Preserving Access to Orphan Drugs Act of 2018

Bill: 115-hr-7324
Sponsor: full_name: Rep. Kelly, Mike [R-PA-3]
Introduced: 2018-12-17
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Drug therapy

Health care coverage and access

Prescription drugs

User charges and fees
Latest action: action_date: 2019-01-02
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2018-12-17
action_desc: Introduced in House
text: <p><b>Preserving Access to Orphan Drugs Act of </b><b>2018</b></p> <p>This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) </p>

tv_txt: I 115th CONGRESS 2d Session H. R. 7324 IN THE HOUSE OF REPRESENTATIVES December 17, 2018 Mr. Kelly of Pennsylvania 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 orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers, and for other purposes.

1. Short title This Act may be cited as the Preserving Access to Orphan Drugs Act of 2018 . 2. Clarification of orphan drug exception to annual fee on branded prescription pharmaceutical manufacturers and importers (a) In general Section 9008(e)(3) of the Patient Protection and Affordable Care Act is amended to read as follows: (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 For purposes of 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. . (b) Hold harmless for covered entities with no or limited orphan drug sales Section 9008(b) of the Patient Protection and Affordable Care Act is amended by adding at the end the following new paragraph: (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), then such entity's fee under this section for such calendar year shall be determined as described in subparagraph (B). . (c) Effective date The amendments made by this section shall apply with respect to fees the annual payment date for which under section 9008 of the Patient Protection and Affordable Care Act is after December 31, 2018.