Findings

Congress finds the following: (1)Chronic and age-related diseases are among the leading causes of disability, impaired quality of life, and health care spending in the United States. (2)Many chronic and age-related diseases involve multiple biological pathways and complex pathophysiology, yet most currently approved therapies are designed to target a single molecular pathway. (3)Botanical drugs regulated by the Food and Drug Administration (in this section referred to as the FDA) under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) may contain multiple naturally occurring active constituents capable of acting on multiple biological pathways simultaneously and safely. (4)Since the FDA established a regulatory pathway for botanical drugs in 2004, only a limited number of botanical drugs have received approval, despite significant scientific and therapeutic potential and the growing interest of patients in evidence-based, FDA-approved treatment options derived from natural products. (5)In addition to the costs associated with the clinical development of conventional synthetic drugs, botanical drugs present unique scientific and manufacturing challenges arising from the natural variability of plant-derived raw materials, including the need for extensive sourcing controls, batch consistency testing, constituent characterization, and standardization processes to ensure safety, quality, and effectiveness. These additional development burdens may increase costs and commercial uncertainty for sponsors seeking to bring innovative botanical therapies to market. (6)As a result of these unique scientific, manufacturing, and regulatory challenges, existing intellectual property and regulatory exclusivity frameworks may not provide sufficient incentives to support private investment in the research and development of innovative botanical drugs. (7)Congress has previously recognized that certain categories of complex medical products require tailored periods of regulatory exclusivity to encourage innovation and facilitate long-term investment in research and development. (8)Expanding incentives for the development of safe and effective botanical drugs may increase multi-target treatment options for patients suffering from multi-pathway, chronic and age-related diseases while promoting biomedical innovation and economic growth in the United States. (9)Advances in computational biology, artificial intelligence, and systems pharmacology have created new opportunities to identify and develop innovative botanical drug combinations capable of addressing complex diseases through multi-pathway mechanisms of action. (10)It is in the public interest to encourage the development and approval of multi-target, evidence-based, FDA-regulated botanical drugs subject to the same standards of safety and effectiveness applicable to other drugs regulated by the FDA.

Period of market exclusivity for botanical drugs

Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E)) is amended by adding at the end the following:

(vi) (I)A botanical drug approved under subsection (b)(1) pursuant to an application submitted after the date of enactment of this clause shall be entitled to a 12-year period during which no application submitted under subsection (b)(2) or (j) that references or relies upon such drug may become effective. (II)In this clause, the term botanical drug means a botanical drug subject to subsection (a), as determined by the Secretary by regulation.