Fixing the IRA’s orphan exemption 

The chances of persuading Congress to enact sweeping changes to the Inflation Reduction Act’s Medicare drug price negotiation program are negligible, but patient advocates and biopharmaceutical industry lobbyists believe they can, over time, get one aspect of the program modified. Rare disease groups, companies that develop and manufacture orphan drugs and their trade associations are building a movement that they believe can lead to reforms to the IRA’s orphan drug provisions.

Enacting any changes to the IRA will take time and can only be achieved with bipartisan support. To be successful, the issue must be perceived by members of Congress first and foremost as a matter of importance to patients and constituents and not primarily as a way to help biopharmaceutical companies, according to current and former congressional staff. ...