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Rare Disease OPEN-ing In PDUFA Possible For Drug Repurposing Advocates

 
• By Sue Sutter

OPEN ACT would provide additional six months of exclusivity when existing drugs are approved for rare diseases; congressional debate over the measure could get bogged down in drug pricing issues.

Sunrise in Snowy Mountains

Rare disease advocates on Capitol Hill will push hard to get a new incentive program for drug repurposing included in the FDA user fee renewal package that must move through Congress in the next few months.

However, congressional debate on the Orphan Product Extensions Now Accelerating Cures and Treatments Act (OPEN ACT) may move beyond the measure’s six-month incentive to issues involving drug pricing and how...

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