CDER’s Office of Compliance Kicks Off Annual Report Season with Rundown of 2023’s Major Public Health Enforcement Initiatives

The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OCs recent 2023 Annual Report—covering the fiscal year from October ’22 to September ’23—puts some meat on the bones of those issues and describes how OC touches almost every area of enforcement that CDER undertakes. One of 12 offices at CDER, a look at its annual report tells us a great deal about CDER’s enforcement priorities.

Led by former federal prosecutor Jill Furman, OC is charged with shielding consumers “from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions.” The tools it uses to accomplish that mission include those designed to help regulated entities that want to follow best public health practices, like guidances, public notifications, and requests for information. OC also has input into FDA’s more forceful enforcement measures, like warning letters, import alerts, and consent decrees.

Of course, CDER is a massive organization and OC doesn’t do its work alone. But its Annual Report is a helpful tool to highlight CDER’s post-pandemic public health enforcement priorities. Some takeaways on those efforts that we gleaned from the report:

Compounding. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding Quality Center of Excellence and its collaboration with the industry, but also the eleven warning letters FDA sent to drug compounders last year.

Drug Supply Chain. Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year. Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities.

Guidances. OC had a major hand in drafting some key guidances this year, including the recent draft guidance on Post-Warning Letter Meetings Under GDUFA, a potentially important enforcement guide for generic drug makers that we blogged on back in September.

Quality. According to the report, the most common FY23 CGMP citations from warning letters involved citations of quality units under 21 CFR 211.22, “Responsibilities of quality control unit.” In practice, this means that in addition to observations about specific quality deviations, FDA is intent to cite entire quality units for overall dereliction of duty. This is important information for every drug maker and its quality teams.

Clinical Trials. We’ve recently discussed FDA’s clinical trial oversight, and OC didn’t miss the chance to emphasize that it has a role in developing policy about how FDA-regulated research should be conducted. OC boasted of over 600 bioresearch monitoring inspections, 128 clinical inspection summaries, and 11 warning letters in the clinical trial space, among its other efforts.

FDA components aren’t always forthcoming with initiatives and statistics that provide insight into policy priorities. Additionally, annual reports can often be a collection of stylized, glossed-over stats masking bureaucratic shuffling. But at an agency where so many different offices are charged with working together across numerous missions, we were impressed with OC’s 2023 accomplishments. We also appreciate any glimpse we can get into the Agency’s compliance priorities.

Select Graphics and Charts from Office of Compliance 2023 Annual Report (here and here)