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H.R. 3618 (114th): Orphan Drug Fairness Act

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The text of the bill below is as of Sep 25, 2015 (Introduced).

I

114th CONGRESS

1st Session

H. R. 3618

IN THE HOUSE OF REPRESENTATIVES

September 25, 2015

(for himself, Mr. Pascrell, Ms. Linda T. Sánchez of California, Mr. Tiberi, and Mr. Holding) introduced the following bill; which was referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

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.

1.

Short title

This Act may be cited as the Orphan Drug Fairness Act.

2.

Exclusion of orphan drug sales

(a)

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.

.

(b)

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).