II 

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. 

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’’. 

6 SEC. 2. DRUG SHORTAGES. 

7 (a) EXPANSION OF NOTIFICATION REQUIREMENT

8 REGARDING POTENTIAL SHORTAGES OF PRESCRIPTION


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1 DRUGS.—Section 506C of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 356c) is amended— 

3 (1) in the section heading, by striking ‘‘DIS4 CONTINUANCE OF A LIFE SAVING PRODUCT’’ 

5 and inserting ‘‘DISCONTINUANCE OR INTERRUP6 TION OF THE MANUFACTURE OF A PRESCRIP7 TION DRUG’’; and 

8 (2) by amending subsection (a) to read as fol9 lows: 

10 ‘‘(a) IN GENERAL.— 

11 ‘‘(1) DEFINITION.—In this section, the terms 

12 ‘drug shortage’ and ‘shortage’, when used with re13 spect to a drug, mean a period of time when the 

14 total supply of all versions of a drug available at the 

15 user level will not meet the current demand for the 

16 drug at the user level. 

17 ‘‘(2) NOTIFICATION.—A manufacturer of a 

18 drug described in paragraph (3) shall notify the Sec19 retary of a discontinuance, interruption, or other ad20 justment of the manufacture of the drug that would 

21 likely result in a shortage of such drug— 

22 ‘‘(A) in the case of a discontinuance or 

23 planned interruption or adjustment, at least 6 

24 months prior to the date of such discontinuance 

25 or planned interruption or adjustment; and 


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1 ‘‘(B) in the case of any other interruption 

2 or adjustment, as soon as practicable after be3 coming aware of such interruption or adjust4 ment. 

5 ‘‘(3) DRUGS DESCRIBED.—A drug described in 

6 this paragraph is a drug— 

7 ‘‘(A) for which an application has been ap8 proved under section 505(b) or 505(j); 

9 ‘‘(B) that is described in section 503(b)(1); 

10 and 

11 ‘‘(C) that is not a product that was origi12 nally derived from human tissue and was re13 placed by a recombinant product. 

14 ‘‘(4) TYPES OF ADJUSTMENTS.—An adjustment 

15 for which a manufacturer shall submit a notification 

16 under paragraph (2) includes— 

17 ‘‘(A) adjustments related to the supply of 

18 raw materials, including active pharmaceutical 

19 ingredients; 

20 ‘‘(B) adjustments to production capabili21 ties; 

22 ‘‘(C) business decisions that may affect the 

23 manufacture of the drug, such as mergers, 

24 discontinuations, and a change in production 

25 output; and 


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1 ‘‘(D) other adjustments as determined ap2 propriate by the Secretary. 

3 ‘‘(5) MODIFICATION OF TIME FRAMES.—The 

4 Secretary may adjust the required time frame under 

5 paragraph (2) as determined appropriate by the Sec6 retary based on— 

7 ‘‘(A) the type of interruption or adjust8 ment at issue; and 

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

10 the Secretary. 

11 ‘‘(6) ENFORCEMENT.—Not later than 180 days 

12 after the date of enactment of this section, the Sec13 retary shall promulgate regulations establishing a 

14 schedule of civil monetary penalties for failure to 

15 submit a notification as required under this sub16 section.’’. 

17 (b) CONFIDENTIALITY OF INFORMATION.—Section 

18 506C(c) of the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 356c(c)) is amended to read as follows: 

20 ‘‘(c) CONFIDENTIALITY OF INFORMATION.—The Sec21 retary shall ensure the confidentiality of proprietary infor22 mation submitted in a notification under subsection (a).’’. 

23 (c) PUBLIC NOTIFICATION.—Section 506C of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) 

25 is amended by adding at the end the following: 


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1 ‘‘(d) PUBLIC NOTIFICATION.— 

2 ‘‘(1) NOTIFICATION OF SHORTAGES.—The Sec3 retary shall publish information on the types of ad4 justments for which a notification is required under 

5 subsection (a)(4) and on actual drug shortages on 

6 the Internet Web site of the Food and Drug Admin7 istration and, to the maximum extent practicable, 

8 distribute such information to appropriate health 

9 care provider and patient organizations. 

10 ‘‘(2) IDENTIFICATION AND NOTIFICATION OF

11 DRUGS VULNERABLE TO DRUG SHORTAGE.— 

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

13 implement evidence-based criteria for identi14 fying drugs that may be vulnerable to a drug 

15 shortage. Such criteria shall be based on— 

16 ‘‘(i) the number of manufacturers of 

17 the drug; 

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

19 active pharmaceutical ingredients; 

20 ‘‘(iii) the supply chain characteristics, 

21 such as production complexities; and 

22 ‘‘(iv) the availability of therapeutic al23 ternatives. 

24 ‘‘(B) NOTIFICATION.—If the Secretary de25 termines using the criteria under subparagraph 


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1 (A) that a drug may be vulnerable to a drug 

2 shortage, the Secretary shall notify the manu3 facturer of the drug of such determination and 

4 of the collaboration described under paragraph 

5 (3). 

6 ‘‘(3) CONTINUITY OF OPERATIONS PLANS.— 

7 The Secretary shall collaborate with manufacturers 

8 of drugs identified pursuant to paragraph (2) to es9 tablish and improve continuity of operations plans 

10 with respect to medically necessary drugs, as defined 

11 by the Secretary, so that such plans include a proc12 ess for addressing drug shortages.’’. 

13 SEC. 3. MANUFACTURER REVIEW. 

14 Section 510(h) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 360(h)) is amended— 

16 (1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 

17 and 

18 (2) by inserting at the end the following: 

19 ‘‘(2)(A) If an establishment registered with the Sec20 retary pursuant to this section is subject to a reinspection 

21 due to failure to comply with a requirement of this Act, 

22 the Secretary shall conduct such reinspection not later 

23 than 90 days after the establishment certifies to the Sec24 retary that the establishment has corrected the reason for 

25 such failure. 


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1 ‘‘(B) The Secretary shall prioritize reinspections de2 scribed in subparagraph (A) based on whether the estab3 lishment involved manufactures, propagates, compounds, 

4 or processes a drug involved in a drug shortage (as defined 

5 in section 506C).’’. 

6 SEC. 4. REPORTS TO CONGRESS. 

7 Not later than 1 year after the date of enactment 

8 of this Act, and on an annual basis thereafter, the Sec9 retary of Health and Human Services shall submit to Con10 gress a report that describes the actions taken by such 

11 Secretary during the previous 1-year period to address 

12 drug shortages through all aspects of the prescription 

13 drug supply chain. 

Æ 


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