IIB 

116TH CONGRESS 

1ST SESSION H. R. 1520 

IN THE SENATE OF THE UNITED STATES 

MAY 9, 2019 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To amend the Public Health Service Act to provide for 

the publication of a list of licensed biological products, 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Purple Book Con3 tinuity Act of 2019’’. 

4 SEC. 2. PUBLIC LISTING. 

5 Section 351(k) of the Public Health Service Act (42 

6 U.S.C. 262(k)) is amended by adding at the end the fol7 lowing: 

8 ‘‘(9) PUBLIC LISTING.— 

9 ‘‘(A) IN GENERAL.— 

10 ‘‘(i) INITIAL PUBLICATION.—Not later 

11 than 180 days after the date of enactment 

12 of the Purple Book Continuity Act of 

13 2019, the Secretary shall publish and 

14 make available to the public in a search15 able, electronic format— 

16 ‘‘(I) a list in alphabetical order of 

17 the nonproprietary or proper name of 

18 each biological product for which a 

19 biologics license under subsection (a) 

20 or this subsection is in effect, or that 

21 has been deemed to be licensed under 

22 this section pursuant to section 

23 7002(e)(4) of the Biologics Price 

24 Competition and Innovation Act of 

25 2009, as of such date of enactment; 


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1 ‘‘(II) the date of approval of the 

2 marketing application and the applica3 tion number; and 

4 ‘‘(III) the marketing or licensure 

5 status of the biological product for 

6 which a biologics license under sub7 section (a) or this subsection is in ef8 fect or that has been deemed to be li9 censed under this section pursuant to 

10 section 7002(e)(4) of the Biologics 

11 Price Competition and Innovation Act 

12 of 2009. 

13 ‘‘(ii) REVISIONS.—Every 30 days 

14 after the publication of the first list under 

15 clause (i), the Secretary shall revise the list 

16 to include each biological product which 

17 has been licensed under subsection (a) or 

18 this subsection during the 30-day period. 

19 ‘‘(iii) PATENT INFORMATION.—Not 

20 later than 30 days after a list of patents 

21 under subsection (l)(3)(A), or a supple22 ment to such list under subsection (l)(7), 

23 has been provided by the reference product 

24 sponsor to the subsection (k) applicant re25 specting a biological product included on 


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1 the list published under this subparagraph, 

2 the reference product sponsor shall provide 

3 such list of patents (or supplement there4 to) and their corresponding expiry dates to 

5 the Secretary, and the Secretary shall, in 

6 revisions made under clause (ii), include 

7 such information for such biological prod8 uct. Within 30 days of providing any sub9 sequent or supplemental list of patents to 

10 any subsequent subsection (k) applicant 

11 under subsection (l)(3)(A) or (l)(7), the 

12 reference product sponsor shall update the 

13 information provided to the Secretary 

14 under this clause with any additional pat15 ents from such subsequent or supplemental 

16 list and their corresponding expiry dates. 

17 ‘‘(iv) LISTING OF EXCLUSIVITIES.— 

18 For each biological product included on the 

19 list published under this subparagraph, the 

20 Secretary shall specify each exclusivity pe21 riod that is applicable and has not con22 cluded under paragraph (6) or paragraph 

23 (7). 

24 ‘‘(B) WITHDRAWAL OR SUSPENSION OF LI25 CENSURE.—If the licensing of a biological prodVerDate Sep 11 2014 20:36 May 09, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1520.RFS H1520

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1 uct was withdrawn or suspended for safety, pu2 rity, or potency reasons, it may not be pub3 lished in the list under subparagraph (A). If the 

4 withdrawal or suspension occurred after its 

5 publication in such list, the reference product 

6 sponsor shall notify the Secretary that— 

7 ‘‘(i) the biological product shall be im8 mediately removed from such list— 

9 ‘‘(I) for the same period as the 

10 withdrawal or suspension; or 

11 ‘‘(II) if the biological product has 

12 been withdrawn from sale, for the pe13 riod of withdrawal from sale or, if ear14 lier, the period ending on the date the 

15 Secretary determines that the with16 drawal from sale is not for safety, pu17 rity, or potency reasons; and 

18 ‘‘(ii) a notice of the removal shall be 

19 published in the Federal Register.’’. 

20 SEC. 3. REVIEW AND REPORT ON TYPES OF INFORMATION 

21 TO BE LISTED. 

22 Not later than 3 years after the date of enactment 

23 of this Act, the Secretary of Health and Human Services 

24 shall— 


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1 (1) solicit public comment regarding the type of 

2 information, if any, that should be added to or re3 moved from the list required by paragraph (9) of 

4 section 351(k) of the Public Health Service Act (42 

5 U.S.C. 262(k)), as added by section 2; and 

6 (2) transmit to Congress an evaluation of such 

7 comments, including any recommendations about the 

8 types of information that should be added to or re9 moved from the list. 

Passed the House of Representatives May 8, 2019. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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