Q: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
SECTION 1. SHORT TITLE.

This Act may be cited as the ''Drug Shortage Prevention Act of
2012''.

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Actions by Food and Drug Administration To Address Critical
Drug Shortages.
Sec. 4. Actions by Attorney General To Address Critical Drug Shortages.

SEC. 3. ACTIONS BY FOOD AND DRUG ADMINISTRATION TO ADDRESS CRITICAL
DRUG SHORTAGES.

Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 506C (21 U.S.C. 356c) the following:

''SEC. 506D. ADDRESSING CRITICAL DRUG SHORTAGES.

''(a) Definitions.--In this section:
''(1) The term 'biological product' has the meaning given
to such term in section 351(i) of the Public Health Service
Act.
''(2) The term 'critical drug' has the meaning given to
such term by the Secretary pursuant to subsection (b)(2).
''(3) The term 'critical drug shortage' has the meaning
given to such term by the Secretary pursuant to subsection
(c)(2).
''(4) The term 'relevant stakeholders' includes--
''(A) with respect to drugs and biological
products, manufacturers, distributors, and group
purchasing organizations; and
''(B) health care providers.
''(b) National Critical Drug List.--
''(1) List.--The Secretary shall--
''(A) not later than 180 days after the date of the
enactment of this section, establish a list identifying
each critical drug;
''(B) promptly remove any drug or biological
product from such list if the drug or biological
product no longer meets the definition of a critical
drug established pursuant to paragraph (2);
''(C) consider for inclusion in such list--
''(i) each drug and biological product that
is--
''(I) approved or licensed under
section 505 of this Act or section 351
of the Public Health Service Act; or
''(II) otherwise marketed pursuant
to regulation by the Food and Drug
Administration; and
''(ii) each such drug or biological product
for which a new indication is approved;
''(D) include in such list, with respect to each
listed critical drug, information concerning the number
and identity of the manufacturers of such drug;
''(E) make such list publicly available; and
''(F) review and update such list semiannually.
''(2) Definition.--Not later than 90 days after the date of
the enactment of this section, the Secretary shall define the
term 'critical drug' for purposes of this section. In defining
such term, the Secretary shall--
''(A) solicit input from relevant stakeholders
through a public hearing or an opportunity to provide
written comments;
''(B) take into account the medical necessity of a
drug or biological product and exclude any drug or
biological product that is not medically necessary; and
''(C) take into account the vulnerability of a drug
or biological product to shortage, including because of
the number of manufacturers and sources of active
ingredients involved.
''(3) Request for removal.--
''(A) In general.--The manufacturer of a drug or
biological product on the list established under
paragraph (1) may request that the Secretary remove the
drug or biological product from the list on the basis
that the drug or biological product does not satisfy
the definition of a critical drug.
''(B) Action by the secretary.--Not later than 45
days after receipt of such a request, the Secretary
shall review the determination that the drug or
biological product is a critical drug and--
''(i) remove the drug or biological product
from the list established under paragraph (1)
if the Secretary determines that the drug is
not a critical drug; or
''(ii) provide to the manufacturer
submitting such request an explanation of why
the drug or biological product was properly
determined to be a critical drug.
''(c) National Critical Drug Shortage List.--
''(1) List.--The Secretary shall--
''(A) not later than 1 year after the date of the
enactment of this section, establish and make publicly
available a list identifying each critical drug that is
in a critical drug shortage; and
''(B) not less than monthly, review and, as
appropriate, update such list.
''(2) Definition.--Not later than 180 days after the date
of the enactment of this section, the Secretary shall define
the term 'critical drug shortage' for purposes of this section.
In defining such term, the Secretary shall--
''(A) solicit input from relevant stakeholders
through a public hearing or an opportunity to provide
written comments; and
''(B) limit the definition to actual shortages in
the United States of critical drugs.
''(3) Contents.--The list established under paragraph (1)
shall, with respect to each listed critical drug shortage,
include at a minimum access to the following information:
''(A) Indication of the severity of the shortage.
''(B) Each reason for the shortage.
''(C) An estimated date by which the critical drug
involved will begin reaching providers in quantities
sufficient to meet demand.
''(D) Identification of alternate therapies.
''(E) Identification of specific regions of the
country particularly affected or specifically not
affected by the shortage.
''(4) Request for removal.--
''(A) In general.--The manufacturer of a critical
drug included on the list established under paragraph
(1) may request that the Secretary remove the critical
drug from the list on the basis that the drug is not in
a critical drug shortage.
''(B) Action by the secretary.--Not later than 45
days after receipt of such a request, the Secretary
shall review the determination that a critical drug
shortage exists and--
''(i) remove the critical drug from the
list if the Secretary determines that the drug
is not in a critical drug shortage; or
''(ii) provide to the manufacturer
submitting such request an explanation of why
the critical drug was properly determined to be
in a critical drug shortage.
''(d) Supply Chain Communication Infrastructure.--
''(1) Notifications to public.--
''(A) In general.--The Secretary shall establish
and implement a proactive system for giving notice to
the public concerning additions and other modifications
to the list under subsection (c)(1) regarding critical
drug shortages.
''(B) System requirements.--The system under
subparagraph (A) shall provide such notices--
''(i) to any member of the public on an
opt-in basis; and
''(ii) in written form comprehensible to a
lay reader.
''(C) Initial implementation.--The Secretary shall
begin implementation of the system under subparagraph
(A) not later than 1 year after the date of the
enactment of this section.
''(2) Notifications to manufacturers and distributors.--
''(A) In general.--The Secretary shall establish
and implement a system for giving notice of any
imminent critical drug shortage to--
''(i) any manufacturer of the critical drug
registered under section 510;
''(ii) any manufacturer so registered with
capacity to manufacture the critical drug or an
alternate therapy to the critical drug; and
''(iii) subject to subparagraph (B) and at
the Secretary's discretion, any wholesale
distributor of the critical drug that has a
contractual relationship with--
''(I) the manufacturer of the
critical drug; or
''(II) an authorized distributor of
record (as such term is defined in
section 503(e)(3)) of the critical
drug.
''(B) Wholesale distributors participating in
unlawful activities.--If the Attorney General
determines that a wholesale distributor of a critical
drug is participating in stockpiling, price gouging, or
other unlawful activities related to the distribution
of a critical drug, the Secretary shall withhold any
notification that would otherwise be made to the
distributor under subparagraph (A) with respect to the
critical drug until the Attorney General determines
that the distributor is no longer participating in such
activities.
''(C) Initial implementation.--The Secretary shall
begin implementation of the system under subparagraph
(A) not later than 180 days after the date of the
enactment of this section.
''(3) Notifications to attorney general.--The Secretary
shall--
''(A) give notice to the Attorney General of any
critical drug shortage listed under subsection (c); and
''(B) provide such information to the Attorney
General as may be necessary to determine the extent to
which it is appropriate to increase one or more
production quotas under section 306(h) of the
Controlled Substances Act in order to address such
shortage.
''(e) Study on Feasibility of National Contingency Plan.--
''(1) Study.--The Secretary shall conduct a study on the
feasibility of creating a national contingency plan addressing
critical drug shortages, including with respect to--
''(A) the creation of a Federal stockpile of
critical drugs for the purpose of responding to
potential critical drug shortages; or
''(B) the expansion of an existing Federal
stockpile of drugs to include critical drugs for such
purpose.
''(2) Consultation.--In conducting the study under
paragraph (1), the Secretary shall consult with relevant
stakeholders.
''(3) Report.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall complete the study
required by paragraph (1) and submit to the Congress a report
on the results of such study.
''(f) Approval of Drugs.--
''(1) Expedited review.--The Secretary shall expedite the
review of--
''(A) any application seeking approval of a
critical drug under subsection (c) or (j) of section
505 of this Act or licensing of a critical drug under
section 351 of the Public Health Service Act; and
''(B) any request by the sponsor of a critical drug
to approve--
''(i) a change to the manufacturing process
for a critical drug, including any change in
the facilities used for such process; or
''(ii) an alternate supplier of any active
ingredient in a critical drug.
''(2) No delay of other applications.--In expediting the
review of applications and requests under paragraph (1), the
Secretary shall not unnecessarily delay the review of
applications and requests for drugs and biological products
that are not critical drugs.
''(3) Establishment of procedures and timeframes.--Not
later than 90 days after the date of the enactment of this
section, the Secretary, with input from relevant stakeholders,
shall establish procedures and timeframes for providing
expedited review under paragraph (1).
''(g) Improved Regulation.--The Secretary shall review and improve
the process for regulating critical drugs so as to--
''(1) ensure that, at each stage of such process, the
status of such drugs as critical drugs is taken into
consideration;
''(2) improve communications between the offices and
officials of the Food and Drug Administration responsible for
approving and regulating critical drugs and the offices and
officials of the Food and Drug Administration responsible for
identifying and addressing critical drug shortages; and
''(3) ensure that any new regulatory concern about a
critical drug identified by Food and Drug Administration
personnel is communicated--
''(A) within 1 business day to the office of the
Food and Drug Administration responsible for
identifying and addressing critical drug shortages; and
''(B) within 5 business days to the manufacturer of
the critical drug.
''(h) Confidentiality.--
''(1) In general.--Except as described in paragraph (2), in
carrying out this section, the Secretary shall not disclose--
''(A) any trade secret or other matter that is
referred to in section 1905 of title 18 of the United
States Code, or
''(B) any trade secret or other commercial or
financial information that is exempt from disclosure
under section 552(b)(4) of title 5 of the United States
Code.
''(2) Disclosure to federal officers and employees.--The
Secretary may disclose such matter or information to an officer
or employee of the Federal Government, but only if--
''(A) such disclosure is for the purpose of
carrying out this section or section 306(h) of the
Controlled Substances Act; and
''(B) any further disclosure of such matter or
information by the officer and employee is restricted
to the same extent as disclosure of such matter or
information by the Secretary.
''(i) Sense of Congress Regarding Increase in Personnel.--It is the
sense of the Congress that the Food and Drug Administration should
increase the number of personnel responsible for identifying and
addressing critical drug shortages.''.

SEC. 4. ACTIONS BY ATTORNEY GENERAL TO ADDRESS CRITICAL DRUG SHORTAGES.

Section 306 of the Controlled Substances Act (21 U.S.C. 826) is
amended by adding at the end the following:
''(h) If the Secretary of Health and Human Services lists a
critical drug shortage under section 506D(c) of the Federal Food, Drug,
and Cosmetic Act, and the drug involved or any ingredient therein is a
controlled substance subject to a quota under this section, then the
Attorney General shall increase such quota to the extent determined by
the Attorney General, in consultation with the Secretary of Health and
Human Services, to be appropriate to address the critical drug
shortage.''.
A:
Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available, and update monthly a list identifying each critical drug that is in a critical drug shortage in the United States, the severity of and reason for the shortage, alternate therapies and regions particularly affected, and an estimated date by which the necessary quantities of the drug will begin reaching providers.

Allows manufacturers to request removal of a drug from such lists on the basis that it doesn't meet the definition of "critical drug" or is not in a critical drug shortage.

Directs the Secretary to: (1) establish a proactive system for giving notice to the public concerning modifications to the critical drug shortage list, (2) establish a system for giving notice of any imminent critical drug shortage to critical drug manufacturers and wholesale distributors and manufacturers of alternative therapies, (3) notify the Attorney General of any critical drug shortage, (4) study the feasibility of creating a national contingency plan addressing critical drug shortages, (5) expedite the review of applications for approval of critical drugs and requests by sponsors of such drugs to approve manufacturing process changes or alternate suppliers of active ingredients, and (6) improve the process for regulating critical drugs.

Express the sense of Congress that the Food and Drug Administration (FDA) should increase the number of personnel responsible for identifying and addressing critical drug shortages.

Amends the Controlled Substances Act to direct the Attorney General to increase a quota as appropriate for a drug listed in a critical drug shortage that is or contains a controlled substance.