I 

112TH CONGRESS 

2D SESSION H. R. 3839 

To address critical drug shortages. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 31, 2012 

Mr. CARNEY (for himself and Mr. BUCSHON) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To address critical drug shortages. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Drug Shortage Preven5 tion Act of 2012’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 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. 


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1 SEC. 3. ACTIONS BY FOOD AND DRUG ADMINISTRATION TO 

2 ADDRESS CRITICAL DRUG SHORTAGES. 

3 Chapter V of the Federal Food, Drug, and Cosmetic 

4 Act is amended by inserting after section 506C (21 U.S.C. 

5 356c) the following: 

6 ‘‘SEC. 506D. ADDRESSING CRITICAL DRUG SHORTAGES. 

7 ‘‘(a) DEFINITIONS.—In this section: 

8 ‘‘(1) The term ‘biological product’ has the 

9 meaning given to such term in section 351(i) of the 

10 Public Health Service Act. 

11 ‘‘(2) The term ‘critical drug’ has the meaning 

12 given to such term by the Secretary pursuant to 

13 subsection (b)(2). 

14 ‘‘(3) The term ‘critical drug shortage’ has the 

15 meaning given to such term by the Secretary pursu16 ant to subsection (c)(2). 

17 ‘‘(4) The term ‘relevant stakeholders’ in18 cludes— 

19 ‘‘(A) with respect to drugs and biological 

20 products, manufacturers, distributors, and 

21 group purchasing organizations; and 

22 ‘‘(B) health care providers. 

23 ‘‘(b) NATIONAL CRITICAL DRUG LIST.— 

24 ‘‘(1) LIST.—The Secretary shall— 


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1 ‘‘(A) not later than 180 days after the date 

2 of the enactment of this section, establish a list 

3 identifying each critical drug; 

4 ‘‘(B) promptly remove any drug or biologi5 cal product from such list if the drug or biologi6 cal product no longer meets the definition of a 

7 critical drug established pursuant to paragraph 

8 (2); 

9 ‘‘(C) consider for inclusion in such list— 

10 ‘‘(i) each drug and biological product 

11 that is— 

12 ‘‘(I) approved or licensed under 

13 section 505 of this Act or section 351 

14 of the Public Health Service Act; or 

15 ‘‘(II) otherwise marketed pursu16 ant to regulation by the Food and 

17 Drug Administration; and 

18 ‘‘(ii) each such drug or biological 

19 product for which a new indication is ap20 proved; 

21 ‘‘(D) include in such list, with respect to 

22 each listed critical drug, information concerning 

23 the number and identity of the manufacturers 

24 of such drug; 

25 ‘‘(E) make such list publicly available; and 


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1 ‘‘(F) review and update such list semi2 annually. 

3 ‘‘(2) DEFINITION.—Not later than 90 days 

4 after the date of the enactment of this section, the 

5 Secretary shall define the term ‘critical drug’ for 

6 purposes of this section. In defining such term, the 

7 Secretary shall— 

8 ‘‘(A) solicit input from relevant stake9 holders through a public hearing or an oppor10 tunity to provide written comments; 

11 ‘‘(B) take into account the medical neces12 sity of a drug or biological product and exclude 

13 any drug or biological product that is not medi14 cally necessary; and 

15 ‘‘(C) take into account the vulnerability of 

16 a drug or biological product to shortage, includ17 ing because of the number of manufacturers 

18 and sources of active ingredients involved. 

19 ‘‘(3) REQUEST FOR REMOVAL.— 

20 ‘‘(A) IN GENERAL.—The manufacturer of 

21 a drug or biological product on the list estab22 lished under paragraph (1) may request that 

23 the Secretary remove the drug or biological 

24 product from the list on the basis that the drug 


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1 or biological product does not satisfy the defini2 tion of a critical drug. 

3 ‘‘(B) ACTION BY THE SECRETARY.—Not 

4 later than 45 days after receipt of such a re5 quest, the Secretary shall review the determina6 tion that the drug or biological product is a 

7 critical drug and— 

8 ‘‘(i) remove the drug or biological 

9 product from the list established under 

10 paragraph (1) if the Secretary determines 

11 that the drug is not a critical drug; or 

12 ‘‘(ii) provide to the manufacturer sub13 mitting such request an explanation of why 

14 the drug or biological product was properly 

15 determined to be a critical drug. 

16 ‘‘(c) NATIONAL CRITICAL DRUG SHORTAGE LIST.— 

17 ‘‘(1) LIST.—The Secretary shall— 

18 ‘‘(A) not later than 1 year after the date 

19 of the enactment of this section, establish and 

20 make publicly available a list identifying each 

21 critical drug that is in a critical drug shortage; 

22 and 

23 ‘‘(B) not less than monthly, review and, as 

24 appropriate, update such list. 


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1 ‘‘(2) DEFINITION.—Not later than 180 days 

2 after the date of the enactment of this section, the 

3 Secretary shall define the term ‘critical drug short4 age’ for purposes of this section. In defining such 

5 term, the Secretary shall— 

6 ‘‘(A) solicit input from relevant stake7 holders through a public hearing or an oppor8 tunity to provide written comments; and 

9 ‘‘(B) limit the definition to actual short10 ages in the United States of critical drugs. 

11 ‘‘(3) CONTENTS.—The list established under 

12 paragraph (1) shall, with respect to each listed crit13 ical drug shortage, include at a minimum access to 

14 the following information: 

15 ‘‘(A) Indication of the severity of the 

16 shortage. 

17 ‘‘(B) Each reason for the shortage. 

18 ‘‘(C) An estimated date by which the crit19 ical drug involved will begin reaching providers 

20 in quantities sufficient to meet demand. 

21 ‘‘(D) Identification of alternate therapies. 

22 ‘‘(E) Identification of specific regions of 

23 the country particularly affected or specifically 

24 not affected by the shortage. 

25 ‘‘(4) REQUEST FOR REMOVAL.— 


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1 ‘‘(A) IN GENERAL.—The manufacturer of 

2 a critical drug included on the list established 

3 under paragraph (1) may request that the Sec4 retary remove the critical drug from the list on 

5 the basis that the drug is not in a critical drug 

6 shortage. 

7 ‘‘(B) ACTION BY THE SECRETARY.—Not 

8 later than 45 days after receipt of such a re9 quest, the Secretary shall review the determina10 tion that a critical drug shortage exists and— 

11 ‘‘(i) remove the critical drug from the 

12 list if the Secretary determines that the 

13 drug is not in a critical drug shortage; or 

14 ‘‘(ii) provide to the manufacturer sub15 mitting such request an explanation of why 

16 the critical drug was properly determined 

17 to be in a critical drug shortage. 

18 ‘‘(d) SUPPLY CHAIN COMMUNICATION INFRASTRUC19 TURE.— 

20 ‘‘(1) NOTIFICATIONS TO PUBLIC.— 

21 ‘‘(A) IN GENERAL.—The Secretary shall 

22 establish and implement a proactive system for 

23 giving notice to the public concerning additions 

24 and other modifications to the list under sub25 section (c)(1) regarding critical drug shortages. 


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1 ‘‘(B) SYSTEM REQUIREMENTS.—The sys2 tem under subparagraph (A) shall provide such 

3 notices— 

4 ‘‘(i) to any member of the public on 

5 an opt-in basis; and 

6 ‘‘(ii) in written form comprehensible 

7 to a lay reader. 

8 ‘‘(C) INITIAL IMPLEMENTATION.—The 

9 Secretary shall begin implementation of the sys10 tem under subparagraph (A) not later than 1 

11 year after the date of the enactment of this sec12 tion. 

13 ‘‘(2) NOTIFICATIONS TO MANUFACTURERS AND

14 DISTRIBUTORS.— 

15 ‘‘(A) IN GENERAL.—The Secretary shall 

16 establish and implement a system for giving no17 tice of any imminent critical drug shortage to— 

18 ‘‘(i) any manufacturer of the critical 

19 drug registered under section 510; 

20 ‘‘(ii) any manufacturer so registered 

21 with capacity to manufacture the critical 

22 drug or an alternate therapy to the critical 

23 drug; and 

24 ‘‘(iii) subject to subparagraph (B) and 

25 at the Secretary’s discretion, any wholesale 


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1 distributor of the critical drug that has a 

2 contractual relationship with— 

3 ‘‘(I) the manufacturer of the crit4 ical drug; or 

5 ‘‘(II) an authorized distributor of 

6 record (as such term is defined in sec7 tion 503(e)(3)) of the critical drug. 

8 ‘‘(B) WHOLESALE DISTRIBUTORS PARTICI9 PATING IN UNLAWFUL ACTIVITIES.—If the At10 torney General determines that a wholesale dis11 tributor of a critical drug is participating in 

12 stockpiling, price gouging, or other unlawful ac13 tivities related to the distribution of a critical 

14 drug, the Secretary shall withhold any notifica15 tion that would otherwise be made to the dis16 tributor under subparagraph (A) with respect 

17 to the critical drug until the Attorney General 

18 determines that the distributor is no longer par19 ticipating in such activities. 

20 ‘‘(C) INITIAL IMPLEMENTATION.—The 

21 Secretary shall begin implementation of the sys22 tem under subparagraph (A) not later than 180 

23 days after the date of the enactment of this sec24 tion. 


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1 ‘‘(3) NOTIFICATIONS TO ATTORNEY GEN2 ERAL.—The Secretary shall— 

3 ‘‘(A) give notice to the Attorney General of 

4 any critical drug shortage listed under sub5 section (c); and 

6 ‘‘(B) provide such information to the At7 torney General as may be necessary to deter8 mine the extent to which it is appropriate to in9 crease one or more production quotas under 

10 section 306(h) of the Controlled Substances Act 

11 in order to address such shortage. 

12 ‘‘(e) STUDY ON FEASIBILITY OF NATIONAL CONTIN13 GENCY PLAN.— 

14 ‘‘(1) STUDY.—The Secretary shall conduct a 

15 study on the feasibility of creating a national contin16 gency plan addressing critical drug shortages, in17 cluding with respect to— 

18 ‘‘(A) the creation of a Federal stockpile of 

19 critical drugs for the purpose of responding to 

20 potential critical drug shortages; or 

21 ‘‘(B) the expansion of an existing Federal 

22 stockpile of drugs to include critical drugs for 

23 such purpose. 


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1 ‘‘(2) CONSULTATION.—In conducting the study 

2 under paragraph (1), the Secretary shall consult 

3 with relevant stakeholders. 

4 ‘‘(3) REPORT.—Not later than 1 year after the 

5 date of the enactment of this Act, the Secretary 

6 shall complete the study required by paragraph (1) 

7 and submit to the Congress a report on the results 

8 of such study. 

9 ‘‘(f) APPROVAL OF DRUGS.— 

10 ‘‘(1) EXPEDITED REVIEW.—The Secretary shall 

11 expedite the review of— 

12 ‘‘(A) any application seeking approval of a 

13 critical drug under subsection (c) or (j) of sec14 tion 505 of this Act or licensing of a critical 

15 drug under section 351 of the Public Health 

16 Service Act; and 

17 ‘‘(B) any request by the sponsor of a crit18 ical drug to approve— 

19 ‘‘(i) a change to the manufacturing 

20 process for a critical drug, including any 

21 change in the facilities used for such proc22 ess; or 

23 ‘‘(ii) an alternate supplier of any ac24 tive ingredient in a critical drug. 


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1 ‘‘(2) NO DELAY OF OTHER APPLICATIONS.—In 

2 expediting the review of applications and requests 

3 under paragraph (1), the Secretary shall not unnec4 essarily delay the review of applications and requests 

5 for drugs and biological products that are not crit6 ical drugs. 

7 ‘‘(3) ESTABLISHMENT OF PROCEDURES AND

8 TIMEFRAMES.—Not later than 90 days after the 

9 date of the enactment of this section, the Secretary, 

10 with input from relevant stakeholders, shall establish 

11 procedures and timeframes for providing expedited 

12 review under paragraph (1). 

13 ‘‘(g) IMPROVED REGULATION.—The Secretary shall 

14 review and improve the process for regulating critical 

15 drugs so as to— 

16 ‘‘(1) ensure that, at each stage of such process, 

17 the status of such drugs as critical drugs is taken 

18 into consideration; 

19 ‘‘(2) improve communications between the of20 fices and officials of the Food and Drug Administra21 tion responsible for approving and regulating critical 

22 drugs and the offices and officials of the Food and 

23 Drug Administration responsible for identifying and 

24 addressing critical drug shortages; and 


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1 ‘‘(3) ensure that any new regulatory concern 

2 about a critical drug identified by Food and Drug 

3 Administration personnel is communicated— 

4 ‘‘(A) within 1 business day to the office of 

5 the Food and Drug Administration responsible 

6 for identifying and addressing critical drug 

7 shortages; and 

8 ‘‘(B) within 5 business days to the manu9 facturer of the critical drug. 

10 ‘‘(h) CONFIDENTIALITY.— 

11 ‘‘(1) IN GENERAL.—Except as described in 

12 paragraph (2), in carrying out this section, the Sec13 retary shall not disclose— 

14 ‘‘(A) any trade secret or other matter that 

15 is referred to in section 1905 of title 18 of the 

16 United States Code, or 

17 ‘‘(B) any trade secret or other commercial 

18 or financial information that is exempt from 

19 disclosure under section 552(b)(4) of title 5 of 

20 the United States Code. 

21 ‘‘(2) DISCLOSURE TO FEDERAL OFFICERS AND

22 EMPLOYEES.—The Secretary may disclose such mat23 ter or information to an officer or employee of the 

24 Federal Government, but only if— 


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1 ‘‘(A) such disclosure is for the purpose of 

2 carrying out this section or section 306(h) of 

3 the Controlled Substances Act; and 

4 ‘‘(B) any further disclosure of such matter 

5 or information by the officer and employee is 

6 restricted to the same extent as disclosure of 

7 such matter or information by the Secretary. 

8 ‘‘(i) SENSE OF CONGRESS REGARDING INCREASE IN

9 PERSONNEL.—It is the sense of the Congress that the 

10 Food and Drug Administration should increase the num11 ber of personnel responsible for identifying and addressing 

12 critical drug shortages.’’. 

13 SEC. 4. ACTIONS BY ATTORNEY GENERAL TO ADDRESS 

14 CRITICAL DRUG SHORTAGES. 

15 Section 306 of the Controlled Substances Act (21 

16 U.S.C. 826) is amended by adding at the end the fol17 lowing: 

18 ‘‘(h) If the Secretary of Health and Human Services 

19 lists a critical drug shortage under section 506D(c) of the 

20 Federal Food, Drug, and Cosmetic Act, and the drug in21 volved or any ingredient therein is a controlled substance 

22 subject to a quota under this section, then the Attorney 

23 General shall increase such quota to the extent determined 

24 by the Attorney General, in consultation with the SecVerDate Mar 15 2010 03:57 Feb 01, 2012 Jkt 019200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H3839.IH H3839

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1 retary of Health and Human Services, to be appropriate 

2 to address the critical drug shortage.’’. 

Æ 


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