[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1520 Introduced in House (IH)]
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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.
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IN THE HOUSE OF REPRESENTATIVES
March 5, 2019
Ms. Eshoo introduced the following bill; which was referred to the
Committee on Energy and Commerce
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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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Purple Book Continuity 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 following:
``(9) Public listing.--
``(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 electronically--
``(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 application
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
published.
``(ii) Revisions.--Every 30 days after the
publication of the first list under 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 subsection (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
biological product.
``(B) Date of publication.--A biological product
for which a license is in effect under subsection (a)
or this subsection shall, for purposes 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
``(II) was equivalent to the list
published under section 505(j)(7) of
the Federal Food, Drug, and Cosmetic
Act and comprised of patents associated
with applications filed under
subsection (a) of this section or under
this subsection.
``(C) Withdrawal or suspension of licensure.--If
the licensing of a biological product was withdrawn or
suspended for safety, purity, or potency reasons, it
may not be published 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
Secretary determines that the
withdrawal from sale is not for safety,
purity, or potency reasons; and
``(ii) a notice of the removal shall be
published in the Federal Register.''.
SEC. 3. REVIEW AND REPORT ON TYPES OF BIOLOGICAL PRODUCT PATENTS TO BE
LISTED.
Not later than 3 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall--
(1) complete a review of, and formulate recommendations on,
the types of biological product patents that should be included
in or removed from the list required by paragraph (9) of
section 351(k) of the Public Health Service Act (42 U.S.C.
262(k)), as added by section 2; and
(2) report such recommendations to the Congress.
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