The American Herbal Products Association (AHPA) submitted comments to the U.S. Food and Drug Administration (FDA) in response to a request for information on the challenges and opportunities facing botanical drug development.

In 2004, FDA published botanical drug guidance intended to facilitate the approval of over-the-counter (OTC) and prescription drug products derived from or consisting of botanicals.

The guidance was last updated in 2016 and provides drug developers with significant flexibilities—reflecting the complexities of botanical ingredients—including an opportunity to satisfy Phase 1 and 2 safety evidence requirements via a documented history of use. However, few botanical drugs have received new drug approvals, according to AHPA.

In its comments, AHPA emphasized utility of the current botanical drug framework and the distinct benefits of botanical drugs in the marketplace, while acknowledging FDA could do more internally to support the pathway.

AHPA urged FDA to take further action to promote the pathway to candidate sponsors and potential investors by enhancing internal expertise through hiring reviewers with botanical expertise such as qualified pharmacognosists. The comments also emphasize botanical drugs ultimately serve a separate, complementary health role alongside herbal dietary supplements.

“The current botanical drug guidance provides a strong framework,” said AHPA President and CEO Graham Rigby. “But fulfilling the intended purpose of the guidance would require FDA to publicly communicate the availability and advantages of its approach to candidate botanical drug products. Further, realizing that purpose would require the agency to enhance institutional botanical expertise that can foster plant-based medicine candidates’ progressing through the pipeline.”

For more information, visit www.ahpa.org.