The US Food and Drug Administration (FDA) is requesting public input on both the opportunities and challenges regarding drugs derived from botanical sources.
Botanical drug products are those developed from one or a combination of plants, algae, or macroscopic fungi. While there are approved drugs in this class, their complexity means research and development (R&D) is more difficult than traditional therapy modalities.
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Via a request for information (RFI), the FDA wants to find out more about the challenges encountered in botanical R&D from researchers, clinicians, and others in the pharma industry. Respondents are also encouraged to share innovative approaches they are using in the space, along with how they design studies are utilising real-world evidence (RWE).
The FDA’s aim is to provide a modernised regulatory framework to expand on the four currently approved botanical products. MediGene’s Veregen uses sinecatechins from green tea leaves for the treatment of genital and perianal warts; Napo Pharma’s antidiarrheal Mytesi is based on the red sap of the South American lechleri tree; Chiesi’s Filsuvez is a prescription topical gel made from birch bark extract for wound treatment. The fourth, approved via a biologics license application (BLA), is NexoBrid (anacaulase-bcdb), which is derived from a mixture of enzymes found in pineapples.
There is also a wealth of over-the-counter (OTC) botanicals that are popular for home management of certain conditions, which the FDA highlights as evidence of public interest in the products.
“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, deputy center director for substance use and behavioural health in the FDA’s Center for Drug Evaluation and Research (CDER).
Investing time to modernise regulatory pathways for botanical drug products is one of many strategies being carried out by the US administration in efforts to diversify modalities of approved therapies. For example, Trump’s administration has provided enhanced frameworks for psychedelics designed for mental health conditions.
“Under the Trump Administration, we are committed to modernising regulatory frameworks to ensure promising, natural health options are evaluated through rigorous science,” said acting FDA Commissioner Kyle Diamantas.
“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,” he added.
The public docket comes soon after a report by climate research group Zero Carbon Analytics demonstrated the therapeutic value of tropical rainforests. According to the group, protecting tropical forests – that harbour plants, fungi and microbes used in drug development – could offer between $382bn and $1.2tn in value for the pharmaceutical industry.
