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 of 2011''.
SEC. 2. DISCONTINUANCE OR INTERRUPTION OF THE MANUFACTURE OF A PRESCRIPTION DRUG.
(a) In General.--Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amended to read as follows:
``SEC. 506C. DISCONTINUANCE OR INTERRUPTION OF THE MANUFACTURE OF A PRESCRIPTION DRUG.
``(a) Definitions.--In this section: ``(1) The term `average historic demand' means the individual manufacturer's average monthly volume of sales of the drug during the last calendar year. ``(2) The term `discontinuance' means the permanent termination of the manufacture of a drug by an individual manufacturer. ``(3) The term `interruption' means a change that-- ``(A) may result in the total supply of a drug manufactured by the individual manufacturer not meeting average historic demand; and ``(B) consists of-- ``(i) a change in the supply of one or more raw materials, including active pharmaceutical ingredients; ``(ii) an unplanned interruption in ability to produce the drug; ``(iii) a business decision affecting the manufacture of the drug, such as a merger or a change in production output; or ``(iv) any other type change that could have the result described in subparagraph (A), as determined by the Secretary. ``(b)...