FDA’s Office of Compliance (OC) recently published its Annual Report for Fiscal Year 2022.1 The report was introduced by Director Jill Furman. Ms. Furman took over the director’s role in late 2022, following the retirement of former director Don Ashley. Ms. Furman highlighted in her opening message in the report that OC took critical steps to reduce the impact of the overdose crisis, protect patients from poorly compounded drugs, alert the public about misleading and potentially dangerous products, implement the Drug Supply Chain Security Act, and enhance risk-based monitoring of clinical trials.
From the perspective of promoting compliance, the Office of Compliance reported proposing two new rules, 10 new guidance documents, 80 conference presentations, 32 public notices of fraudulent health products, 13 presentations shared on FDA’s YouTube channel, and 2,700 courses in compounding excellence completed by stakeholders. Reporting on regulatory and enforcement actions, OC issued 101 warning letters, classified 343 drug recall events, completed two consent decrees, added 50 facilities to FDA’s import alerts, and completed 99% of all clinical inspection summaries on time.
Of the 10 Public Health Risks Alerts issued by the OC, one was “Risks of giving homeopathic cold and cough medicine to very young children. FDA issued this notice in October of 2021, (Read more in a member-exclusive memo from AAHP Counsel Al Lorman). Historically FDA made this announcement at the beginning of cough/cold season in connection with traditional OTC drugs. In this announcement, FDA included homeopathic cough/cold medicines for the first time. The way the Office of Compliance called that out in their annual report leads one to believe that this was a contemplated action on their part that took some effort.
The publication also reported on product testing efforts at the Office of Compliance. It stated that CDER may initiate testing of certain types of products to help ensure high-quality drugs are sold in the U.S. In FY 2022, FDA testing identified homeopathic aqueous-based drug products containing objectionable microbial contamination, including Bacillus cereus. The testing identified three products that were subsequently recalled, as use of contaminated product by certain populations could potentially result in severe or life-threatening adverse events.
The reporting of actions against homeopathic products in this high-profile manner demonstrates that CDER and the Office of Compliance specifically are carefully considering public health risks associated with homeopathic drug products at high risk for contamination or labeled for vulnerable populations.
Readers are advised to review FDA Public Health Alerts and warning letters carefully for implications for your own products.
1 United States Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Compliance Annual Report FY 2022 published March 17, 2023. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-compliance