Section 1 Short title
This Act may be cited as the “Orphan Drug Fairness Act”.
Orphan Drug Fairness Act
A BILL
To clarify the exclusion of orphan drug sales from the calculation of the annual fee on branded prescription pharmaceutical manufacturers and importers, and for other purposes.
Sec. 2 Exclusion of orphan drug sales
In general— Paragraph (3) of section 9008(e) of the Patient Protection and Affordable Care Act (26 U.S.C. 4001 note prec.; Public Law 111–148) is amended to read as follows:
“(3) Exclusion of orphan drug sales—The term branded prescription drug sales shall not include sales of any drug or biological product with respect to which a credit was allowable for any taxable year under section 45C of the Internal Revenue Code of 1986, regardless of whether such credit was claimed and received. The preceding sentence shall not apply with respect to any such drug or biological product after the date on which such drug or biological product is approved by the Food and Drug Administration for marketing for any indication other than the treatment of the rare disease or condition with respect to which such credit was allowable.”
Effective date— The amendment made by subsection (a) shall take effect as if included in section 9008 of the Patient Protection and Affordable Care Act (26 U.S.C. 4001 note prec.; Public Law 111–148).