IB 

Union Calendar No. 26 

116TH CONGRESS 

1ST SESSION H. R. 1520 

[Report No. 116–48] 

To amend the Public Health Service Act to provide for the publication 

of a list of licensed biological products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2019 

Ms. ESHOO introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

MAY 3, 2019 

Additional sponsors: Mrs. CRAIG, Mrs. DINGELL, Mr. RUIZ, Mr. RUSH, Mr. 

PALLONE, Mr. KENNEDY, Mr. BURGESS, Ms. MATSUI, Ms. CLARKE of 

New York, Mr. VAN DREW, Mr. WALDEN, and Ms. MUCARSEL-POWELL

MAY 3, 2019 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on March 5, 2019] 


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•HR 1520 RH

A BILL 

To amend the Public Health Service Act to provide for 

the publication of a list of licensed biological products, 

and for other purposes. 


pamtmann on DSKBFK8HB2PROD with BILLS
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•HR 1520 RH

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 ‘‘Purple Book Continuity 

5 Act of 2019’’. 

6 SEC. 2. PUBLIC LISTING. 

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

8 U.S.C. 262(k)) is amended by adding at the end the fol9 lowing: 

10 ‘‘(9) PUBLIC LISTING.— 

11 ‘‘(A) IN GENERAL.— 

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

13 than 180 days after the date of enactment 

14 of the Purple Book Continuity Act of 2019, 

15 the Secretary shall publish and make avail16 able to the public in a searchable, electronic 

17 format— 

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

19 the nonproprietary or proper name of 

20 each biological product for which a bio21 logics license under subsection (a) or 

22 this subsection is in effect, or that has 

23 been deemed to be licensed under this 

24 section pursuant to section 7002(e)(4) 

25 of the Biologics Price Competition and 


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•HR 1520 RH

1 Innovation Act of 2009, as of such date 

2 of enactment; 

3 ‘‘(II) the date of approval of the 

4 marketing application and the appli5 cation number; and 

6 ‘‘(III) the marketing or licensure 

7 status of the biological product for 

8 which a biologics license under sub9 section (a) or this subsection is in ef10 fect or that has been deemed to be li11 censed under this section pursuant to 

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

13 Price Competition and Innovation Act 

14 of 2009. 

15 ‘‘(ii) REVISIONS.—Every 30 days after 

16 the publication of the first list under clause 

17 (i), the Secretary shall revise the list to in18 clude each biological product which has been 

19 licensed under subsection (a) or this sub20 section during the 30-day period. 

21 ‘‘(iii) PATENT INFORMATION.—Not 

22 later than 30 days after a list of patents 

23 under subsection (l)(3)(A), or a supplement 

24 to such list under subsection (l)(7), has been 

25 provided by the reference product sponsor to 


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•HR 1520 RH

1 the subsection (k) applicant respecting a bi2 ological product included on the list pub3 lished under this subparagraph, the ref4 erence product sponsor shall provide such 

5 list of patents (or supplement thereto) and 

6 their corresponding expiry dates to the Sec7 retary, and the Secretary shall, in revisions 

8 made under clause (ii), include such infor9 mation for such biological product. Within 

10 30 days of providing any subsequent or 

11 supplemental list of patents to any subse12 quent subsection (k) applicant under sub13 section (l)(3)(A) or (l)(7), the reference 

14 product sponsor shall update the informa15 tion provided to the Secretary under this 

16 clause with any additional patents from 

17 such subsequent or supplemental list and 

18 their corresponding expiry dates. 

19 ‘‘(iv) LISTING OF EXCLUSIVITIES.—For 

20 each biological product included on the list 

21 published under this subparagraph, the Sec22 retary shall specify each exclusivity period 

23 that is applicable and has not concluded 

24 under paragraph (6) or paragraph (7). 


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•HR 1520 RH

1 ‘‘(B) WITHDRAWAL OR SUSPENSION OF LI2 CENSURE.—If the licensing of a biological prod3 uct was withdrawn or suspended for safety, pu4 rity, or potency reasons, it may not be published 

5 in the list under subparagraph (A). If the with6 drawal or suspension occurred after its publica7 tion in such list, the reference product sponsor 

8 shall notify the Secretary that— 

9 ‘‘(i) the biological product shall be im10 mediately removed from such list— 

11 ‘‘(I) for the same period as the 

12 withdrawal or suspension; or 

13 ‘‘(II) if the biological product has 

14 been withdrawn from sale, for the pe15 riod of withdrawal from sale or, if ear16 lier, the period ending on the date the 

17 Secretary determines that the with18 drawal from sale is not for safety, pu19 rity, or potency reasons; and 

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

21 published in the Federal Register.’’. 


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•HR 1520 RH

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

2 TO BE LISTED. 

3 Not later than 3 years after the date of enactment of 

4 this Act, the Secretary of Health and Human Services 

5 shall— 

6 (1) solicit public comment regarding the type of 

7 information, if any, that should be added to or re8 moved from the list required by paragraph (9) of sec9 tion 351(k) of the Public Health Service Act (42 

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

11 (2) transmit to Congress an evaluation of such 

12 comments, including any recommendations about the 

13 types of information that should be added to or re14 moved from the list. 


pamtmann on DSKBFK8HB2PROD with BILLS
Union Calendar No. 26 

116TH CONGRESS 

1ST SESSION H. R. 1520 

[Report No. 116–48] 

A BILL 

To amend the Public Health Service Act to provide 

products, and for other purposes. for the publication of a list of licensed biological 

MAY 3, 2019 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


pamtmann on DSKBFK8HB2PROD with BILLS