Preserving Access to Life-Saving Medications Act - Amends the Federal Food, Drug, and Cosmetic Act to require a prescription drug manufacturer to notify the Secretary of Health and Human Services (HHS) of a discontinuance, interruption, or other adjustment of the manufacture of the drug that would likely result in a shortage of such drug. Requires: (1) six months notice of any discontinuance or planned interruption or adjustment, and (2) notice as soon as practicable after becoming aware of such interruption or adjustment in the case of any other interruption or adjustment. Applies this Act to any approved prescription drug that is not a product that was originally derived from human tissue and was replaced by a recombinant product.
Sets forth the types of adjustment for which a manufacturer must submit notice, including: (1) adjustments related to the supply of raw materials, (2) adjustments to production capabilities, (3) business decisions that may affect the manufacture of the drug, and (4) other adjustments as determined appropriate by the Secretary.
[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.
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Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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