Promising Pathway Act 2.0

[Congressional Bills 118th Congress] [From the U.S. Government Publishing Office] [H.R. 9938 Introduced in House (IH)] <DOC> 118th CONGRESS 2d Session H. R. 9938 To amend the Federal Food, Drug, and Cosmetic Act to establish a time- limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES October 4, 2024 Mr. Westerman (for himself and Mr. Mike Garcia of California) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To amend the Federal Food, Drug, and Cosmetic Act to establish a time- limited conditional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Promising Pathway Act 2.0''. SEC. 2. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS FOR INDIVIDUALS WITH RARE, PROGRESSIVE, AND SERIOUS DISEASES. (a) In General.--Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end of the following: ``SEC. 524C. CONDITIONAL APPROVAL OF HUMAN DRUGS FOR INDIVIDUALS WITH RARE, PROGRESSIVE, AND SERIOUS DISEASES. ``(a) Conditional Approval; Priority Review; Other Designations.-- ``(1) In general.--The sponsor of a drug may file with the Secretary an application for conditional approval of an eligible drug described in subsection (b). The Secretary shall approve or deny such application in accordance with subsection (c). ``(2) Priority review.--The Secretary shall give priority review to an application for conditional approval of an eligible drug described in subsection (b). ``(3) Other designati