Preserving Access to Orphan Drugs Act of 2015

“(3) Exclusion of orphan drug sales

“(A) In general—The term branded prescription drug sales shall not include sales of any drug or biological product—

“(i) with respect to which a credit was allowed for any taxable year under section 45C of the Internal Revenue Code of 1986;

“(ii) with respect to which a credit was allowable for any taxable year beginning before January 1, 2011, under such section 45C (without regard to whether such credit was claimed or received); or

“(iii) which was any drug or biological product approved or licensed prior to January 1, 2011, by the Food and Drug Administration, for marketing solely for 1 or more rare diseases or conditions.

“(B) Expiration—Subparagraph (A) shall not apply with respect to any drug or biological product after the date on which such drug or biological product is approved or licensed by the Food and Drug Administration for marketing for any indication other than the treatment of a rare disease or condition.

“(C) Rare disease or condition—In this paragraph, the term rare disease or condition has the meaning given such term under section 45C(d)(1) of the Internal Revenue Code of 1986.”

“(5) Adjustment for certain covered entities with no or limited orphan drug sales—If—

“(A) the fee under this section for a calendar year with respect to a covered entity (determined without regard to this paragraph), exceeds

“(B) the fee that would be determined under this section for such year with respect to such entity if branded prescription drug sales of all covered entities were determined without regard to clauses (ii) and (iii) of subsection (e)(3)(A),”