II 

115TH CONGRESS 

1ST SESSION S. 1509 

To amend the Federal Food, Drug, and Cosmetic Act to authorize an extension of exclusivity periods for certain drugs that are approved for a 

new indication for a rare disease or condition, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 29, 2017 

Mr. HATCH (for himself and Mr. MENENDEZ) 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 

authorize an extension of exclusivity periods for certain 

drugs that are approved for a new indication for 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 Products Ex5 tension Now Accelerating Cures and Treatments Act of 

6 2017’’. 

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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.—The Federal Food, Drug, and 

5 Cosmetic Act is amended by inserting after section 505F 

6 of such Act (21 U.S.C. 355g) the following: 

7 ‘‘SEC. 505G. 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 under section 

19 505(c) of this Act or section 351(a) of the Pub20 lic Health Service Act but was not so approved 

21 or licensed for the new indication; 

22 ‘‘(B)(i) the sponsor of the approved or li23 censed drug files an application or a supple24 mental application for approval of the new indi25 cation for use of the drug to prevent, diagnose, 

26 or treat the rare disease or condition; and 

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1 ‘‘(ii) the Secretary approves the application 

2 or supplemental application; and 

3 ‘‘(C) the application or supplemental appli4 cation for the new indication contains the con5 sent of the applicant to public notice under 

6 paragraph (3) with respect to the designation of 

7 the drug. 

8 ‘‘(2) REVOCATION OF DESIGNATION.— 

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

10 subparagraph (B), a designation under para11 graph (1) shall not be revoked for any reason. 

12 ‘‘(B) EXCEPTION.—The Secretary may re13 voke a designation of a drug under paragraph 

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

15 supplemental application resulting in such des16 ignation contained an untrue statement of ma17 terial fact. 

18 ‘‘(3) NOTICE TO PUBLIC.—The Secretary shall 

19 provide public notice of the designation of a drug 

20 under paragraph (1). 

21 ‘‘(b) EXTENSION.— 

22 ‘‘(1) IN GENERAL.—If the Secretary designates 

23 a drug as a drug approved for a new indication for 

24 a rare disease or condition, as described in sub25 section (a)(1)— 

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‘‘(A)(i) the 4-, 5-, and 71 1 ⁄2-year periods de2 scribed in subsections (c)(3)(E)(ii) and 

3 (j)(5)(F)(ii) of section 505, the 3-year periods 

4 described in clauses (iii) and (iv) of subsection 

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

6 (j)(5)(F) of section 505, and the 7-year period 

7 described in section 527, as applicable, shall be 

8 extended by 6 months; or 

9 ‘‘(ii) the 4- and 12-year periods described 

10 in subparagraphs (A) and (B) of section 

11 351(k)(7) of the Public Health Service Act and 

12 the 7-year period described in section 527, as 

13 applicable, shall be extended by 6 months; and 

14 ‘‘(B)(i) if the drug is the subject of a listed 

15 patent for which a certification has been sub16 mitted under subsection (b)(2)(A)(ii) or 

17 (j)(2)(A)(vii)(II) of section 505 or a listed pat18 ent for which a certification has been submitted 

19 under subsection (b)(2)(A)(iii) or 

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

21 during which an application may not be ap22 proved under section 505(c)(3) or section 

23 505(j)(5)(B) shall be extended by a period of 6 

24 months after the date the patent expires (in25 cluding any patent extensions); or 

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1 ‘‘(ii) if the drug is the subject of a listed 

2 patent for which a certification has been sub3 mitted under subsection (b)(2)(A)(iv) or 

4 (j)(2)(A)(vii)(IV) of section 505, and in the pat5 ent infringement litigation resulting from the 

6 certification the court determines that the pat7 ent is valid and would be infringed, the period 

8 during which an application may not be ap9 proved under section 505(c)(3) or section 

10 505(j)(5)(B) shall be extended by a period of 6 

11 months after the date the patent expires (in12 cluding any patent extensions). 

13 ‘‘(2) RELATION TO PEDIATRIC AND QUALIFIED

14 INFECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any 

15 extension under paragraph (1) of a period shall be 

16 in addition to any extension of the periods under 

17 sections 505A and 505E of this Act and section 

18 351(m) of the Public Health Service Act, as applica19 ble, with respect to the drug. 

20 ‘‘(c) LIMITATIONS.—Any extension described in sub21 section (b)(1) shall not apply if the drug designated under 

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

23 operation of subsection (b)(1). 

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1 ‘‘(d) DEFINITION.—In this section, the term ‘rare 

2 disease or condition’ has the meaning given to such term 

3 in section 526(a)(2).’’. 

4 (b) APPLICATION.—Section 505G of the Federal 

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

6 (a), applies only with respect to a drug for which an appli7 cation or supplemental application described in subsection 

8 (a)(1)(B)(i) of such section 505G is first approved under 

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

10 351(a) of the Public Health Service Act (42 U.S.C. 

11 262(a)) on or after the date of the enactment of this Act. 

12 (c) CONFORMING AMENDMENTS.— 

13 (1) RELATION TO PEDIATRIC EXCLUSIVITY FOR

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

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

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

17 the following: 

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

19 APPROVED FOR A NEW INDICATION FOR A RARE DIS20 EASE OR CONDITION.—Notwithstanding the ref21 erences in paragraph (1) to the lengths of the exclu22 sivity periods after application of pediatric exclu23 sivity, the 6-month extensions described in para24 graph (1) shall be in addition to any extensions 

25 under section 505G.’’; and 

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1 (B) in subsection (c), 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 paragraph (1) to the lengths of the exclu7 sivity periods after application of pediatric exclu8 sivity, the 6-month extensions described in para9 graph (1) shall be in addition to any extensions 

10 under section 505G.’’. 

11 (2) RELATION TO EXCLUSIVITY FOR NEW

12 QUALIFIED INFECTIOUS DISEASE PRODUCTS THAT

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

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

15 355f) is amended— 

16 (A) by amending the subsection heading to 

17 read as follows: ‘‘RELATION TO PEDIATRIC EX18 CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP19 PROVED FOR A NEW INDICATION FOR A RARE

20 DISEASE OR CONDITION.—’’; and 

21 (B) by striking ‘‘any extension of the pe22 riod under section 505A’’ and inserting ‘‘any 

23 extension of the periods under sections 505A 

24 and 505G, as applicable,’’. 

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1 (3) RELATION TO PEDIATRIC EXCLUSIVITY FOR

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

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

4 amended by adding at the end the following: 

5 ‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO6 LOGICAL PRODUCT APPROVED FOR A NEW INDICA7 TION FOR A RARE DISEASE OR CONDITION.—Not8 withstanding the references in paragraphs (2)(A), 

9 (2)(B), (3)(A), and (3)(B) to the lengths of the ex10 clusivity periods after application of pediatric exclu11 sivity, the 6-month extensions described in such 

12 paragraphs shall be in addition to any extensions 

13 under section 505G.’’. 

14 SEC. 3. ORPHAN DRUGS. 

15 (a) IN GENERAL.—Section 527 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 

17 (1) in subsection (a), in the matter following 

18 paragraph (2), by striking ‘‘such drug for such dis19 ease or condition’’ and inserting ‘‘the same drug for 

20 the same disease or condition’’; 

21 (2) in subsection (b)— 

22 (A) in the matter preceding paragraph (1), 

23 by striking ‘‘If an application’’ and all that fol24 lows through ‘‘such license if’’ and inserting 

25 ‘‘During the 7-year period described in submstockstill on DSK30JT082PROD with BILLS

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1 section (a) for an approved application under 

2 section 505 or license under section 351 of the 

3 Public Health Service Act, the Secretary may 

4 approve an application or issue a license for a 

5 drug that is otherwise the same, as determined 

6 by the Secretary, as the already approved drug 

7 for the same rare disease or condition if’’; 

8 (B) in paragraph (1), by striking ‘‘notice’’ 

9 and all that follows through ‘‘assure’’ and in10 serting ‘‘of exclusive approval or licensure no11 tice and opportunity for the submission of 

12 views, that during such period the holder of the 

13 exclusive approval or licensure cannot ensure’’; 

14 and 

15 (C) in paragraph (2), by striking ‘‘such 

16 holder provides’’ and inserting ‘‘the holder pro17 vides’’; and 

18 (3) by adding at the end the following: 

19 ‘‘(c) CONDITION OF CLINICAL SUPERIORITY.— 

20 ‘‘(1) IN GENERAL.—If a sponsor of a drug that 

21 is designated under section 526 and is otherwise the 

22 same, as determined by the Secretary, as an already 

23 approved or licensed drug is seeking exclusive ap24 proval or exclusive licensure described in subsection 

25 (a) for the same rare disease or condition as the almstockstill on DSK30JT082PROD with BILLS

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1 ready approved drug, the Secretary shall require 

2 such sponsor, as a condition of such exclusive ap3 proval or licensure, to demonstrate that such drug is 

4 clinically superior to any already approved or li5 censed drug that is the same drug. 

6 ‘‘(2) DEFINITION.—For purposes of paragraph 

7 (1), the term ‘clinically superior’ with respect to a 

8 drug means that the drug provides a significant 

9 therapeutic advantage over and above an already ap10 proved or licensed drug in terms of greater efficacy, 

11 greater safety, or by providing a major contribution 

12 to patient care. 

13 ‘‘(d) REGULATIONS.—The Secretary may promulgate 

14 regulations for the implementation of subsection (c). Be15 ginning on the date of enactment of the Orphan Products 

16 Extension Now Accelerating Cures and Treatments Act 

17 of 2017, until such time as the Secretary promulgates reg18 ulations in accordance with this subsection, the Secretary 

19 may apply any definitions set forth in regulations that 

20 were promulgated prior to such date of enactment, to the 

21 extent such definitions are not inconsistent with the terms 

22 of this section, as amended by such Act. 

23 ‘‘(e) DEMONSTRATION OF CLINICAL SUPERIORITY

24 STANDARD.—To assist sponsors in demonstrating clinical 

25 superiority as described in subsection (c), the Secretary— 

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1 ‘‘(1) upon the designation of any drug under 

2 section 526, shall notify the sponsor of such drug in 

3 writing of the basis for the designation, including, as 

4 applicable, any plausible hypothesis offered by the 

5 sponsor and relied upon by the Secretary that the 

6 drug is clinically superior to a previously approved 

7 drug; and 

8 ‘‘(2) upon granting exclusive approval or licen9 sure under subsection (a) on the basis of a dem10 onstration of clinical superiority as described in sub11 section (c), shall publish a summary of the clinical 

12 superiority findings.’’. 

13 (b) RULE OF CONSTRUCTION.—Nothing in the 

14 amendments made by subsection (a) shall affect any deter15 mination under sections 526 and 527 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made 

17 prior to the date of enactment of the Orphan Products 

18 Extension Now Accelerating Cures and Treatments Act 

19 of 2017. 

20 SEC. 4. PEDIATRIC INFORMATION ADDED TO LABELING. 

21 Section 505A(o) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 355a(o)) is amended— 

23 (1) in the subsection heading, by striking 

24 ‘‘UNDER SECTION 505(j)’’; 

25 (2) in paragraph (1)— 

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1 (A) by striking ‘‘under section 505(j)’’ and 

2 inserting ‘‘under subsection (b)(2) or (j) of sec3 tion 505’’; and 

4 (B) by striking ‘‘or by exclusivity under 

5 clause (iii) or (iv) of section 505(j)(5)(F)’’ and 

6 inserting ‘‘, or by exclusivity under clause (iii) 

7 or (iv) of section 505(j)(5)(F), clauses (iii) and 

8 (iv) of section 505(c)(3)(E), or section 527(a), 

9 or by an extension of such exclusivity under this 

10 section or section 505E’’; 

11 (3) in paragraph (2), in the matter preceding 

12 subparagraph (A)— 

13 (A) by inserting ‘‘clauses (iii) and (iv) of 

14 section 505(c)(3)(E), or section 527,’’ after 

15 ‘‘section 505(j)(5)(F),’’; and 

16 (B) by striking ‘‘drug approved under sec17 tion 505(j)’’ and inserting ‘‘drug approved pur18 suant to an application submitted under sub19 section (b)(2) or (j) of section 505’’; and 

20 (4) by amending paragraph (3) to read as fol21 lows: 

22 ‘‘(3) PRESERVATION OF PEDIATRIC EXCLU23 SIVITY AND OTHER PROVISIONS.—This subsection 

24 does not affect— 

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1 ‘‘(A) the availability or scope of exclusivity 

2 under— 

3 ‘‘(i) this section; 

4 ‘‘(ii) section 505 for pediatric formu5 lations; or 

6 ‘‘(iii) section 527; 

7 ‘‘(B) the question of the eligibility for ap8 proval of any application under subsection 

9 (b)(2) or (j) of section 505 that omits any other 

10 conditions of approval entitled to exclusivity 

11 under— 

12 ‘‘(i) clause (iii) or (iv) of section 

13 505(j)(5)(F); 

14 ‘‘(ii) clause (iii) or (iv) of section 

15 505(c)(3)(E); or 

16 ‘‘(iii) section 527; or 

17 ‘‘(C) except as expressly provided in para18 graphs (1) and (2), the operation of section 505 

19 or section 527.’’. 

Æ 

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