I 

113TH CONGRESS 

2D SESSION H. R. 5750 

To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6- 

month extension of certain exclusivity periods in the case of approved 

drugs that are subsequently approved for a new indication to prevent, 

diagnose, or treat a rare disease or condition, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 20, 2014 

Mr. BILIRAKIS (for himself, Mr. BUTTERFIELD, Mr. MCCAUL, and Mr. HASTINGS of Florida) 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 

authorize a 6-month extension of certain exclusivity periods in the case of approved drugs that are subsequently 

approved for a new indication to prevent, diagnose, or 

treat a rare disease or condition, 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 ‘‘Orphan Product Ex5 tensions Now Accelerating Cures and Treatments Act of 

6 2014’’. 

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1 SEC. 2. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG 

2 APPROVED FOR A NEW INDICATION FOR A 

3 RARE DISEASE OR CONDITION. 

4 (a) IN GENERAL.—Chapter V of the Federal Food, 

5 Drug, and Cosmetic Act is amended by inserting after sec6 tion 505E of such Act (21 U.S.C. 355f) the following: 

7 ‘‘SEC. 505F. EXTENSION OF EXCLUSIVITY PERIODS FOR A 

8 DRUG APPROVED FOR A NEW INDICATION 

9 FOR A RARE DISEASE OR CONDITION. 

10 ‘‘(a) DESIGNATION.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall des12 ignate a drug as a drug approved for a new indica13 tion to prevent, diagnose, or treat a rare disease or 

14 condition for purposes of granting the extensions 

15 under subsection (b) if— 

16 ‘‘(A) prior to approval of an application or 

17 supplemental application for the new indication, 

18 the drug was approved or licensed for mar19 keting under section 505(c) of this Act or sec20 tion 351(a) of the Public Health Service Act, 

21 but was not so approved or licensed for the new 

22 indication; 

23 ‘‘(B)(i) the sponsor of the approved or li24 censed drug files an application or a supple25 mental application for approval of the new indimstockstill on DSK4VPTVN1PROD with BILLS

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1 cation for use of the drug to prevent, diagnose, 

2 or treat the rare disease or condition; and 

3 ‘‘(ii) the Secretary approves the application 

4 or supplemental application; and 

5 ‘‘(C) the application or supplemental appli6 cation for the new indication contains the con7 sent of the applicant to notice being given by 

8 the Secretary under paragraph (4) respecting 

9 the designation of the drug. 

10 ‘‘(2) REVOCATION OF DESIGNATION.— 

11 ‘‘(A) IN GENERAL.—Except as provided in 

12 subparagraph (B), a designation under this 

13 subsection shall not be revoked for any reason. 

14 ‘‘(B) EXCEPTION.—The Secretary may re15 voke a designation of a drug under paragraph 

16 (1) if the Secretary finds that the application or 

17 supplemental application resulting in such des18 ignation contained an untrue statement of ma19 terial fact. 

20 ‘‘(3) NOTIFICATION PRIOR TO DISCONTINUANCE

21 OF PRODUCTION FOR SOLELY COMMERCIAL REA22 SONS.—A designation of a drug under paragraph (1) 

23 shall be subject to the condition that the sponsor of 

24 the drug will notify the Secretary of any discontinu25 ance of the production of the drug for solely commstockstill on DSK4VPTVN1PROD with BILLS

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1 mercial reasons at least one year before such dis2 continuance. 

3 ‘‘(4) NOTICE TO PUBLIC.—Notice respecting 

4 the designation of a drug under paragraph (1) shall 

5 be made available to the public. 

6 ‘‘(b) EXTENSION.—If the Secretary designates a 

7 drug as a drug approved for a new indication for a rare 

8 disease or condition, as described in subsection (a)(1)— 

9 ‘‘(1)(A) the 4-, 5-, and seven and one-half year 

10 periods described in subsections (c)(3)(E)(ii) and 

11 (j)(5)(F)(ii) of section 505, the 3-year periods de12 scribed in clauses (iii) and (iv) of subsection 

13 (c)(3)(E) and clauses (iii) and (iv) of subsection 

14 (j)(5)(F) of section 505, and the 7-year period de15 scribed in section 527, as applicable, shall be ex16 tended by 6 months; or 

17 ‘‘(B) the 4- and 12-year periods described in 

18 subparagraphs (A) and (B) of section 351(k)(7) of 

19 the Public Health Service Act and the 7-year period 

20 described in section 527, as applicable, shall be ex21 tended by 6 months; and 

22 ‘‘(2) if, at the time a drug is designated under 

23 subsection (a)(1)— 

24 ‘‘(A) the drug is the subject of a listed pat25 ent for which a certification has been submitted 

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1 under subsection (b)(2)(A)(ii) or 

2 (j)(2)(A)(vii)(II) of section 505 or a listed pat3 ent for which a certification has been submitted 

4 under subsections (b)(2)(A)(iii) or 

5 (j)(2)(A)(vii)(III) of section 505, the period 

6 during which an application may not be ap7 proved under section 505(c)(3) or section 

8 505(j)(5)(B) shall be extended by a period of 6 

9 months after the date the patent expires (in10 cluding any patent extensions); or 

11 ‘‘(B) the drug is the subject of a listed 

12 patent for which a certification has been sub13 mitted under subsection (b)(2)(A)(iv) or 

14 (j)(2)(A)(vii)(IV) of section 505, and in the pat15 ent infringement litigation resulting from the 

16 certification the court determines that the pat17 ent is valid and would be infringed, the period 

18 during which an application may not be ap19 proved under section 505(c)(3) or section 

20 505(j)(5)(B) shall be extended by a period of 6 

21 months after the date the patent expires (in22 cluding any patent extensions). 

23 ‘‘(c) RELATION TO PEDIATRIC AND QUALIFIED IN24 FECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any exten25 sion under subsection (b) of a period shall be in addition 

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1 to any extension of the periods under sections 505A and 

2 505E of this Act and section 351(m) of the Public Health 

3 Service Act, as applicable, with respect to the drug. 

4 ‘‘(d) LIMITATIONS.—The extension described in sub5 section (b) shall not apply if the drug designated under 

6 subsection (a)(1) has previously received an extension by 

7 operation of subsection (b). 

8 ‘‘(e) REGULATIONS.— 

9 ‘‘(1) IN GENERAL.—Not later than 2 years 

10 after the date of enactment of this section, the Sec11 retary shall adopt final regulations implementing 

12 this section. 

13 ‘‘(2) PROCEDURE.—In promulgating a regula14 tion implementing this section, the Secretary shall— 

15 ‘‘(A) issue a notice of proposed rulemaking 

16 that includes the proposed regulation; 

17 ‘‘(B) provide a period of not less than 60 

18 days for comments on the proposed regulation; 

19 and 

20 ‘‘(C) publish the final regulation not less 

21 than 30 days before the effective date of the 

22 regulation. 

23 ‘‘(3) RESTRICTIONS.—Notwithstanding any 

24 other provision of law, the Secretary shall promul25 gate regulations implementing this section only as 

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1 described in paragraph (2), except that the Sec2 retary may issue interim guidance for sponsors seek3 ing to submit an application or supplemental appli4 cation described in subsection (a) prior to the pro5 mulgation of such regulations. 

6 ‘‘(4) DESIGNATION PRIOR TO REGULATIONS.— 

7 The Secretary shall designate drugs under sub8 section (a) prior to the promulgation of regulations 

9 under this subsection, if such drugs meet the criteria 

10 described in subsection (a). 

11 ‘‘(f) DEFINITION.—In this section, the term ‘rare dis12 ease or condition’ has the meaning given to such term in 

13 section 526(a)(2).’’. 

14 (b) APPLICATION.—Section 505F of the Federal 

15 Food, Drug, and Cosmetic Act, as added by subsection 

16 (a), applies only with respect to a drug for which an appli17 cation or supplemental application described in subsection 

18 (a)(1)(B)(i) of such section 505F is first approved under 

19 section 505(c) of such Act (21 U.S.C. 355(c)) or section 

20 351(a) of the Public Health Service Act (42 U.S.C. 

21 262(a)) on or after the date of the enactment of this Act. 

22 (c) CONFORMING AMENDMENTS.— 

23 (1) RELATION TO PEDIATRIC EXCLUSIVITY FOR

24 DRUGS.—Section 505A of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 355a) is amended— 

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1 (A) in subsection (b), by adding at the end 

2 the following: 

3 ‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG

4 APPROVED FOR A NEW INDICATION FOR A RARE DIS5 EASE OR CONDITION.—Notwithstanding the ref6 erences in subsection (b)(1) to the lengths of the ex7 clusivity periods after application of pediatric exclu8 sivity, the 6-month extensions described in sub9 section (b)(1) shall be in addition to any extensions 

10 under section 505F.’’; and 

11 (B) in subsection (c), by adding at the end 

12 the following: 

13 ‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG

14 APPROVED FOR A NEW INDICATION FOR A RARE DIS15 EASE OR CONDITION.—Notwithstanding the ref16 erences in subsection (c)(1) to the lengths of the ex17 clusivity periods after application of pediatric exclu18 sivity, the 6-month extensions described in sub19 section (c)(1) shall be in addition to any extensions 

20 under section 505F.’’. 

21 (2) RELATION TO EXCLUSIVITY FOR NEW

22 QUALIFIED INFECTIOUS DISEASE PRODUCTS THAT

23 ARE DRUGS.—Subsection (b) of section 505E of the 

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

25 355f) is amended— 

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1 (A) by amending the subsection heading to 

2 read as follows: ‘‘RELATION TO PEDIATRIC EX3 CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP4 PROVED FOR A NEW INDICATION FOR A RARE

5 DISEASE OR CONDITION’’; and 

6 (B) by striking ‘‘any extension of the pe7 riod under section 505A’’ and inserting ‘‘any 

8 extension of the periods under sections 505A or 

9 505F’’. 

10 (3) RELATION TO PEDIATRIC EXCLUSIVITY FOR

11 BIOLOGICAL PRODUCTS.—Section 351(m) of the 

12 Public Health Service Act (42 U.S.C. 262(m)) is 

13 amended by adding at the end the following: 

14 ‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO15 LOGICAL PRODUCT APPROVED FOR A NEW INDICA16 TION FOR A RARE DISEASE OR CONDITION.—Not17 withstanding the references in paragraphs (2)(A), 

18 (2)(B), (3)(A), and (3)(B) to the lengths of the ex19 clusivity periods after application of pediatric exclu20 sivity, the 6-month extensions described in such 

21 paragraphs shall be in addition to any extensions 

22 under section 505F.’’. 

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