Sec. 506. Platform technologies
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Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506J of such Act ( 21 U.S.C. 356j ) the following: The Secretary shall establish a process for the designation of platform technologies that meet the criteria described in subsection (b). A platform technology incorporated within or utilized by a drug is eligible for designation as a designated platform technology under this section if— the platform technology is incorporated in, or utilized by, a drug approved under section 505 of this Act or a biological product licensed under section 351 of the Public Health Service Act; preliminary evidence submitted by the sponsor of the approved or licensed drug described in paragraph (1), or a sponsor that has been granted a right of reference to data submitted in the application for such drug, demonstrates that the platform technology has the potential to be incorporated in, or utilized by, more than one drug without an adverse effect on quality, manufacturing, or safety; and data or information submitted by the applicable person under paragraph
(2)indicates that incorporation or utilization of the platform technology has a reasonable likelihood to bring significant efficiencies to the drug development or manufacturing process and to the review processes. A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request. Not later than 60 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection (b). If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section 505(b) of this Act or section 351(a) of the Public Health Service Act for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate. If the Secretary determines that the platform technology does not meet the criteria under subsection (b), the Secretary shall include with the determination not to designate the technology a written description of the rationale for such determination. The Secretary may revoke a designation made under paragraph (2), if the Secretary determines that the designated platform technology no longer meets the criteria described in subsection (b). The Secretary shall communicate the determination to revoke a designation to the requesting sponsor in writing, including a description of the rationale for such determination. Nothing in this section shall prevent a product that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this Act or the Public Health Service Act. The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a designated platform technology, including— engaging in early interactions with the sponsor to discuss the use of the designated platform technology and what is known about such technology, including data previously submitted that is relevant to establishing, as applicable, safety or efficacy under section 505(b) of this Act or safety, purity, or potency under section 351(a) of the Public Health Service Act; providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug that proposes to use the designated platform technology to ensure that the development program designed to gather data necessary for approval or licensure is as efficient as practicable, which may include holding meetings with the sponsor and the review team throughout the development of the drug; and considering inspectional findings, including prior findings, related to the manufacture of a drug that incorporates or utilizes the designated platform technology. The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this Act and section 351(a) of the Public Health Service Act, allow the sponsor of an application under section 505(b) of this Act or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 564, in order to support approval, licensure, or authorization, to reference or rely upon data and information within such application or request that incorporates or utilizes the same or substantially similar platform technology designated under subsection (d), provided that— such data and information was submitted by the same sponsor, pursuant to the application for the drug with respect to which designation of the designated platform technology under subsection
(d)was granted; or the sponsor relying on such data and information received a right of reference to such data and information from the sponsor described in paragraph (1). A sponsor of one or more applications approved under section 505(b) of this Act or section 351(a) of the Public Health Service Act for a drug or biological product that incorporates or utilizes the same designated platform technology may submit a single supplemental application for the same proposed changes to the designated platform technology that is applicable to more than one drug or biological product that incorporates or utilizes such designated platform technology that may be cross referenced in other applications incorporating such change. Such application may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable application. Not later than 1 year after the date of enactment of this section, the Secretary shall issue draft guidance on the implementation of this section. Such guidance shall include examples of drugs that can be manufactured using platform technologies, including drugs that contain or consist of vectors and nucleic acids, information about the Secretary's review of platform technologies, information regarding submitting for designation, consideration for persons submitting a request for designation who has been granted a right of reference, the implementation of the designated platform technology designation program, efficiencies that may be achieved in the development and review of products that incorporate or utilize designated platform technologies, and recommendations and requirements for making and reporting manufacturing changes to a designated platform technology in accordance with section 506A. For purposes of this section: The term platform technology means— a technology incorporated into a drug or biological product, such as a nucleic acid sequence, molecular structure, mechanism of action, delivery method, or other technology the Secretary determines to be appropriate, or combination of any such technologies, that— is essential to the characterization of the drug or biological product; and can be adapted for, or incorporated or utilized in, more than one drug or biological product sharing common structural elements; or a standardized production or manufacturing process that is used to create or develop more than one drug sharing common structural elements that can be incorporated into multiple different drugs. The term designated platform technology means a platform technology that is designated as a platform technology under subsection (d). Nothing in this section shall be construed to— alter the authority of the Secretary to approve drugs pursuant to section 505 of this Act or license biological products pursuant to section 351 of the Public Health Service Act, including standards of evidence and applicable conditions for approval or licensure under the applicable Act; or confer any new rights with respect to the permissibility of a sponsor of an application for a drug product or biological product referencing information contained in another application submitted by the holder of an approved application under section 505(c) of this Act or of a license under section 351(a) of the Public Health Service Act. . Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, on the platform technology designation program under section 506K of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). Such report shall include— the number of requests for designation under such program; the number of designations under such program issued, active, and revoked; the resources required to carry out such program (including the review time used for full-time equivalent employees); any efficiencies gained in the development, manufacturing, and review processes associated with such designations; and recommendations, if any, to strengthen the program to better leverage platform technologies that can be used in more than one drug and meet patient needs in a manner as timely as possible, taking into consideration the resources available to the Secretary of Health and Human Services for carrying out such program.
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Sec. 506
Platform technologies
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