H. R. 2315
IN THE HOUSE OF REPRESENTATIVES
June 11, 2013
Mr. Gerlach (for himself and Mr. Neal) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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
To clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers.
This Act may be cited as the
Preserving Access to Orphan Drugs Act
Clarification of orphan drug exception to annual fee on branded prescription pharmaceutical manufacturers and importers
Paragraph (3) of section 9008(e) of the Patient Protection and Affordable Care Act (Public Law 111–148) is amended to read as follows:
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 allowed for any taxable year under section 45C of the Internal Revenue Code of 1986; 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.
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, except that in the case of any drug or biological product that has not been designated under section 526 of the Federal Food, Drug, and Cosmetic Act for a particular indication, determinations under such section 45C(d)(1) shall be made on the basis of the facts and circumstances as of the date such drug or biological product is approved or licensed by the Food and Drug Administration for marketing for the treatment of such disease or condition.
The amendment made by this section shall take effect as if included in section 9008 of the Patient Protection and Affordable Care Act ( Public Law 111–148 ).