Title II — Increasing Access to Drugs and Biosimilar Products

“524B. Expedited development and priority review for generic complex drug products

“(a) Establishment of program—The Secretary shall establish a program to expedite the development of, and provide priority review under section 505(j) for, generic complex drug products.

“(b) Request for designation—A sponsor of a generic complex drug product may request that the Secretary designate such product for expedited development and priority review under this section.

“(c) Designation process

“(1) In general—Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the product that is the subject of the request meets the criteria under subsection (e) to be considered a generic complex drug product. If the Secretary determines that the product meets the criteria, the Secretary shall designate the product for expedited development and priority review.

“(2) Review—Review of a request under subsection (b) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration.

“(3) Withdrawal—The Secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection (e) no longer applying because of the subsequent clearance or approval of any other product.

“(d) Expedited development and priority review Guidance

“(1) Content—Not later than December 31, 2021, the Secretary shall issue guidance on the implementation of this section. Such guidance shall—

“(A) set forth the process by which a person may seek a designation under subsection (c);

“(B) provide a template for requests under subsection (b);

“(C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and

“(D) identify the criteria and processes the Secretary will use to expedite the development and review of products designated under this section.

“(2) Process—Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance.

“(e) Generic complex drug product defined—In this section, the term generic complex drug product means a product that represents a complex therapy that consists of or includes a drug for approval under section 505(j) and that—

“(1)

“(A) contains complex active ingredients (such as peptides, polymeric compounds, complex mixtures of active ingredients, and naturally sourced ingredients);

“(B) is composed of complex formulations (such as liposomes or colloids);

“(C) requires a complex route of delivery (such as locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels); or

“(D) involves a complex dosage form (such as transdermals, metered dose inhalers, or extended release injectables);

“(2) presents as a complex drug-device combination product (such as auto injectors or metered dose inhalers); or

“(3) is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section 505(j).”

“(4) Unmet medical need—For purposes of paragraph (1), a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than 3 available drugs exist for the treatment of such disease or condition.”

“(4) Products authorized for marketing in European Union—In considering whether to license a biological product under this subsection or subsection (k), the Secretary may expedite the licensing process if the biological product has been authorized for marketing by the European Medicines Agency and such authorization remains in effect.”