[Congressional Record Volume 166, Number 209 (Thursday, December 10, 2020)]
[Senate]
[Pages S7396-S7397]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PURPLE BOOK CONTINUITY ACT OF 2019.
Mr. CORNYN. Mr. President, I ask unanimous consent that the Committee
on Health, Education, Labor, and Pensions be discharged from further
consideration of H.R. 1520 and the Senate proceed to its immediate
consideration.
The PRESIDING OFFICER. Without objection, it is so ordered.
The clerk will report the bill by title.
The legislative clerk read as follows:
A bill (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.
There being no objection, the committee was discharged and the Senate
proceeded to consider the bill.
Mr. CORNYN. Mr. President, I ask unanimous consent that the Alexander
substitute amendment at the desk be agreed to; that the bill, as
amended, be considered read a third time and passed; and that the
motions to reconsider be considered made and laid upon the table.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment (No. 2699) was agreed, to as follows
(Purpose: In the nature of a substitute)
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
The Act may be cited as the ``Purple Book Continuity Act of
2020''.
SEC. 2. BIOLOGICAL PRODUCT PATENT TRANSPARENCY.
(a) In General.--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 180 days after
the date of enactment of the Purple Book Continuity Act of
2020, the Secretary shall publish and make available to the
public in a searchable, electronic format--
``(I) a list of each biological product, by nonproprietary
name (proper name), for which, as of such date of enactment,
a biologics license under subsection (a) or this subsection
is in effect, or that, as of such date of enactment, is
deemed to be licensed under this section pursuant to section
7002(e)(4) of the Biologics Price Competition and Innovation
Act of 2009;
``(II) the date of licensure of the marketing application
and the application number; and
``(III) with respect to each biological product described
in subclause (I), the licensure status, and, as available,
the marketing status.
``(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 or deemed licensed under this section pursuant
to section 7002(e)(4) of the Biologics Price Competition and
Innovation Act of 2009.
``(iii) Patent information.--Not later than 30 days after a
list of patents under subsection (l)(3)(A), or a supplement
to such list under subsection (l)(7), 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 reference product
sponsor shall provide such list of patents (or supplement
thereto) and their corresponding expiry dates to the
Secretary, and the Secretary shall, in revisions made under
clause (ii), include such information for such biological
product. Within 30 days of providing any subsequent or
supplemental list of patents to any subsequent subsection (k)
applicant under subsection (l)(3)(A) or (l)(7), the reference
product sponsor shall update the information provided to the
Secretary under this clause with any additional patents from
such subsequent or supplemental list and their corresponding
expiry dates.
``(iv) Listing of exclusivities.--For each biological
product included on the list published under this
subparagraph, the Secretary shall specify each exclusivity
period under paragraph (6) or paragraph (7) for which the
Secretary has determined such biological product to be
eligible and that has not concluded.
``(B) Revocation or suspension of license.--If the license
of a biological product is determined by the Secretary to
have been revoked or suspended for safety, purity, or potency
reasons, it may not be published in
[[Page S7397]]
the list under subparagraph (A). If such revocation or
suspension occurred after inclusion of such biological
product in the list published under subparagraph (A), the
reference product sponsor shall notify the Secretary that--
``(i) the biological product shall be immediately removed
from such list for the same period as the revocation or
suspension; and
``(ii) a notice of the removal shall be published in the
Federal Register.''.
(b) Review and Report on Types of Information 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) solicit public comment regarding the type of
information, if any, that should be added to 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
subsection (a); and
(2) transmit to Congress an evaluation of such comments,
including any recommendations about the types of information
that should be added to or removed from the list.
The amendment was ordered to be engrossed and the bill to be read a
third time.
The bill was read the third time.
The bill (H.R. 1520), as amended, was passed.
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