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Official statements, legislative developments, regulatory news, and resources from AIM and the broader botanical medicine policy landscape.

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U.S. Capitol building — seat of Congress

119th Congress

Legislative UpdateCongressional RecordAugust 27, 2026

Advancing Botanical Drug Development Act of 2026 Introduced in Congress

Rep. Lauren Boebert of Colorado, joined by Rep. Derrick Van Orden of Wisconsin, introduced H.R. 10150 in the U.S. House of Representatives. The legislation was referred to the House Committee on Energy and Commerce and proposes a period of market exclusivity for qualifying botanical drugs, addressing longstanding barriers in FDA-regulated botanical drug development.

Source: U.S. Congress / Rep. Boebert's Office

Rep. Boebert's Announcement Official Bill Record — H.R. 10150

H.R. 10150 Resources

Official congressional and federal agency resources on the Advancing Botanical Drug Development Act of 2026.

Official Bill Text Rep. Boebert's Announcement FDA Botanical Drug Resources

Latest Coverage

News & Regulatory Updates

FDA & RegulatoryFDA OfficialSeptember 3, 2026

FDA Seeks Public Input to Advance Development of Botanical Drug Products

The FDA issued a Request for Information seeking public input on opportunities and barriers affecting botanical drug development, including research, clinical development, quality standards, study design, and regulatory pathways. Four botanical products have been approved for prescription marketing to date.

Source: U.S. Food & Drug Administration

FDA & RegulatoryFDA OfficialOngoing

FDA Botanical Drug Products: Agency Initiatives and Resources

The FDA's botanical drug products hub outlines the agency's ongoing work to advance botanical drug development, including its Request for Information, regulatory guidance, collaboration with the Reagan-Udall Foundation, and joint FDA/EMA activities.

Source: U.S. Food & Drug Administration

FDA & RegulatoryFDA / EMA JointSeptember 25, 2026

FDA and EMA Convene Joint Workshop on Botanical Drug Development

The FDA and the European Medicines Agency convened a joint workshop examining regulatory considerations surrounding herbal medicinal and botanical drug product development, addressing challenges developers face under U.S. and European regulatory frameworks.

Source: U.S. Food & Drug Administration / European Medicines Agency

Research & InnovationFDA EducationalReference

What Is a Botanical Drug? — U.S. Food & Drug Administration

The FDA's educational resource explains what qualifies as a botanical drug, how these products are regulated, FDA development guidance, regulatory considerations unique to complex botanical products, and currently approved botanical products.

Source: U.S. Food & Drug Administration

Media Coverage

Independent reporting from outlets including Politico, Bloomberg, Axios, The Hill, STAT News, Endpoints, Fierce Biotech, and BioWorld will be featured here as coverage of H.R. 10150 and the botanical drug development initiative develops.

Press

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Members of the press seeking information about AIM, H.R. 10150, or the coalition's advocacy work are encouraged to reach out directly.

AIM is a nonpartisan national advocacy coalition. All media inquiries are handled by coalition staff.

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