I 

112TH CONGRESS 

1ST SESSION H. R. 2245 

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 HOUSE OF REPRESENTATIVES 

JUNE 21, 2011 

Ms. DEGETTE (for herself and Mr. ROONEY) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

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. 

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 ‘‘Preserving Access to 

5 Life-Saving Medications Act of 2011’’. 

6 SEC. 2. DISCONTINUANCE OR INTERRUPTION OF THE MAN7 UFACTURE OF A PRESCRIPTION DRUG. 

8 (a) IN GENERAL.—Section 506C of the Federal 

9 Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is amend10 ed to read as follows: 


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1 ‘‘SEC. 506C. DISCONTINUANCE OR INTERRUPTION OF THE 

2 MANUFACTURE OF A PRESCRIPTION DRUG. 

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

4 ‘‘(1) The term ‘average historic demand’ means 

5 the individual manufacturer’s average monthly vol6 ume of sales of the drug during the last calendar 

7 year. 

8 ‘‘(2) The term ‘discontinuance’ means the per9 manent termination of the manufacture of a drug by 

10 an individual manufacturer. 

11 ‘‘(3) The term ‘interruption’ means a change 

12 that— 

13 ‘‘(A) may result in the total supply of a 

14 drug manufactured by the individual manufac15 turer not meeting average historic demand; and 

16 ‘‘(B) consists of— 

17 ‘‘(i) a change in the supply of one or 

18 more raw materials, including active phar19 maceutical ingredients; 

20 ‘‘(ii) an unplanned interruption in 

21 ability to produce the drug; 

22 ‘‘(iii) a business decision affecting the 

23 manufacture of the drug, such as a merger 

24 or a change in production output; or 


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1 ‘‘(iv) any other type change that could 

2 have the result described in subparagraph 

3 (A), as determined by the Secretary. 

4 ‘‘(b) NOTIFICATIONS BY MANUFACTURERS.— 

5 ‘‘(1) IN GENERAL.—A manufacturer of a drug 

6 that is subject to section 503(b)(1) and marketed in 

7 interstate commerce shall notify the Secretary of a 

8 discontinuance or interruption in the manufacture of 

9 such drug. 

10 ‘‘(2) NOTIFICATION PERIOD.—A notification 

11 pursuant to paragraph (1) shall be submitted to the 

12 Secretary— 

13 ‘‘(A) in the case of a planned discontinu14 ance, at least 6 months prior to the date of 

15 such discontinuance; and 

16 ‘‘(B) in the case of any other discontinu17 ance or interruption— 

18 ‘‘(i) at least 6 months prior to the 

19 date of such discontinuance or interrup20 tion; or 

21 ‘‘(ii) if the manufacturer cannot pro22 vide 6 months advance notice, as soon as 

23 practicable after the manufacturer— 

24 ‘‘(I) becomes aware of such dis25 continuance; or 


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1 ‘‘(II) becomes aware that such 

2 interruption may result in the total 

3 supply of the drug manufactured by 

4 the individual manufacturer not meet5 ing average historic demand. 

6 ‘‘(3) ADDITIONAL INFORMATION.—A manufac7 turer may, but is not required to, include in a notifi8 cation submitted pursuant to paragraph (1) infor9 mation about an alternative source of the drug or 

10 the availability of a drug with the same active ingre11 dient. 

12 ‘‘(4) REDUCTION IN NOTIFICATION PERIOD.— 

13 The notification period required under paragraph 

14 (2) for a manufacturer may be reduced if the manu15 facturer certifies to the Secretary that good cause 

16 exists for the reduction, such as a situation in 

17 which— 

18 ‘‘(A) a public health problem may result 

19 from continuation of the manufacturing for the 

20 6-month period; 

21 ‘‘(B) a biomaterials shortage prevents the 

22 continuation of the manufacturing for the 6- 

23 month period; 


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1 ‘‘(C) a liability problem may exist for the 

2 manufacturer if the manufacturing is continued 

3 for the 6-month period; 

4 ‘‘(D) continuation of the manufacturing 

5 for the 6-month period may cause substantial 

6 economic hardship for the manufacturer; 

7 ‘‘(E) the manufacturer has filed for bank8 ruptcy under chapter 7 or 11 of title 11, United 

9 States Code; or 

10 ‘‘(F) the manufacturer can continue the 

11 distribution of the drug involved for 6 months. 

12 ‘‘(5) OTHER REDUCTIONS IN NOTIFICATION PE13 RIOD.—The Secretary may reduce the notification 

14 period required under paragraph (2) based on— 

15 ‘‘(A) the type of discontinuance or inter16 ruption at issue; and 

17 ‘‘(B) any other factor, as determined by 

18 the Secretary. 

19 ‘‘(6) CONFIDENTIALITY OF INFORMATION.— 

20 Any information provided to the Secretary under 

21 paragraph (1) shall be treated as trade secret or 

22 confidential information subject to section 552(b)(4) 

23 of title 5 and section 1905 of title 18. 

24 ‘‘(7) ENFORCEMENT.— 


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1 ‘‘(A) Any manufacturer that knowingly 

2 fails to submit a notification in violation of 

3 paragraph (1) shall be subject to a civil money 

4 penalty not to exceed $10,000 for each day on 

5 which the violation continues, and not to exceed 

6 $1,800,000 for all such violations adjudicated 

7 in a single proceeding. 

8 ‘‘(B) Not later than 180 days after the 

9 date of the enactment of the Preserving Access 

10 to Life-Saving Medications Act of 2011, the 

11 Secretary shall, subject to subparagraph (A), 

12 promulgate final regulations establishing a 

13 schedule of civil monetary penalties for viola14 tions of paragraph (1). 

15 ‘‘(C) The provisions of paragraphs (5), (6), 

16 and (7) of section 303(f) shall apply with re17 spect to a civil penalty under this paragraph to 

18 the same extent and in the same manner as 

19 such provisions apply with respect to a civil 

20 penalty under paragraph (1), (2), (3), (4), or 

21 (9) of section 303(f). 

22 ‘‘(c) NOTIFICATIONS BY SECRETARY.— 

23 ‘‘(1) DRUG SHORTAGE DEFINED.—In this sec24 tion, the term ‘drug shortage’ means, with respect to 

25 a drug, a period of time when the total supply of 


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1 such drug available at the user level will not meet 

2 the demand for such drug at the user level as deter3 mined by the Secretary. 

4 ‘‘(2) PUBLIC NOTIFICATION.— 

5 ‘‘(A) IN GENERAL.—Subject to subsection 

6 (b)(6), the Secretary shall— 

7 ‘‘(i) publish on the public Internet 

8 Web site of the Food and Drug Adminis9 tration information on— 

10 ‘‘(I) the types of discontinuances 

11 and interruptions for which a notifica12 tion is required under subsection 

13 (b)(1); and 

14 ‘‘(II) actual drug shortages; and 

15 ‘‘(ii) to the maximum extent prac16 ticable, distribute such information to ap17 propriate health care providers and patient 

18 organizations. 

19 ‘‘(B) DURATION.—The Secretary shall in20 clude in any publication or distribution under 

21 subparagraph (A), when possible, an estimate 

22 of the expected duration of any discontinuance 

23 or interruption or actual drug shortage. 

24 ‘‘(3) IDENTIFICATION AND NOTIFICATION OF

25 DRUGS VULNERABLE TO DRUG SHORTAGE.— 


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1 ‘‘(A) IN GENERAL.—If the Secretary deter2 mines using the criteria under subparagraph 

3 (B) that a drug may be vulnerable to a drug 

4 shortage, the Secretary shall notify the manu5 facturer of the drug of— 

6 ‘‘(i) such determination; and 

7 ‘‘(ii) the Secretary’s duty to collabo8 rate to improve continuity of supply plans 

9 under paragraph (4). 

10 ‘‘(B) EVIDENCE-BASED CRITERIA.—The 

11 Secretary shall implement evidence-based cri12 teria for identifying drugs that may be vulner13 able to a drug shortage. Such criteria shall be 

14 based on— 

15 ‘‘(i) the number of manufacturers of 

16 the drug; 

17 ‘‘(ii) the sources of raw material or 

18 active pharmaceutical ingredients; 

19 ‘‘(iii) the supply chain characteristics, 

20 such as production complexities; and 

21 ‘‘(iv) the availability of therapeutic al22 ternatives. 

23 ‘‘(4) CONTINUITY OF SUPPLY PLANS.— 

24 ‘‘(A) IN GENERAL.—With respect to drugs 

25 that are vulnerable to a drug shortage (as deVerDate Mar 15 2010 06:14 Jun 23, 2011 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2245.IH H2245

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1 termined under paragraph (3)), the Secretary 

2 shall collaborate with manufacturers and other 

3 stakeholders (such as distributors and health 

4 care providers) to establish and improve con5 tinuity of supply plans, so that such plans in6 clude a process for addressing drug shortages. 

7 ‘‘(B) LIMITATION ON SECRETARY’S AU8 THORITY.—The Secretary may not in any case 

9 require a manufacturer— 

10 ‘‘(i) to manufacture a drug in the 

11 event of a discontinuance or interruption; 

12 or 

13 ‘‘(ii) to delay or alter a discontinuance 

14 or interruption. 

15 ‘‘(C) ALLOCATION BY MANUFACTURER.— 

16 No provision of Federal law shall be construed 

17 to prohibit a manufacturer from, or penalize a 

18 manufacturer for, allocating distribution of its 

19 products in order to manage an actual or poten20 tial drug shortage. 

21 ‘‘(d) RULEMAKING.—The Secretary shall carry out 

22 this section pursuant to regulations promulgated after 

23 providing notice and an opportunity for comment.’’. 

24 (b) APPLICABILITY; TRANSITIONAL PERIOD.—Sec25 tion 506C of the Federal Food, Drug, and Cosmetic Act, 


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1 as amended by subsection (a), applies with respect to 

2 discontinuances, interruptions, and drug shortages (as 

3 such terms are used in such section 506C) that occur on 

4 or after the day that is 1 year after the date of the enact5 ment of this Act. Until such day, the provisions of section 

6 506C of the Federal Food, Drug, and Cosmetic Act, as 

7 in effect on the day before the enactment of this Act, shall 

8 continue to apply. 

9 SEC. 3. REPORTS TO CONGRESS. 

10 The Secretary of Health and Human Services shall 

11 submit to the Congress— 

12 (1) not later than the date that is 1 year after 

13 the date of the enactment of this Act, a report de14 scribing the actions taken by the Secretary during 

15 the previous 1-year period to address drug shortages 

16 (as defined in section 506C of the Federal Food, 

17 Drug, and Cosmetic Act, as amended by section 2) 

18 through all aspects of the prescription drug supply 

19 chain; and 

20 (2) every 5 years thereafter, a report describing 

21 such actions taken by the Secretary during the pre22 vious 5-year period. 

23 SEC. 4. GAO STUDY. 

24 (a) STUDY.—The Comptroller General of the United 

25 States shall conduct a study— 


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1 (1) to examine how the Food and Drug Admin2 istration identifies and responds to drug shortages 

3 (as defined in section 506C of the Federal Food, 

4 Drug, and Cosmetic Act, as amended by section 2); 

5 (2) to examine the possible causes of such drug 

6 shortages, including manufacturing problems, break7 down in the supply chain delivery system, changes in 

8 the supply of raw materials, stockpiling at the 

9 wholesale or provider level, and restrictive regulatory 

10 requirements; 

11 (3) to identify if there is adequate communica12 tion between industry, the Food and Drug Adminis13 tration, distributors, and end users; 

14 (4) to analyze the effects of the enactment of 

15 this Act on the ability of the Food and Drug Admin16 istration to identify and ameliorate such drug short17 ages; and 

18 (5) to identify any additional measures that 

19 need to be taken to prevent or address such drug 

20 shortages. 

21 (b) REPORT.—Not later than 1 year after the date 

22 of the enactment of this Act, the Comptroller General shall 

23 submit a report to the Congress on the results of the study 

24 under subsection (a). 

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