S.296 - Preserving Access to Life-Saving Medications Act
A bill 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. DRUG SHORTAGES.
(a) Expansion of Notification Requirement Regarding Potential Shortages of Prescription Drugs- Section 506C of the Federal Food, Drug, and Cosmetic Act (
(1) in the section heading, by striking ‘discontinuance of a life saving product’ and inserting ‘discontinuance or interruption of the manufacture of a prescription drug’; andCommentsClose CommentsPermalink
‘(1) DEFINITION- In this section, the terms ‘drug shortage’ and ‘shortage’, when used with respect to a drug, mean a period of time when the total supply of all versions of a drug available at the user level will not meet the current demand for the drug at the user level.CommentsClose CommentsPermalink
‘(2) NOTIFICATION- A manufacturer of a drug described in paragraph (3) shall notify the Secretary of a discontinuance, interruption, or other adjustment of the manufacture of the drug that would likely result in a shortage of such drug--CommentsClose CommentsPermalink
‘(A) in the case of a discontinuance or planned interruption or adjustment, at least 6 months prior to the date of such discontinuance or planned interruption or adjustment; andCommentsClose CommentsPermalink
‘(6) ENFORCEMENT- Not later than 180 days after the date of enactment of this section, the Secretary shall promulgate regulations establishing a schedule of civil monetary penalties for failure to submit a notification as required under this subsection.’.CommentsClose CommentsPermalink
‘(1) NOTIFICATION OF SHORTAGES- The Secretary shall publish information on the types of adjustments for which a notification is required under subsection (a)(4) and on actual drug shortages on the Internet Web site of the Food and Drug Administration and, to the maximum extent practicable, distribute such information to appropriate health care provider and patient organizations.CommentsClose CommentsPermalink
‘(A) IN GENERAL- 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
‘(B) NOTIFICATION- If the Secretary determines using the criteria under subparagraph (A) that a drug may be vulnerable to a drug shortage, the Secretary shall notify the manufacturer of the drug of such determination and of the collaboration described under paragraph (3).CommentsClose CommentsPermalink
‘(3) CONTINUITY OF OPERATIONS PLANS- The Secretary shall collaborate with manufacturers of drugs identified pursuant to paragraph (2) to establish and improve continuity of operations plans with respect to medically necessary drugs, as defined by the Secretary, so that such plans include a process for addressing drug shortages.’.CommentsClose CommentsPermalink
SEC. 3. MANUFACTURER REVIEW.
‘(2)(A) If an establishment registered with the Secretary pursuant to this section is subject to a reinspection due to failure to comply with a requirement of this Act, the Secretary shall conduct such reinspection not later than 90 days after the establishment certifies to the Secretary that the establishment has corrected the reason for such failure.CommentsClose CommentsPermalink
‘(B) The Secretary shall prioritize reinspections described in subparagraph (A) based on whether the establishment involved manufactures, propagates, compounds, or processes a drug involved in a drug shortage (as defined in section 506C).’.CommentsClose CommentsPermalink
SEC. 4. REPORTS TO CONGRESS.
Not later than 1 year after the date of enactment of this Act, and on an annual basis thereafter, the Secretary of Health and Human Services shall submit to Congress a report that describes the actions taken by such Secretary during the previous 1-year period to address drug shortages through all aspects of the prescription drug supply chain.CommentsClose CommentsPermalink