[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1520 Engrossed in House (EH)]
<DOC>
116th CONGRESS
1st Session
H. R. 1520
_______________________________________________________________________
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.
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
180 days after the date of enactment of the
Purple Book Continuity Act of 2019, the
Secretary shall publish and make available to
the public in a searchable, electronic format--
``(I) a list in alphabetical order
of the nonproprietary or proper name of
each biological product for which a
biologics license under subsection (a)
or this subsection is in effect, or
that has been deemed to be licensed
under this section pursuant to section
7002(e)(4) of the Biologics Price
Competition and Innovation Act of 2009,
as of such date of enactment;
``(II) the date of approval of the
marketing application and the
application number; and
``(III) the marketing or licensure
status of the biological product for
which a biologics license under
subsection (a) or this subsection is in
effect or that has been deemed to be
licensed under this section pursuant to
section 7002(e)(4) of the Biologics
Price Competition and Innovation Act of
2009.
``(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.--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
that is applicable and has not concluded under
paragraph (6) or paragraph (7).
``(B) 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, the reference product sponsor
shall notify the Secretary that--
``(i) the biological product shall be
immediately removed from such list--
``(I) for the same period as the
withdrawal or suspension; or
``(II) if the biological product
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 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
section 2; 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.
Passed the House of Representatives May 8, 2019.
Attest:
Clerk.
116th CONGRESS
1st Session
H. R. 1520
_______________________________________________________________________
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.