Staying Compliant in 2023

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Promoting compliance, regulatory and enforcement actions, and organizational excellence, while practicing voluntary compliance are some of the ways that top leaders in the space can be vigilant when looking at recent actions and inspections, according to a session at the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC (1).

In the session “Compliance Office Updates,” Melissa J. Mendoza, JD, acting director, Office of Compliance and Biologics Quality, Center of Biologics Evaluation and Research (CBER), FDA, and Jill Furman, JD, director, OC, Center for Evaluation and Research (CDER), FDA, both shared their updates from CBER and CDER and the initiatives that their organizations have taken to combat regulatory challenges and enforcement strategies.

According to Mendoza, CBER has been adjusting to significant leadership and organizational changes for the past two years, including a new office, called “The Office of Therapeutic Products,” that was developed following the reorganization of the Office of Tissues and Advanced Therapies. Further, she reiterated the end of the COVID-19 Public Health Emergency on May 11, 2023, which is different from the Emergency Use Authorization of COVID-19 vaccines that have updated on Sept. 11, 2023. The vaccine updates include a monovalent component that corresponds to the omicron variant.

Mendoza discussed how many good manufacturing practice (GMP) warning letters have been addressed this past year, specifically with firms that are manufacturing biologic products that are unapproved and unlicensed and/or violate GMP, such as umbilical cord blood issues or amniotic fluid eye drops, which are a very concerning and significant safety concern for FDA now. Raw material control and testing and lab controls are also included in the top GMP complaints, according to Mendoza. “Compliance work will reveal certain trends and products that are available that require a public safety alert,” she said. Although there are very public actions taken, such as recalls, letters, and statements, that CBER participates in when there are compliance issues, Mendoza emphasized that there are a lot more things that go on behind the scenes that are intended to prevent the need to take even more compliance action in the first place.

As for CDER, Furman defined the organization’s mission to shield the public from poor quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement action. “There are many persistent and emerging risks in each of the areas that we regulate, and confronting each individual risk requires thoughtful planning and the right regulatory approach depending on the circumstance,” she said.

Furman continued by describing how recent activities have happened to promote voluntary compliance, which means being transparent with the public and using feedback/data towards decisions. For example, there are numerous pieces of guidance related to compounding, clinical trial oversight, and the Drug Supply Chain Security Act, and stakeholder feedback is a critical component to all these areas. She also mentioned how resources like FDA’s data dashboard, holding public meetings with stakeholder feedback, and trainings to develop more for compliance are all beneficial. “We want to remain nimble in order to respond to emergencies rapidly and effectively,” she said.

Reference

1. Furman, J; Mendoza, M. Compliance Office Updates. Presentation at the 2023 PDA/FDA Joint Regulatory Conference, Washington, DC, Sept. 18–20, 2023.