for orphan medication.
A brand new paper by Chambers et al. (2023) in JAMA Community Open FDA approval database between 2003 and 2022 to see how frequent new indications are for orphan medication. They discover that:
FDA permitted 282 novel orphan medication from 2003 to 2022…Total, the FDA permitted 152 separate follow-on indications; 92 (61%) of those follow-on indications had been additionally for orphan drug circumstances. The imply (SD) time from novel orphan drug approval to follow-on indication was 53 (43) months…FDA included 58 (38%) follow-on indications in a single expedited overview program, 46 (30%) in 2 applications, and 17 (11%) in 3 applications; none had been included in all 4 applications.
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