- Speech by
Robert M. Califf, M.D., MACC
(Remarks as prepared for delivery)
Good morning and thank you, Nick [Alexander]. I'm honored to have the opportunity to address this gathering of state regulators.
This is the eleventh annual intergovernmental working group meeting on drug compounding.
These annual meetings are a touchstone to measure how far we have come, together, in governing towards excellence in the field of compounding, as we reflect on our accomplishments and the work still to be done.
The conference reminds me that I ran a satellite compounding pharmacy on our Cardiac Intensive Care Unit in the early days of using IV nitroglycerine in the treatment of cardiovascular disease. I understand the importance of clinical flexibility, but I also understand the importance of quality systems in this area.
This year also marks a somber milestone, which is ten years since an outbreak of fungal meningitis sickened more than 700 people and was associated with 64 deaths.
I know that we are all driven by the memory of those patients and their families to make compounded drugs as safe as possible, and to do everything we can to prevent harm on this scale.
To that end, over the past ten years, the FDA and state regulators have worked hard to strengthen our oversight of drug compounding. We have sought not only to support access to compounded drugs, which can serve an important role for patients whose medical needs cannot be met by FDA-approved drugs, but also to protect patients from unsafe and poor-quality compounded drugs that may cause them harm.
The FDA has made great strides to implement federal law on drug compounding following the passage of the Compounding Quality Act in 2013, in which Congress clarified the statutory framework for the regulation of compounded drugs and established the outsourcing facility sector.
We established an Office of Compounding Quality and Compliance (OCQC) to centralize our work on drug compounding. This office employs many subject matter experts and specialists, many of whom are pharmacists.
The FDA has published more than 50 policy documents on drug compounding to enhance patient safety and drug quality. This important work continues, with eight draft, revised draft, and final guidance documents as well as five regulations currently in active development.
Additionally, OCQC continues to issue warning letters, recommend voluntary recalls, and pursue injunctions, among other actions, in order to prevent contaminated and unsafe compounded drugs from reaching patients.
The Compounding Quality Center of Excellence, launched in 2019, has provided free trainings to those working in the compounding field. The Center of Excellence will shortly be launching new courses, both instructor-led and self-guided.
This year’s Compounding Quality Center of Excellence Conference set new attendance records with more than 800 attendees who spent two and a half days immersed in discussions about the shared pursuit of compounding excellence.
We also have a new and growing team dedicated to outreach with the compounding sector. We are proactively engaging with compounders through annual conferences, listening sessions, and meetings with regulatory associations.
But even as we have made enormous progress together, there are still many areas that need work.
We want to take this opportunity to communicate with you about our work in these areas.
To that end, we trust that our upcoming notice and comment rulemaking to address provisions in federal law regarding certain distributions of compounded drugs and a standard Memorandum of Understanding between FDA and states will enhance mutually beneficial communication. We look forward to updating you on this effort in the coming months.
We are also aware of the existence of activities that present oversight challenges, such as IV hydration facility business models that involve multiple professional disciplines and licensing boards.
As compounding business practices evolve, we as regulators must do the same. Increasingly, we see a need to work with our colleagues in boards of medicine, nursing, and other health professions to better understand practices and challenges in their space and to ensure that new and unsafe practices don’t emerge without proper oversight.
I hope the conversations over the next two days will identify opportunities for more communication and collaboration on these issues.
We must continue to balance the clarion call to protect patients from unsafe, ineffective, and poor-quality compounded drugs with the equally important goal of supporting access to high-quality compounded drugs for patients who have a medical need for them.
This is a tough job and a high bar, and I am grateful to all of you for the work you do both independently and collaboratively with us to help actualize it.
We greatly value our relationship with our state regulators, fellow federal agency, and health professional partners who were able to join us for this meeting. We look forward to a productive dialogue during each of the sessions.
In the meantime, please know that this intergovernmental working group meeting is designed as a space for creative discussion, collaboration, and, of course, constructive criticism about how we undertake our shared commitment to advancing public health.
In support of our ongoing collaboration, my intergovernmental affairs team is here to assist you. I hope you will use them as a resource in your interactions with the agency.
We appreciate the work you do; we respect the important role that you play in protecting the public health, and we know that our collaboration with you is critical to maintaining strong and steady oversight of compounders to protect the health of the American public.
Before closing, let me put in a pitch for vaccination. We’re worried about the new variants and the data are clear that people who are fully updated on their vaccination have a very low risk of death or hospitalization from Covid. Almost all the ICU patients and deaths from Covid were not up to date on their vaccinations. While you’re at it, get that flu shot also.
Thank you again for joining us for this intergovernmental working group meeting. We look forward to a productive dialogue.