Sec. 7005. Clarification of orphan drug exception to annual fee on branded prescription pharmaceutical manufacturers and importers

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(3)of section 9008(e) of the Patient Protection and Affordable Care Act (Public Law 111–148) is amended to read as follows: The term branded prescription drug sales shall not include sales of any drug or biological product— with respect to which a credit was allowed for any taxable year under section 45C of the Internal Revenue Code of 1986 (as in effect before its repeal by the Tax Reform Act of 2014 ); or which is approved or licensed by the Food and Drug Administration for marketing solely for one or more rare diseases or conditions. Subparagraph

(A)shall not apply with respect to any drug or biological product after the date on which the 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. For purposes of this paragraph, the term rare disease or condition means any disease or condition which— affects less than 200,000 persons in the United States, or affects more than 200,000 persons in the United States but for which there is no reasonable expectation that the cost of developing and making available in the United States a drug or biological product for such disease or condition will be recovered from sales in the United States of such drug or biological product. Determinations under the preceding sentence with respect to any drug or biological product shall be made on the basis of the facts and circumstances as of— in the case a drug or biological product that has been designated under section 526 of the Federal Food, Drug, and Cosmetic Act for a particular indication, the date of such designation, and in any other case, the date such drug or biological product is approved or licensed by the Food and Drug Administration for marketing for the treatment of the disease or condition referred to in clause (i). . The amendment made by this section shall apply to fees imposed under section 9008(a)(1) of the Patient Protection and Affordable Care Act with annual payment dates after 2013.

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Pub. L. 111-148

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Sec. 7005

Clarification of orphan drug exception to annual fee on branded prescription pharmaceutical manufacturers and importers

Pub. L.Pub. L. 111-148

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