Orphan Drug Fairness Act

Bill: 114-hr-3618
Sponsor: full_name: Rep. Lance, Leonard [R-NJ-7]
Introduced: 2015-09-25
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Drug therapy

Income tax credits

Prescription drugs

User charges and fees
Latest action: action_date: 2015-10-02
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-09-25
action_desc: Introduced in House
text: <p><b>Orphan Drug Fairness Act</b></p> <p>This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million. </p> <p>This Act is effective as if included in PPACA. </p>

tv_txt: I 114th CONGRESS 1st Session H. R. 3618 IN THE HOUSE OF REPRESENTATIVES September 25, 2015 Mr. Lance (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 ).