II 

★(Star Print)

109TH CONGRESS 

2D SESSION S. 2300 

To amend the Federal Food, Drug, and Cosmetic Act with respect to market 

exclusivity for certain drugs, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 16, 2006 

Ms. STABENOW (for herself and Mr. LOTT) 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 with 

respect to market exclusivity for certain drugs, and for 

other purposes. 

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 ‘‘Lower Prices Reduced 

5 with Increased Competition and Efficient Development of 

6 Drugs Act’’ or the ‘‘Lower PRICED Drugs Act’’. 


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1 SEC. 2. GENERIC DRUG USE CERTIFICATION. 

2 (a) IN GENERAL.—Section 505(j)(2)(A) of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

4 355(j)(2)(A)) is amended— 

5 (1) in clause (vii), by striking ‘‘; and’’ and in6 serting a semicolon; 

7 (2) in clause (viii), by striking the period and 

8 inserting ‘‘; and’’; 

9 (3) by inserting after clause (viii) the following: 

10 ‘‘(ix) if with respect to a listed drug product re11 ferred to in clause (i) that contains an antibiotic 

12 drug and the antibiotic drug was the subject of any 

13 application for marketing received by the Secretary 

14 under section 507 (as in effect before the date of en15 actment of the Food and Drug Administration Mod16 ernization Act of 1997) before November 20, 1997, 

17 the approved labeling includes a method of use 

18 which, in the opinion of the applicant, is claimed by 

19 any patent, a statement that— 

20 ‘‘(I) identifies the relevant patent and the 

21 approved use covered by the patent; and 

22 ‘‘(II) the applicant is not seeking approval 

23 of such use under this subsection.’’; and 

24 (4) in the last sentence, by striking ‘‘clauses (i) 

25 through (viii)’’ and inserting ‘‘clauses (i) through 

26 (ix)’’. 


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1 (b) EFFECTIVE DATE.—The amendments made by 

2 this section shall apply to any abbreviated new drug appli3 cation under section 505(j) of the Federal Food, Drug, 

4 and Cosmetic Act (21 U.S.C. 355(j)) that is submitted 

5 on, before, or after the date of enactment of this Act. 

6 SEC. 3. PREVENTING ABUSE OF THE THIRTY-MONTH STAY7 OF-EFFECTIVENESS PERIOD. 

8 (a) IN GENERAL.—Section 505(j)(5)(B)(iii) of the 

9 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 355(j)(5)(B)(iii)) is amended— 

11 (1) in the second sentence by striking ‘‘may 

12 order’’ and inserting ‘‘shall order’’; and 

13 (2) by adding at the end the following: ‘‘In de14 termining whether to shorten the thirty-month pe15 riod under this clause, the court shall consider the 

16 totality of the circumstances, including whether the 

17 plaintiff sought to extend the discovery schedule, de18 layed producing discovery, or otherwise acted in a 

19 dilatory manner, and the public interest.’’. 

20 (b) EFFECTIVE DATE.—The amendments made by 

21 this section shall apply to any stay of effectiveness period 

22 under section 505(j)(5)(B)(iii) of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iii)) pending 

24 or filed on or after the date of enactment of this Act. 


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1 SEC. 4. ENSURING PROPER USE OF PEDIATRIC EXCLU2 SIVITY. 

3 (a) DRUG PRODUCT.—Section 505A of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 

5 amended by striking ‘‘drug’’ each place it appears and in6 serting ‘‘drug product’’. 

7 (b) MARKET EXCLUSIVITY FOR NEW DRUGS.—Sec8 tion 505A(b) of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 355a(b)) is amended— 

10 (1) in the matter preceding paragraph (1), by— 

11 (A) striking ‘‘health’’ and inserting ‘‘thera12 peutically meaningful’’; 

13 (B) striking ‘‘and’’ after ‘‘(which shall in14 clude a timeframe for completing such stud15 ies),’’; and 

16 (C) inserting ‘‘, and based on the results 

17 of such studies the Secretary approves labeling 

18 for the new drug product that provides specific, 

19 therapeutically meaningful information about 

20 the use of the drug product in pediatric pa21 tients’’ after ‘‘in accordance with subsection 

22 (d)(3)’’; 

23 (2) in paragraph (1)(A)— 

24 (A) in clause (i), by— 

25 (i) striking ‘‘the period’’ and inserting 

26 ‘‘any period’’; and 


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1 (ii) inserting ‘‘that is applicable to the 

2 drug product at the time of initial ap3 proval’’ after ‘‘in subsection (j)(5)(F)(ii) of 

4 such section’’; and 

5 (B) in clause (ii), by— 

6 (i) striking ‘‘the period’’ and inserting 

7 ‘‘any period’’; and 

8 (ii) inserting ‘‘that is applicable to the 

9 drug product at the time of initial ap10 proval’’ after ‘‘of subsection (j)(5)(F) of 

11 such section’’; and 

12 (3) in paragraph (2)— 

13 (A) in subparagraph (A)— 

14 (i) in clause (i), by striking ‘‘a listed 

15 patent’’ and inserting ‘‘a patent that was 

16 either listed when the pediatric study was 

17 submitted to the Food and Drug Adminis18 tration or listed as a result of the approval 

19 by the Food and Drug Administration of 

20 new pediatric labeling that is claimed by 

21 the patent, and’’; and 

22 (ii) in clause (ii) by striking ‘‘a listed 

23 patent’’ and inserting ‘‘a patent that was 

24 either listed when the pediatric study was 

25 submitted to the Food and Drug AdminisVerDate Aug 31 2005 04:50 Feb 28, 2006 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2300.IS S2300

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1 tration or listed as a result of the approval 

2 by the Food and Drug Administration of 

3 new pediatric labeling that is claimed by 

4 the patent, and’’; and 

5 (B) in subparagraph (B), by striking ‘‘a 

6 listed patent’’ and inserting ‘‘a patent that was 

7 either listed when the pediatric study was sub8 mitted to the Food and Drug Administration or 

9 listed as a result of the approval by the Food 

10 and Drug Administration of new pediatric label11 ing that is claimed by the patent, and’’. 

12 (c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED

13 DRUGS.—Section 505A(c) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 355a(c)) is amended— 

15 (1) in the matter preceding paragraph (1), by— 

16 (A) striking ‘‘health’’ and inserting ‘‘thera17 peutically meaningful’’; 

18 (B) striking ‘‘and’’ after ‘‘the studies are 

19 completed within any such timeframe,’’; and 

20 (C) inserting ‘‘, and based on the results 

21 of such studies the Secretary approves labeling 

22 for the approved drug product that provides 

23 specific, therapeutically meaningful information 

24 about the use of the drug product in pediatric 


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1 patients’’ after ‘‘in accordance with subsection 

2 (d)(3)’’; 

3 (2) in paragraph (1)(A)— 

4 (A) in clause (i)— 

5 (i) by striking ‘‘the period’’ and in6 serting ‘‘any period’’; and 

7 (ii) by inserting ‘‘that is applicable to 

8 the drug product at the time of initial ap9 proval’’ after ‘‘in subsection (j)(5)(F)(ii) of 

10 such section’’; and 

11 (B) in clause (ii)— 

12 (i) by striking ‘‘the period’’ and in13 serting ‘‘any period’’; and 

14 (ii) by inserting ‘‘that is applicable to 

15 the drug product at the time of initial ap16 proval’’ after ‘‘of subsection (j)(5)(F) of 

17 such section’’; and 

18 (3) in paragraph (2)— 

19 (A) in subparagraph (A)— 

20 (i) in clause (i), by striking ‘‘a listed 

21 patent’’ and inserting ‘‘a patent that was 

22 either listed when the pediatric study was 

23 submitted to the Food and Drug Adminis24 tration or listed as a result of the approval 

25 by the Food and Drug Administration of 


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1 new pediatric labeling that is claimed by 

2 the patent, and’’; and 

3 (ii) in clause (ii), by striking ‘‘a listed 

4 patent’’ and inserting ‘‘a patent that was 

5 either listed when the pediatric study was 

6 submitted to the Food and Drug Adminis7 tration or listed as a result of the approval 

8 by the Food and Drug Administration of 

9 new pediatric labeling that is claimed by 

10 the patent, and’’; and 

11 (B) in subparagraph (B), by striking ‘‘a 

12 listed patent’’ and by inserting ‘‘a patent that 

13 was either listed when the pediatric study was 

14 submitted to the Food and Drug Administra15 tion or listed as a result of the approval by the 

16 Food and Drug Administration of new pediatric 

17 labeling that is claimed by the patent, and’’. 

18 (d) THREE-MONTH EXCLUSIVITY.—Section 505A of 

19 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

20 355a) is amended by— 

21 (1) by striking ‘‘six months’’ each place it ap22 pears and inserting ‘‘three months’’; 

23 (2) by striking ‘‘six-month’’ each place it ap24 pears and inserting ‘‘three-month’’; 


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1 (3) by striking ‘‘6-month’’ each place it appears 

2 and inserting ‘‘three-month’’; 

3 (4) in subsection (b)(1)(A)(i), by striking ‘‘four 

4 and one-half years, fifty-four months, and eight 

5 years, respectively’’ and inserting ‘‘four years and 

6 three months, fifty-one months, and seven years and 

7 nine months, respectively’’; and 

8 (5) in subsection (c)(1)(A)(i), by striking ‘‘four 

9 and one-half years, fifty-four months, and eight 

10 years, respectively’’ and inserting ‘‘four years and 

11 three months, fifty-one months, and seven years and 

12 nine months, respectively’’. 

13 (e) DEFINITION.—Section 505A of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 355a) is amended by 

15 adding at the end the following: 

16 ‘‘(o) DRUG PRODUCT.— 

17 ‘‘(1) IN GENERAL.—For purposes of this sec18 tion, the term ‘drug product’ has the same meaning 

19 given such term in section 314.3(b) of title 21, Code 

20 of Federal Regulations (or any successor regulation). 

21 ‘‘(2) SEPARATE DRUG PRODUCTS.—For pur22 poses of this section, each dosage form of a drug 

23 product shall constitute a different drug product.’’. 


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1 (f) TECHNICAL CORRECTIONS.—Section 505A of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 

3 is amended— 

4 (1) by striking ‘‘subsection (c)(3)(D)’’ each 

5 place it appears and inserting ‘‘subsection 

6 (c)(3)(E)’’; and 

7 (2) in subsection (n), by striking ‘‘under sub8 section (a) or (c)’’ and inserting ‘‘under subsection 

9 (b) or (c)’’. 

10 (g) EFFECTIVE DATE.—The amendments made by 

11 this section shall apply to requests by the Secretary of 

12 Health and Human Services for pediatric studies under 

13 section 505A of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 355a) after the date of enactment of this 

15 Act. 

16 SEC. 5. CITIZEN PETITIONS AND PETITIONS FOR STAY OF 

17 AGENCY ACTION. 

18 Section 505 of the Federal Food, Drug, and Cosmetic 

19 Act (21 U.S.C. 355) is amended by adding at the end the 

20 following: 

21 ‘‘(o) CITIZENS PETITIONS AND PETITIONS FOR STAY

22 OF AGENCY ACTION.—With respect to any petition that 

23 seeks to have the Secretary take, or refrain from taking, 

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1 tion submitted under subsection (b)(2) or (j), the following 

2 shall apply: 

3 ‘‘(1) NO DELAY OF APPROVAL.—The Secretary 

4 shall not delay approval of an application submitted 

5 under subsection (b)(2) or (j) while a petition is re6 viewed and considered. Consideration of a petition 

7 shall be separate and apart from the review and ap8 proval of an application submitted under either such 

9 subsection. 

10 ‘‘(2) TIMING OF FINAL AGENCY ACTION.—The 

11 Secretary shall take final agency action with respect 

12 to a petition within six months of receipt of that pe13 tition. The Secretary shall not extend such six14 month review period, even with consent of the peti15 tioner, for any reason, including based upon the sub16 mission of comments relating to a petition or supple17 mental information supplied by the petitioner. If the 

18 Secretary has not taken final agency action on a pe19 tition by the date that is six months after the date 

20 of receipt of the petition, such petition shall be 

21 deemed to have been denied on such date. 

22 ‘‘(3) VERIFICATION.—The Secretary shall not 

23 accept for review a petition unless it is signed and 

24 contains the following verification: ‘I certify that, to 

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1 cludes all information and views upon which the pe2 tition relies; (b) this petition includes representative 

3 data and/or information known to the petitioner 

4 which are unfavorable to the petition; and (c) I have 

5 taken reasonable steps to ensure that any represent6 ative data and/or information which are unfavorable 

7 to the petition were disclosed to me. I further certify 

8 that the information upon which I have based the 

9 action requested herein first became known to the 

10 party on whose behalf this petition is filed on or 

11 about llllllllll. I verify under pen12 alty of perjury that the foregoing is true and cor13 rect.’, with the date of the filing of such petition in14 serted in the blank space. 

15 ‘‘(4) EXTENSION OF PERIOD.—The thirty16 month period referred to in subsection 

17 (j)(5)(D)(i)(IV) shall automatically be extended by 

18 the amount of time that lapses from the date that 

19 the Secretary receives a petition and the date of 

20 final agency action on that petition, without regard 

21 to whether the Secretary grants, in whole or in part, 

22 or denies, in whole or in part, that petition.’’. 

Æ 


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