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H.R.6611 - Patient Access to Drugs in Shortage Act of 2012
To amend title XVIII of the Social Security Act to promote public notification and provide incentives to reduce drug shortages, and for other purposes.
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Mr. CASSIDY (for himself, Mr. ROONEY, Mr. ROGERS of Michigan, Mr. HARRIS, and Mr. BENISHEK) 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 concernedCommentsClose CommentsPermalink
SECTION 1. SHORT TITLE.
SEC. 2. MARKET STABILITY INCENTIVES.
‘(i) IN GENERAL- A drug described in this subparagraph is a sterile injectable drug product that is manufactured by 3 or fewer active manufacturers (as determined by the Secretary) and is--CommentsClose CommentsPermalink
‘(I) a multiple source drug (as described in subsection (c)(6)(C)) for which there is no period of exclusivity in effect or available under section 505(j), 505A, or 527 of the Federal Food, Drug, and Cosmetic Act; orCommentsClose CommentsPermalink
‘(II) a single source drug (as described in subsection (c)(6)(D)(ii)) for which there is no period of exclusivity in effect or available under section 505(c), 505A, or 527 of the Federal Food, Drug, and Cosmetic Act.CommentsClose CommentsPermalink
‘(ii) STERILE INJECTABLE DRUG DEFINED- In this paragraph, the term ‘sterile injectable drug’ means a drug approved by the Food & Drug Administration that is injected into the body.CommentsClose CommentsPermalink
‘(C) USE OF VOLUME-WEIGHTED AVERAGE WHOLESALE ACQUISITION COSTS FOR MULTIPLE SOURCE DRUGS- The volume-weighted average wholesale acquisition costs under this paragraph shall be determined under this subparagraph in the same manner as the volume-weighted average of the average sales prices is determined under paragraph (6) except that, for purposes of this paragraph, any reference in such paragraph (6) to the average sale prices for a drug is deemed a reference to wholesale acquisition cost (as defined in subsection (c)(6)(B)) for the drug.’.CommentsClose CommentsPermalink
‘(I) STERILE INJECTABLE PRODUCTS WITH 3 OR FEWER ACTIVE MANUFACTURERS- The amount of payment for a drug described in section 1847A(b)(9)(B) that is furnished on or after July 1, 2013, and before January 1, 2020, shall be equal to--CommentsClose CommentsPermalink
‘(i) in the case of a drug described in clause (i) of such section, the volume-weighted wholesale acquisition costs amount determined under section 1847A(b)(9)(C) for the drug; andCommentsClose CommentsPermalink
‘(A) IN GENERAL- Paragraph (1) of this subsection and section 1903(i)(10)(A) shall not apply to a drug that is described in section 1847A(b)(9)(C), that is furnished on or after July 1, 2013, and before January 1, 2020, and for which payment may be made under part B of title XVIII.CommentsClose CommentsPermalink
(2) CONFORMING AMENDMENT- Section 1903(i)(10)(A) of the Social Security Act (
‘(1) IN GENERAL- For purposes of this section (including with respect to the prohibition described in subsection (a)(5)(L)(iii)), the term ‘covered outpatient drug’ shall not include a drug that is described in section 1847A(b)(9)(C) of the Social Security Act, that is furnished on or after July 1, 2013, and before January 1, 2020, and for which payment may be made under part B of title XVIII of such Act.CommentsClose CommentsPermalink
(1) IN GENERAL- The Secretary of Health and Human Services shall contract with an independent entity to study the effects of the amendments made by this section on patient access to sterile injectable products.CommentsClose CommentsPermalink
(2) REPORT- As a condition of the contract described under paragraph (1), the independent entity shall agree to submit to Congress and such Secretary, not later than 3 years after the date of enactment of this Act, a report that describes the results of the study conducted under paragraph (1).CommentsClose CommentsPermalink
SEC. 3. EXCLUSION OF BRANDED PRESCRIPTION DRUGS FROM ANNUAL FEE DURING PERIODS OF SHORTAGE.
(a) In General- Subsection (e) of section 9008 of the Patient Protection and Affordable Care Act is amended by redesignating paragraph (4) as paragraph (5) and by inserting after paragraph (3) the following new paragraph:CommentsClose CommentsPermalink
‘(B)(i) is the listed drug (as defined in section 505(j)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 355(j)(2)(A)(i)) for a drug for which the approval of an application under section 505(j) of such Act ( 21 U.S.C. 355(j)) is in effect, orCommentsClose CommentsPermalink
‘(ii) is the reference product (as defined in section 351(i) of the Public Health Service Act (
42 U.S.C. 262(i)) for a biological product for which the approval of an application under section 351(k) of such Act ( 42 U.S.C. 262(j)) is in effect.’.CommentsClose CommentsPermalink
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