[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2245 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2245

 To amend the Federal Food, Drug, and Cosmetic Act to provide the Food 
    and Drug Administration with improved capacity to prevent drug 
                               shortages.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 21, 2011

Ms. DeGette (for herself and Mr. Rooney) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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 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) Notifications by Manufacturers.--
            ``(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.
            ``(2) Notification period.--A notification pursuant to 
        paragraph (1) shall be submitted to the Secretary--
                    ``(A) in the case of a planned discontinuance, at 
                least 6 months prior to the date of such 
                discontinuance; and
                    ``(B) in the case of any other discontinuance or 
                interruption--
                            ``(i) at least 6 months prior to the date 
                        of such discontinuance or interruption; or
                            ``(ii) if the manufacturer cannot provide 6 
                        months advance notice, as soon as practicable 
                        after the manufacturer--
                                    ``(I) becomes aware of such 
                                discontinuance; or
                                    ``(II) becomes aware that such 
                                interruption may result in the total 
                                supply of the drug manufactured by the 
                                individual manufacturer not meeting 
                                average historic demand.
            ``(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.
            ``(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--
                    ``(A) a public health problem may result from 
                continuation of the manufacturing for the 6-month 
                period;
                    ``(B) a biomaterials shortage prevents the 
                continuation of the manufacturing for the 6-month 
                period;
                    ``(C) a liability problem may exist for the 
                manufacturer if the manufacturing is continued for the 
                6-month period;
                    ``(D) continuation of the manufacturing for the 6-
                month period may cause substantial economic hardship 
                for the manufacturer;
                    ``(E) the manufacturer has filed for bankruptcy 
                under chapter 7 or 11 of title 11, United States Code; 
                or
                    ``(F) the manufacturer can continue the 
                distribution of the drug involved for 6 months.
            ``(5) Other reductions in notification period.--The 
        Secretary may reduce the notification period required under 
        paragraph (2) based on--
                    ``(A) the type of discontinuance or interruption at 
                issue; and
                    ``(B) any other factor, as determined by the 
                Secretary.
            ``(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.
            ``(7) Enforcement.--
                    ``(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.
                    ``(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).
                    ``(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).
    ``(c) Notifications by Secretary.--
            ``(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.
            ``(2) Public notification.--
                    ``(A) In general.--Subject to subsection (b)(6), 
                the Secretary shall--
                            ``(i) publish on the public Internet Web 
                        site of the Food and Drug Administration 
                        information on--
                                    ``(I) the types of discontinuances 
                                and interruptions for which a 
                                notification is required under 
                                subsection (b)(1); and
                                    ``(II) actual drug shortages; and
                            ``(ii) to the maximum extent practicable, 
                        distribute such information to appropriate 
                        health care providers and patient 
                        organizations.
                    ``(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.
            ``(3) Identification and notification of drugs vulnerable 
        to drug shortage.--
                    ``(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--
                            ``(i) such determination; and
                            ``(ii) the Secretary's duty to collaborate 
                        to improve continuity of supply plans under 
                        paragraph (4).
                    ``(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--
                            ``(i) the number of manufacturers of the 
                        drug;
                            ``(ii) the sources of raw material or 
                        active pharmaceutical ingredients;
                            ``(iii) the supply chain characteristics, 
                        such as production complexities; and
                            ``(iv) the availability of therapeutic 
                        alternatives.
            ``(4) Continuity of supply plans.--
                    ``(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.
                    ``(B) Limitation on secretary's authority.--The 
                Secretary may not in any case require a manufacturer--
                            ``(i) to manufacture a drug in the event of 
                        a discontinuance or interruption; or
                            ``(ii) to delay or alter a discontinuance 
                        or interruption.
                    ``(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.
    ``(d) Rulemaking.--The Secretary shall carry out this section 
pursuant to regulations promulgated after providing notice and an 
opportunity for comment.''.
    (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.

SEC. 3. REPORTS TO CONGRESS.

    The Secretary of Health and Human Services shall submit to the 
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; and
            (2) every 5 years thereafter, a report describing such 
        actions taken by the Secretary during the previous 5-year 
        period.

SEC. 4. GAO STUDY.

    (a) Study.--The Comptroller General of the United States shall 
conduct a 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);
            (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;
            (3) to identify if there is adequate communication between 
        industry, the Food and Drug Administration, distributors, and 
        end users;
            (4) to analyze the effects of the enactment of this Act on 
        the ability of the Food and Drug Administration to identify and 
        ameliorate such drug shortages; and
            (5) to identify any additional measures that need to be 
        taken to prevent or address such drug shortages.
    (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).
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