[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1120 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 1120
To improve the actions available to eligible product developers in the
event of delays in receiving covered product for purposes of generic
drug or biosimilar biological product development.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 30, 2023
Ms. Hassan (for herself and Mr. Braun) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve the actions available to eligible product developers in the
event of delays in receiving covered product for purposes of generic
drug or biosimilar biological product development.
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 ``Improved Access to Affordable
Medications Act''.
SEC. 2. AMENDMENTS TO ACTIONS FOR DELAYS OF GENERIC DRUGS AND
BIOSIMILAR BIOLOGICAL PRODUCTS.
Section 610 of division N of the Further Consolidated
Appropriations Act, 2020 (Public Law 116-94; 21 U.S.C. 355-2) is
amended--
(1) in subsection (a)--
(A) in paragraph (1)(C)--
(i) by inserting ``or contractual terms''
after ``additional conditions''; and
(ii) by inserting ``by the license holder''
after ``covered product'';
(B) in paragraph (2)(A)(iii), by striking
``including any device'' and inserting ``including any
packaging, device, or accessory'';
(C) by redesignating paragraphs (3) through (10) as
paragraphs (4) through (11), respectively;
(D) by inserting after paragraph (3) the following:
``(4) the term `designated delivery service' means any
delivery service provided by a trade or business that the
Secretary determines--
``(A) is available to the general public throughout
the United States;
``(B) records electronically to its database, kept
in the regular course of its business, or marks on the
cover in which any item referred to in this section is
to be delivered, the date on which such item was given
to such trade or business for delivery; and
``(C) provides overnight or 2-day delivery service
throughout the United States;'';
(E) in paragraph (6), as so redesignated, by
inserting ``including the parent company of such
holder'' after ``covered product''; and
(F) in paragraph (11), as so redesignated--
(i) in subparagraph (A), in the matter
preceding clause (i), by inserting ``, at any
time,'' after ``conduct testing''; and
(ii) in subparagraph (B), by inserting ``,
at any time,'' after ``fulfill'';
(2) in subsection (b)(2)--
(A) in subparagraph (A)(iii)--
(i) in the matter preceding subclause (I),
by striking ``a written request to purchase
sufficient quantities of the covered product to
the license holder, and such request--'' and
inserting ``one or more written requests to
purchase sufficient quantities of the covered
product to the license holder for the relevant
stage of development, and each such request--
''; and
(ii) in subclause (II), by inserting ``or
by a designated delivery service'' before the
semicolon at the end; and
(B) in subparagraph (B), by amending clause (ii) to
read as follows:
``(ii) Authorization.--The Secretary shall,
by written notice, authorize the eligible
product developer to obtain sufficient
quantities of an individual covered product
subject to a REMS with ETASU for purposes of
development and testing--
``(I) in the case of development
and testing that does not involve human
clinical trials, not later than 60 days
after the date on which a request under
clause (i) is received, if the eligible
product developer has agreed to comply
with any conditions the Secretary
determines necessary; or
``(II) in the case of development
and testing that involves human
clinical trials, not later than 120
days after the date on which a request
under clause (i) is received, if the
eligible product developer has--
``(aa)(AA) submitted
protocols, informed consent
documents, and informational
materials for testing that
include protections that
provide safety protections
comparable to those provided by
the REMS for the covered
product; or
``(BB) otherwise satisfied
the Secretary that such
protections will be provided;
and
``(bb) met any other
requirements the Secretary may
establish.''; and
(3) by adding at the end the following:
``(h) Samples Access Policy.--Not later than 45 days after the date
of approval of a covered product, or, in the case of a covered product
approved before the date of enactment of the Improved Access to
Affordable Medications Act, not later than 45 days after such date of
enactment, each license holder of a covered product shall make
available its policy on evaluating and responding to requests submitted
under subsection (b)(2)(A). Such policy shall--
``(1) be made public and readily available, such as by
posting such policy on a publicly available website; and
``(2) shall include--
``(A) contact information for the license holder to
facilitate communication about written requests
described in subsection (b)(2)(A)(iii);
``(B) procedures for making such requests;
``(C) the address to which such requests should be
sent;
``(D) the official license holder for each marketed
product; and
``(E) the named corporate officer who is
responsible for receiving such requests.''.
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