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The Nuances of Branded Rx Drug Fee Regulations

14 October 2014

Contract Pharma

On July 24, 2014, the Internal Revenue Service (IRS) released final regulations to implement Section 9008 of the Affordable Care Act (as amended by section 1404 of the Health Care Education and Reconciliation Act), which imposes an annual fee on manufacturers and importers of branded prescription drugs based on their sales under specified federal healthcare programs. The final regulations largely retain the provisions of the temporary and proposed rule that the IRS issued on August 18, 2011, with certain revisions and clarifications described in further detail below. The final regulations became effective July 28, 2014, and are further explained here.

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