Summary

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. Read More

Status

This bill was introduced on Feb 7, 2011, in a previous session of Congress, but was not passed.

Bill Text

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Preserving Access to Life-Saving Medications Act''.

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 (21 U.S.C. 356c) is amended-- (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''; and (2) by amending subsection (a) to read as follows: ``(a) In General.-- ``(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. ``(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-- ``(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; and ``(B) in the case of any other...

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Organizations Supporting

ASHP supports the Preserving Access to Life Saving Medications Act (S. 296) cosponsored by Sens. Klobuchar and Casey. Drug shortages in hospitals and health systems cause significant disruptions in patient care. The medications affected are often life saving drugs as well as medications used to relieve pain, to treat serious infections, and other conditions. http://www.ashp.org/congress

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Senate Bill 296 would provide the U.S. Food and Drug Administration (FDA) with tools to better manage and hopefully prevent shortages of life-saving medications. This legislation enables the FDA to work more effectively with the pharmaceutical supply chain to ensure drug availability, and enhances the agency's ability to monitor drugs that are vulnerable to shortages in the future. The legislation also enables FDA to work with drug manufacturers to establish contingency plans for manufacturing interruptions, such as raw material shortages, adjustments to production capabilities and product discontinuations. http://www.michiganpharmacists.org/advocacy/actionCenter/

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Bill Summary

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