Federal

Improved Access to Affordable Medications Act

Source: Congress.gov · 1,133 words in original text

What This Bill Does

This bill improves options available to companies developing generic drugs and biosimilar biological products (copies of brand-name biologic drugs) when they experience delays getting samples of the original drug for testing purposes. The bill modifies existing rules to make it easier for these developers to obtain the drugs they need and requires brand-name drug makers to publicly share their policies on providing samples. ##

Who It Affects

• Companies developing generic drugs and biosimilar biological products • Brand-name drug manufacturers (license holders) • The Secretary of Health and Human Services • The general public seeking access to affordable medications ##

Key Provisions

• Brand-name drug makers must publish their policies on how they evaluate and respond to sample requests within 45 days of drug approval, including contact information, request procedures, mailing addresses, and the name of the corporate officer responsible for handling requests (Sec. 2(h)) • The Secretary must authorize generic or biosimilar developers to obtain drug samples within 60 days for non-human testing or within 120 days for human clinical trials if the developer meets specified safety conditions (Sec. 2(b)(2)(B)(ii)) • Generic and biosimilar developers can make multiple requests for samples at different stages of development rather than just one request (Sec. 2(b)(2)(A)(iii)) • "Designated delivery service" means a delivery company available to the general public nationwide that provides overnight or 2-day delivery and electronically records delivery dates (Sec. 2(a)(D)) ##

What Changes

Drug manufacturers must make their sample-request policies publicly available online and provide specific contact details and procedures. Developers can now submit multiple requests at different development stages instead of one request. The Secretary has set timelines for approving sample access (60 or 120 days depending on testing type) rather than leaving this unspecified. ##

Important Definitions

• **"Covered product"** - Not fully defined in bill text beyond references to products subject to regulatory restrictions • **"License holder"** - The company holding approval to sell a drug product • **"REMS with ETASU"** - A risk management system with Elements to Assure Safe Use (a safety program that controls how certain drugs are distributed) • **"Designated delivery service"** - A delivery company available nationwide offering overnight or 2-day service that electronically tracks delivery dates ##

Effective Date

Not specified in bill text

II 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 devel- opers in the event of delays in receiving covered product for purposes of generic drug or biosimilar biological prod- uct development. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Improved Access to 4 Affordable Medications Act’’. 5 VerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1120 IS SEC. 2. AMENDMENTS TO ACTIONS FOR DELAYS OF GE- 1 NERIC DRUGS AND BIOSIMILAR BIOLOGICAL 2 PRODUCTS. 3 Section 610 of division N of the Further Consolidated 4 Appropriations Act, 2020 (Public Law 116–94; 21 U.S.C. 5 355–2) is amended— 6 (1) in subsection (a)— 7 (A) in paragraph (1)(C)— 8 (i) by inserting ‘‘or contractual 9 terms’’ after ‘‘additional conditions’’; and 10 (ii) by inserting ‘‘by the license hold- 11 er’’ after ‘‘covered product’’; 12 (B) in paragraph (2)(A)(iii), by striking 13 ‘‘including any device’’ and inserting ‘‘including 14 any packaging, device, or accessory’’; 15 (C) by redesignating paragraphs (3) 16 through (10) as paragraphs (4) through (11), 17 respectively; 18 (D) by inserting after paragraph (3) the 19 following: 20 ‘‘(4) the term ‘designated delivery service’ 21 means any delivery service provided by a trade or 22 business that the Secretary determines— 23 ‘‘(A) is available to the general public 24 throughout the United States; 25 VerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1120 IS ‘‘(B) records electronically to its database, 1 kept in the regular course of its business, or 2 marks on the cover in which any item referred 3 to in this section is to be delivered, the date on 4 which such item was given to such trade or 5 business for delivery; and 6 ‘‘(C) provides overnight or 2-day delivery 7 service throughout the United States;’’; 8 (E) in paragraph (6), as so redesignated, 9 by inserting ‘‘including the parent company of 10 such holder’’ after ‘‘covered product’’; and 11 (F) in paragraph (11), as so redesig- 12 nated— 13 (i) in subparagraph (A), in the matter 14 preceding clause (i), by inserting ‘‘, at any 15 time,’’ after ‘‘conduct testing’’; and 16 (ii) in subparagraph (B), by inserting 17 ‘‘, at any time,’’ after ‘‘fulfill’’; 18 (2) in subsection (b)(2)— 19 (A) in subparagraph (A)(iii)— 20 (i) in the matter preceding subclause 21 (I), by striking ‘‘a written request to pur- 22 chase sufficient quantities of the covered 23 product to the license holder, and such re- 24 quest—’’ and inserting ‘‘one or more writ- 25 VerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1120 IS ten requests to purchase sufficient quan- 1 tities of the covered product to the license 2 holder for the relevant stage of develop- 3 ment, and each such request—’’; and 4 (ii) in subclause (II), by inserting ‘‘or 5 by a designated delivery service’’ before the 6 semicolon at the end; and 7 (B) in subparagraph (B), by amending 8 clause (ii) to read as follows: 9 ‘‘(ii) AUTHORIZATION.—The Sec- 10 retary shall, by written notice, authorize 11 the eligible product developer to obtain suf- 12 ficient quantities of an individual covered 13 product subject to a REMS with ETASU 14 for purposes of development and testing— 15 ‘‘(I) in the case of development 16 and testing that does not involve 17 human clinical trials, not later than 18 60 days after the date on which a re- 19 quest under clause (i) is received, if 20 the eligible product developer has 21 agreed to comply with any conditions 22 the Secretary determines necessary; or 23 ‘‘(II) in the case of development 24 and testing that involves human clin- 25 VerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1120 IS ical trials, not later than 120 days 1 after the date on which a request 2 under clause (i) is received, if the eli- 3 gible product developer has— 4 ‘‘(aa)(AA) submitted proto- 5 cols, informed consent docu- 6 ments, and informational mate- 7 rials for testing that include pro- 8 tections that provide safety pro- 9 tections comparable to those pro- 10 vided by the REMS for the cov- 11 ered product; or 12 ‘‘(BB) otherwise satisfied 13 the Secretary that such protec- 14 tions will be provided; and 15 ‘‘(bb) met any other require- 16 ments the Secretary may estab- 17 lish.’’; and 18 (3) by adding at the end the following: 19 ‘‘(h) SAMPLES ACCESS POLICY.—Not later than 45 20 days after the date of approval of a covered product, or, 21 in the case of a covered product approved before the date 22 of enactment of the Improved Access to Affordable Medi- 23 cations Act, not later than 45 days after such date of en- 24 actment, each license holder of a covered product shall 25 VerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1120.IS S1120 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1120 IS make available its policy on evaluating and responding to 1 requests submitted under subsection (b)(2)(A). Such pol- 2 icy shall— 3 ‘‘(1) be made public and readily available, such 4 as by posting such policy on a publicly available 5 website; and 6 ‘‘(2) shall include— 7 ‘‘(A) contact information for the license 8 holder to facilitate communication about written 9 requests described in subsection (b)(2)(A)(iii); 10 ‘‘(B) procedures for making such requests; 11 ‘‘(C) the address to which such requests 12 should be sent; 13 ‘‘(D) the official license holder for each 14 marketed product; and 15 ‘‘(E) the named corporate officer who is 16 responsible for receiving such requests.’’. 17 Æ VerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S1120.IS S1120 kjohnson on DSK79L0C42PROD with BILLS

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