FDA review process essential to ensure "botanical" safety
The AMA is urging the Food and Drug Administration (FDA) to uphold rigorous, evidence-based standards for evaluating botanical drug products, warning that those marketed with unproven health claims can pose serious risks when their safety and efficacy have not been established.
In a letter (PDF) to FDA Deputy Commissioner Grace R. Graham, the AMA emphasized that botanical products—including kratom, cannabis and other plant-derived substances—should be subject to the same scrutiny as other drugs. Growing consumer use, anecdotal claims and marketing by social media influencers should not circumvent the FDA approval process or replace the requirement for high-quality clinical trials and postmarket safety monitoring.
“As botanical manufacturers develop increasingly potent products in everything from gummies and powders to oils and injections, consumers are becoming the real-world guinea pigs—and suffering tragic consequences, including dependence, substance use disorders, overdose, and death,” said AMA President Willie Underwood III, MD, MSc, MPH. “Calling something ‘natural’ doesn’t make it safe. We need science, not social media hype, to determine what belongs in our medicine cabinets.”
HHS non-enforcement peptide policy puts patients at risk
A new federal policy that effectively authorizes the compounding of non-FDA-approved substances puts patients at increased risk for serious, preventable harm, said AMA President Willie Underwood III, MD, MSc, MPH. The proposed policy from the U.S. Department of Health and Human Services (HHS) says that “HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A.” Those substances include BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.
“Allowing pharmacies to compound unapproved synthetic peptide substances without sufficient evidence of their safety and efficacy puts patients at risk," said Dr. Underwood.
The AMA outlined detailed concerns in a recent letter to FDA (PDF), including the peptides’ “lack of nomenclature consistency and clarity, [and] foundational elements of drug development remain incomplete for these synthetic peptides. These missing elements include characterized formulations, validated pharmacokinetics, toxicology and safety profiles, established dosing parameters including routes of administration, and quality specifications and manufacturing controls necessary to ensure the identity, purity, and consistency of the substance.”
The AMA is concerned that without this information, “physicians cannot reasonably determine whether prescribing such products is consistent with accepted standards of medical practice, consistent with the federal mandate that prescriptions be issued for a legitimate medical purpose in the usual course of professional practice. Likewise, pharmacists lack the information necessary to establish appropriate quality assurance and quality control procedures.”
AMA, Ochsner Health highlight electronic prior authorization readiness
The AMA and Ochsner Health recently hosted an Advocacy Insight Network webinar to help health systems prepare for electronic prior authorization. Ochsner leaders shared their experience as an early adopter and discussed the importance of collaboration among health systems, electronic health record (EHR) developers and payers as the Jan. 1, 2027, implementation date approaches.
Ochsner is taking a phased approach. Physicians and staff can now enter a procedure into the EHR and receive real-time feedback on whether prior authorization is required. The health system is also working to automatically populate information needed for a request and ultimately receive decisions electronically, helping reduce administrative work and delays in patient care.
Ochsner is among the organizations that signed a voluntary pledge through the Centers for Medicare & Medicaid Services’ (CMS) Health Tech Ecosystem to accelerate electronic prior authorization. The initiative brings health systems, medical practices, EHR developers, payers and other partners together to test the technology and address workflow, technical and operational barriers.
The AMA has strongly advocated for electronic prior authorization that reduces physician burden and improves timely access to care. In a letter to CMS (PDF), the AMA urged the agency to retain the Jan. 1, 2027, compliance date for federally regulated payers. The AMA continues to work with the administration to ensure electronic prior authorization is successfully implemented and is pressing payers and EHR developers to provide physicians with the education, training and support needed to adopt the technology.
The transition to a fully electronic process will take time. The AMA encourages physicians and practices to contact their EHR vendors and health plans now to ask when electronic prior authorization will be available, when testing will begin and what training will be offered.
