II 

110TH CONGRESS 

1ST SESSION S. 1088 

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 

APRIL 11, 2007 

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) IN GENERAL.—Section 505A of the Federal 

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

5 amended by striking subsections (b) and (c) and inserting 

6 the following: 

7 ‘‘(b) MARKET EXCLUSIVITY FOR NEW DRUGS.— 

8 ‘‘(1) IN GENERAL.—With respect to a pending 

9 application under section 505(b)(1), each of the pe10 riods of time under this chapter specified in para11 graph (2) that is applicable with respect to the drug 

12 involved is deemed to be extended by the period of 

13 time determined under subsection (d) if, prior to ap14 proval of such application— 

15 ‘‘(A) the Secretary determines that infor16 mation relating to the use in the pediatric pop17 ulation of the drug may produce health benefits 

18 in that population; 

19 ‘‘(B) the Secretary makes a written re20 quest to the sponsor of the application for one 

21 or more pediatric studies, which request shall 

22 include a timeframe for completing such stud23 ies; 

24 ‘‘(C) the sponsor agrees to the request; 

25 ‘‘(D) such studies are completed within 

26 any such timeframe and the reports thereof 

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1 submitted in accordance with subsection (e)(2) 

2 or accepted in accordance with subsection 

3 (e)(3); and 

4 ‘‘(E) based on the results of such studies, 

5 the Secretary approves labeling for the drug 

6 that provides specific, therapeutically meaning7 ful information about the use of the drug in pe8 diatric patients. 

9 ‘‘(2) PERIOD OF TIME TO BE EXTENDED.—For 

10 purposes of paragraph (1), the periods of time under 

11 this chapter that are specified in this paragraph 

12 with respect to the drug involved are the following: 

13 ‘‘(A) In section 505: 

14 ‘‘(i) In each of subsections 

15 (c)(3)(E)(ii) and (j)(5)(F)(ii): 

16 ‘‘(I) The period of five years. 

17 ‘‘(II) The period of four years, 

18 the period of forty-eight months, and 

19 the period of seven and one-half years. 

20 ‘‘(ii) In each of clauses (iii) and (iv) 

21 of subsection (c)(3)(E), and in each of 

22 clauses (iii) and (iv) of subsection 

23 (j)(5)(F), the period of three years. 

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1 ‘‘(B) In section 527(a), the period of seven 

2 years, in the case of a drug designated under 

3 section 526 for a rare disease or condition. 

4 ‘‘(C) In section 505, under subsections 

5 (c)(3) and (j)(5)(B), the period of time during 

6 which the approval of an application may not be 

7 made effective, in the case of a drug that— 

8 ‘‘(i) is the subject of a qualifying list9 ed patent for which a certification has been 

10 submitted under subsection (b)(2)(A)(ii) or 

11 (j)(2)(A)(vii)(II) of such section and for 

12 which pediatric studies were submitted 

13 prior to the expiration of the patent (in14 cluding any patent extensions); 

15 ‘‘(ii) is the subject of a qualifying list16 ed patent for which a certification has been 

17 submitted under subsections (b)(2)(A)(iii) 

18 or (j)(2)(A)(vii)(III) of such section; or 

19 ‘‘(iii) is the subject of a qualifying 

20 listed patent for which a certification has 

21 been submitted under subsection 

22 (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of such 

23 section, and with respect to which, in the 

24 patent infringement litigation resulting 

25 from the certification, the court determines 

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1 that the patent is valid and would be in2 fringed. 

3 With respect to subparagraph (C), the extension of 

4 time that applies under this subsection begins on the 

5 day after the date of the expiration of the patent in6 volved (including any patent extension). 

7 ‘‘(3) QUALIFYING LISTED PATENT.—With re8 spect to a study submitted pursuant to paragraph 

9 (1), information on the patent must be filed with the 

10 Secretary as required under subsection (b)(1) or 

11 (c)(2) of section 505 as of the date on which the 

12 study was submitted to the Secretary pursuant to 

13 paragraph (1) in order to be considered a qualifying 

14 listed patent for purposes of this subsection. 

15 ‘‘(c) MARKET EXCLUSIVITY FOR ALREADY-MAR16 KETED DRUGS.— 

17 ‘‘(1) IN GENERAL.—With respect to an ap18 proved application under section 505(b)(1), each of 

19 the periods of time under this chapter specified in 

20 paragraph (2) that is applicable with respect to the 

21 drug involved is deemed to be extended by the period 

22 of time determined under subsection (d) if— 

23 ‘‘(A) the Secretary determines that infor24 mation relating to the use in the pediatric popmstockstill on PROD1PC66 with BILLS

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1 ulation of the drug may produce health benefits 

2 in that population; 

3 ‘‘(B) the Secretary makes a written re4 quest to the holder of such application for one 

5 or more pediatric studies, which request shall 

6 include a timeframe for completing such stud7 ies; 

8 ‘‘(C) the holder agrees to the request; 

9 ‘‘(D) such studies are completed within 

10 any such timeframe and the reports thereof 

11 submitted in accordance with subsection (e)(2) 

12 or accepted in accordance with subsection 

13 (e)(3); and 

14 ‘‘(E) based on the results of such studies, 

15 the Secretary approves labeling for the drug 

16 that provides specific, therapeutically meaning17 ful information about the use of the drug in pe18 diatric patients. 

19 ‘‘(2) PERIOD OF TIME TO BE EXTENDED.—For 

20 purposes of paragraph (1), the periods of time under 

21 this chapter that are specified in this paragraph are 

22 the periods of time referred to in subsection (b)(2), 

23 as applied to the drug referred to in paragraph (1). 

24 With respect to periods of time referred to in sub25 section (b)(2)(C) as applied to such drug, the extenmstockstill on PROD1PC66 with BILLS

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1 sion of time that applies under this subsection be2 gins on the day after the date of the expiration of 

3 the patent involved (including any patent extension). 

4 ‘‘(3) QUALIFYING LISTED PATENT.—With re5 spect to a study submitted pursuant to paragraph 

6 (1), a patent concerning a drug is a qualifying listed 

7 patent for purposes of this subsection if the patent 

8 meets the condition described in subsection (b)(3), 

9 as applied to the drug referred to in paragraph 

10 (1).’’. 

11 (b) LENGTH OF EXTENSION PERIOD.—Section 505A 

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

13 355a) is amended— 

14 (1) by redesignating subsections (d) through 

15 (n) as subsections (e) through (o), respectively; and 

16 (2) by inserting after subsection (c) the fol17 lowing: 

18 ‘‘(d) DETERMINATION OF EXTENSION PERIOD.— 

19 ‘‘(1) IN GENERAL.—For purposes of sub20 sections (b) and (c), the extension period determined 

21 under this subsection with respect to a drug is the 

22 following, as applicable: 

23 ‘‘(A) 3 months, if the sales revenue for the 

24 same active moiety that is projected under 

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1 paragraph (3) for the base year is 

2 $1,000,000,000 or more. 

3 ‘‘(B) 6 months, if the sales revenue for the 

4 same active moiety that is projected under 

5 paragraph (3) for the base year is less than 

6 $1,000,000,000. 

7 ‘‘(2) BASE YEAR.—For purposes of this sub8 section, the base year for the same active moiety is 

9 the preceding 12 months from the date which mar10 ket exclusivity under Federal law for the drug would 

11 expire in the absence of an extension under sub12 section (b) or (c). 

13 ‘‘(3) PROJECTION OF SALES REVENUE.— 

14 ‘‘(A) IN GENERAL.—For purposes of para15 graph (1), the Secretary shall make an estimate 

16 of the sales revenue for a drug for a base year 

17 on the basis of the sales histories of an appro18 priate sample of drugs over the 20-year period 

19 preceding the date of the enactment of the 

20 Lower PRICED Drugs Act, including data on 

21 the sales revenue of the drug that has been in22 cluded in reports by IMS Health. 

23 ‘‘(B) TIMING OF PROJECTION.—An esti24 mate under subparagraph (A) for a drug shall 

25 be a projection made in advance of the base 

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1 year for the drug. In the case of an extension 

2 period under subsection (b), the projection may 

3 not be made earlier than the expiration of the 

4 2-year period beginning on the date on which 

5 the drug is approved by the Secretary under 

6 section 505, unless all market exclusivity under 

7 Federal law for the drug will, in the absence of 

8 an extension under subsection (b), expire before 

9 the expiration of such period, in which case the 

10 projection shall be determined not later than 3 

11 months before the beginning of the base year. 

12 ‘‘(C) IMS HEALTH.—The reference in sub13 paragraph (A)(ii) to IMS Health is a reference 

14 to the corporation Intercontinental Marketing 

15 Services, first established in 1954, whose activi16 ties include the conduct of syndicated market 

17 research studies of the pharmaceutical industry 

18 and the international monitoring of prescription 

19 drug sales. 

20 ‘‘(4) CRITERIA.—The Secretary shall by regula21 tion establish criteria for making projections under 

22 paragraph (1).’’. 

23 (c) FINAL RULE FOR CRITERIA FOR PROJECTION OF

24 SALES REVENUE; EFFECTIVE DATE.— 

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1 (1) FINAL RULE.—With respect to criteria 

2 under subsection (d)(4) of section 505A of the Fed3 eral Food, Drug, and Cosmetic Act, as added by 

4 subsection (b) of this section, the Secretary of 

5 Health and Human Services shall promulgate the 

6 final rule not later than 180 days after the date of 

7 enactment of this Act. 

8 (2) EFFECTIVE DATE.—The amendments made 

9 by this subsection take effect 180 days after the 

10 date of enactment of this Act, without regard to 

11 whether the final rule under paragraph (1) has been 

12 promulgated, subject to subsection (e). The pre13 ceding sentence does not affect the requirement 

14 under paragraph (1) for the Secretary to promulgate 

15 a final rule, notwithstanding circumstances under 

16 the preceding sentence in which such amendments 

17 have taken effect in the absence of a final rule. 

18 (d) CONFORMING AMENDMENTS; TECHNICAL COR19 RECTIONS.—Section 505A of the Federal Food, Drug, and 

20 Cosmetic Act (21 U.S.C. 355a), as amended by subsection 

21 (b)(1), is amended— 

22 (1) in subsection (e)(4)(C), by inserting ‘‘of the 

23 Public Health Service Act’’ after ‘‘499(j)(9)(B)(i)’’; 

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1 (2) in subsection (f), by striking ‘‘subsection 

2 (c)(3)(D)’’ each place it appears and inserting ‘‘sub3 section (c)(3)(E)’’; 

4 (3) in each of subsections (f) and (g), by strik5 ing ‘‘subsection (d)’’ each place such term appears 

6 and inserting ‘‘subsection (e)’’; and 

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

9 (b) or (c)’’. 

10 (e) 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 a pending applica23 tion submitted under subsection (b)(2) or (j), if a petition 

24 is submitted to the Secretary that seeks to have the Sec25 retary take, or refrain from taking, any form of action 

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1 relating to the approval of the application, including a 

2 delay in the effective date of the application, the following 

3 shall apply: 

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

5 shall not delay approval of an application submitted 

6 under subsection (b)(2) or (j) while a petition is re7 viewed and considered. Consideration of a petition 

8 shall be separate and apart from the review and ap9 proval of an application submitted under either such 

10 subsection. 

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

12 Secretary shall take final agency action with respect 

13 to a petition within 180 days of submission of that 

14 petition. The Secretary shall not extend such 180- 

15 day review period, even with consent of the peti16 tioner, for any reason, including based upon the sub17 mission of comments relating to a petition or supple18 mental information supplied by the petitioner. If the 

19 Secretary has not taken final agency action on a pe20 tition by the date that is 180 days after the date of 

21 submission of the petition, such petition shall be 

22 deemed to have been denied on such date. 

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

24 accept for review a petition unless it is signed and 

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

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1 my best knowledge and belief: (a) this petition in2 cludes all information and views upon which the pe3 tition relies; (b) this petition includes representative 

4 data and/or information known to the petitioner 

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

6 taken reasonable steps to ensure that any represent7 ative data and/or information which are unfavorable 

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

9 that the information upon which I have based the 

10 action requested herein first became known to the 

11 party on whose behalf this petition is filed on or 

12 about llllllllll. I received or expect 

13 to receive payments, including cash and other forms 

14 of consideration, from the following persons or orga15 nizations to file this petition: 

16 llllllllll. I verify under penalty of 

17 perjury that the foregoing is true and correct.’, with 

18 the date of the filing of such petition being inserted 

19 in the first blank space, and the appropriate names 

20 of persons or organizations being inserted in the sec21 ond blank space. 

22 ‘‘(4) EXTENSION OF PERIOD.—The thirty23 month period referred to in subsection 

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

25 the amount of time that lapses from the date that 

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1 the Secretary receives a petition and the date of 

2 final agency action on that petition, without regard 

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

4 or denies, in whole or in part, that petition. 

5 ‘‘(5) EXHAUSTION OF ADMINISTRATIVE REM6 EDIES.— 

7 ‘‘(A) FINAL AGENCY ACTION WITHIN 180

8 DAYS.—The Secretary shall be considered to 

9 have take final agency action on a petition re10 ferred to in this subsection if— 

11 ‘‘(i) during the 180-day period re12 ferred to in paragraph (2), the Secretary 

13 makes a final decision within the meaning 

14 of section 10.45(d) of title 21, Code of 

15 Federal Regulations (or any successor reg16 ulation); or 

17 ‘‘(ii) such period expires without the 

18 Secretary having made such a final deci19 sion. 

20 ‘‘(B) DISMISSAL OF CERTAIN CIVIL AC21 TIONS.—If a civil action is filed with respect to 

22 a petition referred to in this subsection before 

23 final agency action, the court shall dismiss the 

24 action for failure to exhaust administrative rem25 edies. 

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1 ‘‘(6) ANNUAL REPORT ON DELAYS IN APPROV2 ALS PER PETITION.—The Secretary shall annually 

3 submit to Congress a report that specifies— 

4 ‘‘(A) the number of applications under 

5 subsections (b)(2) and (j) that were approved 

6 during the preceding 12-month period; 

7 ‘‘(B) the number of petitions described in 

8 this subsection that were submitted during such 

9 period; 

10 ‘‘(C) the number of such applications 

11 whose effective dates were delayed by such peti12 tions during such period; and 

13 ‘‘(D) the number of days by which the ap14 plications were so delayed. 

15 ‘‘(7) EXCEPTION.—This subsection does not 

16 apply to a petition that is made by the sponsor of 

17 the application under subsection (b)(2) or (j) and 

18 that seeks only to have the Secretary take or refrain 

19 from taking any form of action with respect to that 

20 application. 

21 ‘‘(8) DEFINITION.—For purposes of this sub22 section, the term ‘petition’ includes any request to 

23 the Secretary, without regard to whether the request 

24 is characterized as a petition.’’. 

Æ 

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