FDA, Congress Move to Advance Botanical Drug Development

The U.S. Food and Drug Administration issued a request for information (RFI)  to gather public input on opportunities to advance the development of botanical drug products. Meanwhile, Congresswoman Lauren Boebert (R-CO) introduced a bill that would provide botanical drugs with a 12-year regulatory exclusivity period for botanical drugs, similar to the guaranteed market monopoly granted to biologics under federal law.

A Unique R&D Pathway for Plant-Based Drugs

Botanical drug products are products that include or may be derived from plant materials, algae, macroscopic fungi, or combinations of these materials and are intended to diagnose, cure, mitigate, treat or prevent disease. While there is broad interest in botanical products, their inherent complexity and variability can present unique challenges for research, product development and regulatory review, FDA reported.

“Under the Trump Administration, we are committed to modernizing regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science,” said Acting FDA Commissioner Kyle Diamantas JD “Botanical drug products represent a critical area where greater scientific development can unlock new therapeutic opportunities for American patients while maintaining the highest safety standards.”

“Given that many people use botanicals for self-treatment, botanical drug products represent an area where greater scientific development could create new opportunities for patients,” said Marta Sokolowska, PhD, deputy center director for substance use and behavioral health in the FDA Center for Drug Evaluation and Research. “We want to hear directly from researchers, clinicians, industry and other stakeholders about the barriers they face and practical approaches that could help bring safe and effective botanical drugs to patients.”

To date, four botanical products have been approved for marketing as prescription drugs through FDA’s new drug application and biologics license pathway, which was established in 2004 and updated with guidance issued in 2016. Under this new pathway, manufacturers can allow plant-based, complex mixtures to undergo New Drug Application (NDA) approval without requiring manufacturers to isolate a single active pharmaceutical ingredient (API). However, few drugs have secured FDA approval due to the cost of Phase II and III trials, coupled with weak patent protections for naturally occurring compounds.

FDA is seeking to build on the agency’s experience with these products and other botanical drug development programs to help accelerate development through additional scientific and stakeholder engagement.

FDA recently collaborated with the Reagan-Udall Foundation for the FDA on a roundtable to gather information on botanical drug development, and will also convene a joint workshop with the European Medicines Agency on Sept. 25 to discuss regulatory considerations.

Through the RFI, FDA is looking for feedback on topics such as R&D challenges, approaches to support development, potential updates to FDA guidance and other resources, quality standards, study designs, and the potential use of real-world evidence and other scientifically credible information.

The Advancing Botanical Drug Development Act

The bill introduced by Boebert on August 27 would provide drug developers with a guaranteed period of regulatory exclusivity on qualifying botanical drugs under federal law, similar to protections that the government gives biologics (complex medicines made from living organisms), which receive a 12-year market monopoly.

Patent law makes it difficult to achieve IP protections for naturally-occurring compounds, reducing the incentive for pharmaceutical companies to invest in botanical drug development.

“Botanical drugs are FDA-approved medicines, not dietary supplements,” Boebert said. “Because they contain many natural compounds, they can work on multiple targets at once, which may help with complex chronic and age-related conditions such as Alzheimer’s, Parkinson’s, type 2 diabetes, rheumatoid arthritis, autism, and PTSD.”

The bill also aims to reduce exemptions placed on botanical compounds for pharmaceutical trials, creating certainty to support the development of natural, multi-constituent drugs.

“This practical step will encourage more rigorous development of innovative medicines and keep America at the forefront of biomedical progress,” said Boebert.