ARTICLE | Politics & Policy

Lawmakers petition IRS on PPACA's Orphan exclusion

June 3, 2011 12:12 AM UTC

Members of the Rare Disease Congressional Caucus are asking the Internal Revenue Service to interpret the Patient Protection and Affordable Care Act in a way that would potentially allow more Orphan drugs to qualify for exclusion from the law's annual fee for branded prescription drugs. Co-chairs Joseph Crowley (D-N.Y.) and Leonard Lance (R-N.J.) and 10 other members of the House of Representatives sent a letter asking the IRS to apply the fee exemption to Orphan products for which the most recent FDA approval was for an Orphan indication, regardless of previous approvals, including for non-Orphan indications. ...