Sec. 701. Competitive generic therapies
705 words·~3 min read·
/bill/115/hr/2430/rh/section-701A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 506G the following: The Secretary shall, at the request of the sponsor of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of such drug pursuant to section 505(j). The sponsor of a drug may request the Secretary to designate the drug as a competitive generic therapy. A request under paragraph
(1)may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 505(j). A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition. Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary shall— determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy. In expediting the development and review of a drug under subsection (a), the Secretary shall, as requested by the sponsor, take actions including the following: Hold meetings with the sponsor and the review team throughout the development of the drug prior to submission of the application for such drug under section 505(j). Provide timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable. Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review, including with respect to drug-device combination products and other complex products. Assign a cross-disciplinary project lead for the Food and Drug Administration review team— to facilitate an efficient review of the development program and application, including manufacturing inspections; and to serve as a scientific liaison between the review team and the sponsor. In this section: The term generic drug means a drug that is approved pursuant to section 505(j). The term inadequate generic competition means, with respect to a product, there is not more than one approved drug product on the list of products described in section 505(j)(7)(A) (not including products on the discontinued section of such list) that is— the reference listed drug; or a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought. The term reference listed drug means the listed drug (as such term is used in section 505(j)) for the drug involved. . The Secretary of Health and Human Services shall— not later than 18 months after the date of enactment of this Act, issue draft guidance on the provisions of section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such provisions. The guidance issued under this subsection shall— specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); specify the actions the Secretary will take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and include good review management practices for competitive generic therapies. If the Secretary of Health and Human Services determines that it is necessary to amend the regulations under title 21, Code of Federal Regulations, in order to implement section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), the Secretary shall amend such regulations not later than 2 years after the date of enactment of this Act. In carrying out subparagraph (A), and in issuing any other regulations to implement such section 506H, the Secretary shall— issue a notice of proposed rulemaking that includes the proposed regulation; provide a period of not less than 60 days for comments on the proposed regulation; and publish the final regulation not less than 30 days before the effective date of the regulation.
Connectionstraces to 1
Traces to 1 document
U.S. Code
Citation graph
cites case law
Sec. 701
Competitive generic therapies
Cites 1Cited by 0 across 0 sources