Improved Access to Affordable Medications Act

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1120 Introduced in Senate (IS)]

&lt;DOC&gt;






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.''.
                                 &lt;all&gt;
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