```

[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 296 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                 S. 296

 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 SENATE OF THE UNITED STATES

                            February 7, 2011

  Ms. Klobuchar (for herself and Mr. Casey) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 interruption or 
                adjustment, as soon as practicable after becoming aware 
                of such interruption or adjustment.
            ``(3) Drugs described.--A drug described in this paragraph 
        is a drug--
                    ``(A) for which an application has been approved 
                under section 505(b) or 505(j);
                    ``(B) that is described in section 503(b)(1); and
                    ``(C) that is not a product that was originally 
                derived from human tissue and was replaced by a 
                recombinant product.
            ``(4) Types of adjustments.--An adjustment for which a 
        manufacturer shall submit a notification under paragraph (2) 
        includes--
                    ``(A) adjustments related to the supply of raw 
                materials, including active pharmaceutical ingredients;
                    ``(B) adjustments to production capabilities;
                    ``(C) business decisions that may affect the 
                manufacture of the drug, such as mergers, 
                discontinuations, and a change in production output; 
                and
                    ``(D) other adjustments as determined appropriate 
                by the Secretary.
            ``(5) Modification of time frames.--The Secretary may 
        adjust the required time frame under paragraph (2) as 
        determined appropriate by the Secretary based on--
                    ``(A) the type of interruption or adjustment at 
                issue; and
                    ``(B) any other factor, as determined by the 
                Secretary.
            ``(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.''.
    (b) Confidentiality of Information.--Section 506C(c) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 356c(c)) is amended to read as 
follows:
    ``(c) Confidentiality of Information.--The Secretary shall ensure 
the confidentiality of proprietary information submitted in a 
notification under subsection (a).''.
    (c) Public Notification.--Section 506C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356c) is amended by adding at the end the 
following:
    ``(d) Public Notification.--
            ``(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.
            ``(2) Identification and notification of drugs vulnerable 
        to drug shortage.--
                    ``(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--
                            ``(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.
                    ``(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).
            ``(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.''.

SEC. 3. MANUFACTURER REVIEW.

    Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(h)) is amended--
            (1) by striking ``(h)'' and inserting ``(h)(1)''; and
            (2) by inserting at the end the following:
    ``(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.
    ``(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).''.

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.
                                 <all>
```