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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Purple Book Con-
tinuity Act of 2019’’. 
SEC. 2. PUBLIC LISTING. 
Section 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)) is amended by adding at the end the fol-
lowing: 
‘‘(9) PUBLIC LISTING.— 
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‘‘(A) IN GENERAL.— 
‘‘(i) INITIAL PUBLICATION.—Not later 
than 60 days after the date of enactment 
of the Purple Book Continuity Act of 
2019, the Secretary shall publish and 
make available to the public electroni-
cally— 
‘‘(I) a list in alphabetical order of 
the official and proprietary name of 
each biological product for which a 
biologics license under subsection (a) 
or this subsection is in effect as of 
such date of enactment; 
‘‘(II) the date of licensing if the 
biological product is licensed after 
1981 and the number of the applica-
tion which was approved; and 
‘‘(III) whether in vitro or in vivo 
bioequivalence studies, or both such 
studies, are required for applications 
filed under this subsection which will 
refer to the biological product pub-
lished. 
‘‘(ii) 
REVISIONS.—Every 
days 
after the publication of the first list under 
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clause (i), the Secretary shall revise the list 
to include each biological product which 
has been licensed under subsection (a) or 
this subsection during the 30-day period. 
‘‘(iii) PATENT
INFORMATION.—When 
patent information has been provided by 
the reference product sponsor to the sub-
section (k) applicant respecting a biological 
product included on the list published 
under this subparagraph, the Secretary 
shall, in revisions made under clause (ii), 
include such information for such biologi-
cal product. 
‘‘(B) DATE OF PUBLICATION.—A biological 
product for which a license is in effect under 
subsection (a) or this subsection shall, for pur-
poses of this subsection, be considered to have 
been published under subparagraph (A) on the 
later of— 
‘‘(i) the date of its licensing; or 
‘‘(ii) the date of its publication in the 
list that— 
‘‘(I) was published under this 
section before the initial publication of 
the list under subparagraph (A); and 
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‘‘(II) was equivalent to the list 
published under section 505(j)(7) of 
the Federal Food, Drug, and Cos-
metic Act and comprised of patents 
associated 
with 
applications 
filed 
under subsection (a) of this section or 
under this subsection. 
‘‘(C) WITHDRAWAL OR SUSPENSION OF LI-
CENSURE.—If the licensing of a biological prod-
uct was withdrawn or suspended for safety, pu-
rity, or potency reasons, it may not be pub-
lished in the list under subparagraph (A). If the 
withdrawal or suspension occurred after its 
publication in such list— 
‘‘(i) it shall be immediately removed 
from such list— 
‘‘(I) for the same period as the 
withdrawal or suspension; or 
‘‘(II) if the listed drug has been 
withdrawn from sale, for the period of 
withdrawal from sale or, if earlier, the 
period ending on the date the Sec-
retary determines that the withdrawal 
from sale is not for safety, purity, or 
potency reasons; and 
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