Improved Access to Affordable Medications Act

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. 1. Short title This Act may be cited as the Improved Access to Affordable Medications Act 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 (1) in subsection (a)— (A) in paragraph (1)(C)— (i) by inserting or contractual terms additional conditions (ii) by inserting by the license holder covered product (B) in paragraph (2)(A)(iii), by striking including any device 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 (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 covered product (F) in paragraph (11), as so redesignated— (i) in subparagraph (A), in the matter preceding clause (i), by inserting , at any time, conduct testing (ii) in subparagraph (B), by inserting , at any time, 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— 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— (ii) in subclause (II), by inserting or by a designated delivery service (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 (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. .

Summary: Improved Access to Affordable Medications Act This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development. Under current law, brand-name drug manufacturers must provide sufficient quantities of their products on commercially reasonable, market-based terms to generic drug manufacturers upon request for purposes of generic drug development. Brand-name drug manufacturers are subject to civil actions if they fail to do so. The bill modifies provisions relating to this requirement and the criteria needed for related civil actions, such as specifying that generic drug manufacturers may use certain delivery services to make their requests. Additionally, under current law, generic drug manufacturers must obtain authorization from the Food and Drug Administration (FDA) in order to request sufficient quantities of brand-name drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use (ETASU). The bill requires the FDA to approve an authorization request within 60 days (rather than 120 days), if testing and development does not involve human clinical trials. (The FDA sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through ETASU, such as special requirements for pharmacies that dispense the drug.) The bill also requires brand-name drug manufacturers to post their policies on evaluating and responding to requests from generic drug manufacturers for their products, including relevant contact information and procedures.