[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1520 Engrossed Amendment Senate (EAS)]
<DOC>
In the Senate of the United States,
December 10, 2020.
Resolved, That the bill from the House of Representatives (H.R.
1520) entitled ``An Act to amend the Public Health Service Act to
provide for the publication of a list of licensed biological products,
and for other purposes.'', do pass with the following
AMENDMENT:
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
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.
Attest:
Secretary.
116th CONGRESS
2d Session
H.R. 1520
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AMENDMENT