I 

116TH CONGRESS 

1ST SESSION H. R. 1520 

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 

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. 

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 Con5 tinuity 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.— 


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1 ‘‘(A) IN GENERAL.— 

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

3 than 60 days after the date of enactment 

4 of the Purple Book Continuity Act of 

5 2019, the Secretary shall publish and 

6 make available to the public electroni7 cally— 

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

9 the official and proprietary name of 

10 each biological product for which a 

11 biologics license under subsection (a) 

12 or this subsection is in effect as of 

13 such date of enactment; 

14 ‘‘(II) the date of licensing if the 

15 biological product is licensed after 

16 1981 and the number of the applica17 tion which was approved; and 

18 ‘‘(III) whether in vitro or in vivo 

19 bioequivalence studies, or both such 

20 studies, are required for applications 

21 filed under this subsection which will 

22 refer to the biological product pub23 lished. 

24 ‘‘(ii) REVISIONS.—Every 30 days 

25 after the publication of the first list under 


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

2 to include each biological product which 

3 has been licensed under subsection (a) or 

4 this subsection during the 30-day period. 

5 ‘‘(iii) PATENT INFORMATION.—When 

6 patent information has been provided by 

7 the reference product sponsor to the sub8 section (k) applicant respecting a biological 

9 product included on the list published 

10 under this subparagraph, the Secretary 

11 shall, in revisions made under clause (ii), 

12 include such information for such biologi13 cal product. 

14 ‘‘(B) DATE OF PUBLICATION.—A biological 

15 product for which a license is in effect under 

16 subsection (a) or this subsection shall, for pur17 poses of this subsection, be considered to have 

18 been published under subparagraph (A) on the 

19 later of— 

20 ‘‘(i) the date of its licensing; or 

21 ‘‘(ii) the date of its publication in the 

22 list that— 

23 ‘‘(I) was published under this 

24 section before the initial publication of 

25 the list under subparagraph (A); and 


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1 ‘‘(II) was equivalent to the list 

2 published under section 505(j)(7) of 

3 the Federal Food, Drug, and Cos4 metic Act and comprised of patents 

5 associated with applications filed 

6 under subsection (a) of this section or 

7 under this subsection. 

8 ‘‘(C) WITHDRAWAL OR SUSPENSION OF LI9 CENSURE.—If the licensing of a biological prod10 uct was withdrawn or suspended for safety, pu11 rity, or potency reasons, it may not be pub12 lished in the list under subparagraph (A). If the 

13 withdrawal or suspension occurred after its 

14 publication in such list— 

15 ‘‘(i) it shall be immediately removed 

16 from such list— 

17 ‘‘(I) for the same period as the 

18 withdrawal or suspension; or 

19 ‘‘(II) if the listed drug has been 

20 withdrawn from sale, for the period of 

21 withdrawal from sale or, if earlier, the 

22 period ending on the date the Sec23 retary determines that the withdrawal 

24 from sale is not for safety, purity, or 

25 potency reasons; and 


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

2 published in the Federal Register.’’. 

3 SEC. 3. REVIEW AND REPORT ON TYPES OF BIOLOGICAL 

4 PRODUCT PATENTS TO BE LISTED. 

5 Not later than 3 years after the date of enactment 

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

7 shall— 

8 (1) complete a review of, and formulate rec9 ommendations on, the types of biological product 

10 patents that should be included in or removed from 

11 the list required by paragraph (9) of section 351(k) 

12 of the Public Health Service Act (42 U.S.C. 262(k)), 

13 as added by section 2; and 

14 (2) report such recommendations to the Con15 gress. 

Æ 


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