Senate's OB3 Act overturns the IRA's destruction of 2nd indications for Orphan drugs: Conclusion: Section 71203 of the OB3 Act directly reverses the IRA’s negative impact on orphan drugs by ensuring that drugs with multiple rare disease indications remain exempt from Medicare price negotiations.
It also provides clarity for drugs that transition out of orphan status, delaying price negotiation until they are no longer used solely for rare diseases. This change is likely to restore incentives for developing additional indications for orphan drugs, benefiting both patients and manufacturers."