H.R.2245 - Preserving Access to Life-Saving Medications Act of 2011
To amend the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration with improved capacity to prevent drug shortages.
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SECTION 1. SHORT TITLE.
SEC. 2. DISCONTINUANCE OR INTERRUPTION OF THE MANUFACTURE OF A PRESCRIPTION DRUG.
‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION OF THE MANUFACTURE OF A PRESCRIPTION DRUG.
‘(1) IN GENERAL- A manufacturer of a drug that is subject to section 503(b)(1) and marketed in interstate commerce shall notify the Secretary of a discontinuance or interruption in the manufacture of such drug.CommentsClose CommentsPermalink
‘(3) ADDITIONAL INFORMATION- A manufacturer may, but is not required to, include in a notification submitted pursuant to paragraph (1) information about an alternative source of the drug or the availability of a drug with the same active ingredient.CommentsClose CommentsPermalink
‘(4) REDUCTION IN NOTIFICATION PERIOD- The notification period required under paragraph (2) for a manufacturer may be reduced if the manufacturer certifies to the Secretary that good cause exists for the reduction, such as a situation in which--CommentsClose CommentsPermalink
‘(6) CONFIDENTIALITY OF INFORMATION- Any information provided to the Secretary under paragraph (1) shall be treated as trade secret or confidential information subject to section 552(b)(4) of title 5 and section 1905 of title 18.CommentsClose CommentsPermalink
‘(A) Any manufacturer that knowingly fails to submit a notification in violation of paragraph (1) shall be subject to a civil money penalty not to exceed $10,000 for each day on which the violation continues, and not to exceed $1,800,000 for all such violations adjudicated in a single proceeding.CommentsClose CommentsPermalink
‘(B) Not later than 180 days after the date of the enactment of the Preserving Access to Life-Saving Medications Act of 2011, the Secretary shall, subject to subparagraph (A), promulgate final regulations establishing a schedule of civil monetary penalties for violations of paragraph (1).CommentsClose CommentsPermalink
‘(C) The provisions of paragraphs (5), (6), and (7) of section 303(f) shall apply with respect to a civil penalty under this paragraph to the same extent and in the same manner as such provisions apply with respect to a civil penalty under paragraph (1), (2), (3), (4), or (9) of section 303(f).CommentsClose CommentsPermalink
‘(1) DRUG SHORTAGE DEFINED- In this section, the term ‘drug shortage’ means, with respect to a drug, a period of time when the total supply of such drug available at the user level will not meet the demand for such drug at the user level as determined by the Secretary.CommentsClose CommentsPermalink
‘(B) DURATION- The Secretary shall include in any publication or distribution under subparagraph (A), when possible, an estimate of the expected duration of any discontinuance or interruption or actual drug shortage.CommentsClose CommentsPermalink
‘(A) IN GENERAL- If the Secretary determines using the criteria under subparagraph (B) that a drug may be vulnerable to a drug shortage, the Secretary shall notify the manufacturer of the drug of--CommentsClose CommentsPermalink
‘(B) EVIDENCE-BASED CRITERIA- The Secretary shall implement evidence-based criteria for identifying drugs that may be vulnerable to a drug shortage. Such criteria shall be based on--CommentsClose CommentsPermalink
‘(A) IN GENERAL- With respect to drugs that are vulnerable to a drug shortage (as determined under paragraph (3)), the Secretary shall collaborate with manufacturers and other stakeholders (such as distributors and health care providers) to establish and improve continuity of supply plans, so that such plans include a process for addressing drug shortages.CommentsClose CommentsPermalink
‘(C) ALLOCATION BY MANUFACTURER- No provision of Federal law shall be construed to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution of its products in order to manage an actual or potential drug shortage.CommentsClose CommentsPermalink
(b) Applicability; Transitional Period- Section 506C of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a), applies with respect to discontinuances, interruptions, and drug shortages (as such terms are used in such section 506C) that occur on or after the day that is 1 year after the date of the enactment of this Act. Until such day, the provisions of section 506C of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the enactment of this Act, shall continue to apply.CommentsClose CommentsPermalink
SEC. 3. REPORTS TO CONGRESS.
(1) not later than the date that is 1 year after the date of the enactment of this Act, a report describing the actions taken by the Secretary during the previous 1-year period to address drug shortages (as defined in section 506C of the Federal Food, Drug, and Cosmetic Act, as amended by section 2) through all aspects of the prescription drug supply chain; andCommentsClose CommentsPermalink
SEC. 4. GAO STUDY.
(1) to examine how the Food and Drug Administration identifies and responds to drug shortages (as defined in section 506C of the Federal Food, Drug, and Cosmetic Act, as amended by section 2);CommentsClose CommentsPermalink
(2) to examine the possible causes of such drug shortages, including manufacturing problems, breakdown in the supply chain delivery system, changes in the supply of raw materials, stockpiling at the wholesale or provider level, and restrictive regulatory requirements;CommentsClose CommentsPermalink
(b) Report- Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall submit a report to the Congress on the results of the study under subsection (a).CommentsClose CommentsPermalink