By AMA Tells FDA To Keep Politics Out Of Botanical Drug Review
The American Medical Association (AMA) is urging federal officials to uphold “known and widely accepted scientific and clinical standards for testing safety and efficacy” of botanical drug products, including cannabis, kratom and other plant-derived substances, warning that political and commercial interests should not circumvent the standard approval process. The physicians’ group sent a letter to the Food and Drug Administration (FDA) last week, addressed to Grace R. Graham, the agency’s deputy commissioner for policy, legislation and international affairs.
The letter argued that “social and economic concerns and disputes should not be permitted to play a part” in the FDA’s decision-making process on regulations for botanical drugs. “The AMA believes that political considerations or conflicts of interest should not be allowed to overrule scientific evidence in making policy decisions,” the letter said.
The letter was sent in response to a request for information about botanical drug products that the FDA launched in September. AMA said it was “pleased” by recent moves by federal agencies to use emergency powers to schedule kratom-related compounds.
AMA Warns Of Public Health Harms From Botanicals
AMA said the growing use of botanicals raises public health concerns. “These principles are particularly important in light of the growing use and public health harms related to a wide range of botanicals, including kratom, cannabis, kava, kanna, and other botanicals that are increasingly used by consumers for specious health claims made by their manufacturers or influencers,” the letter said.
The organization warned that the FDA approval process for botanical drugs should not be short-circuited or circumvented merely because of anecdotal support or growing public use.
Physicians’ Group Supports Research On Cannabis’s Medical Potential
AMA also said a “special schedule” should be developed to support research on marijuana’s “potential medical utility.” The letter stated that federal agencies have a role in facilitating well-designed clinical research involving cannabis.
The group said high-quality clinical trials and postmarket safety monitoring are essential for botanical drug products.
