To address critical drug shortages.

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.''.

Summary: 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.