Commissioner of Food and Drugs – Food and Drug Administration
Good morning. I’m delighted to join you for this first annual Compounding Quality Center of Excellence Conference.
This is a virtual conference, but whether we are conducting this remotely or in person, the FDA’s commitment to our work and central mission – to protect and promote the public health — remains steadfast.
And the focus and theme of this meeting — “Working Together for Patient Safety” — go to the heart of that mission. As a science-based, public health agency, everything we do relates to this goal, including our efforts to protect the health of patients who receive compounded medicines.
Before we turn to the specific topic of today’s gathering, I want to take a moment to thank all of the participants for your continuing engagement and hard work, not just on the issue of compounded drugs, but for your continuing efforts to combat the COVID-19 virus by supplying medicines to care for those affected by the virus.
We recognize the enormous obstacles and challenges that many have faced during this pandemic, both in work and personal lives. It’s something we’ve shared at the FDA.
I’m especially proud of the role that the FDA has played on many different fronts in responding to the pandemic, from helping make sure that health care professionals have access to the personal protective equipment (PPE) they need, to facilitating the development of medical countermeasures to diagnose, treat, and prevent COVID-19.
FDA represents science in action and our more than 17,000 staff have performed exceptionally well on behalf of the American people.
We work closely with laboratories large and small, commercial manufacturers, and academia to support the development of medical devices, drugs, and biological products, including vaccines. We are engaging with many different drug manufacturers and providing guidance and technical assistance to expedite clinical trials for different products.
As you likely know, we’ve issued five temporary guidances related to human drug compounding and repackaging to help address drug supply interruptions and other risks related to COVID-19.
We’ve also worked with companies that don’t ordinarily make medical products but want to pitch in by making hand sanitizer or personal protective equipment.
To this end, we’ve issued guidances to help boost supply and production of alcohol-based hand sanitizer, and have supported efforts by compounding pharmacies in this area, under certain circumstances.
We’ve done a great deal to address new risks that are part of these developments, such as recently identified methanol contamination in hand sanitizers, which the FDA is continuing to investigate.
But even as we are immersed in the response to COVID-19, the FDA has continued to maintain our regular mission critical work.
We continue successfully to fulfill our many other responsibilities — approving new drugs and biological products, approving and clearing medical devices, responding to the opioid crisis, maintaining our high standards of food safety, and continuing oversight of tobacco products, including e-cigarettes, to name just a few.
The strength of the FDA comes from our commitment to science, but also from the diligence and skill of our capable and committed staff.
Which brings me back to the subject of today’s meeting and the work of the diverse group of stakeholders who are gathered here today – including outsourcing facilities, other compounders, state regulators, some of our federal partners, and of course many FDA officials.
I know that you will have a stimulating and productive discussion on the important topics of compounding quality and policy, with a future that ensures patient safety.
At the FDA, we recognize the vital role of compounded drugs in patient care when FDA-approved drugs are not available. This is an important public health issue and we are looking forward to the dialogue.
Indeed, during my years as a practitioner I saw first-hand the critical role compounded drugs can play in caring for some patients.
But even as we understand how important these drugs can be to patients who need them, we also are aware that compounded drugs are not reviewed by the FDA for safety, effectiveness, or quality before they are marketed for patient use, and as such, can pose ongoing and serious risks.
That’s why it’s important that we provide appropriate oversight of these products, and guidance to the industry, to help reduce those risks.
To do that, we’ve taken a balanced approach that preserves access to compounded drugs for patients who have a medical need for them, while also protecting patients from the risks associated with those compounded drugs that are not made in accordance with applicable quality standards or other requirements.
As you are well aware, , Congress passed the 2013 Drug Quality and Security Act, in part, to help provide a source of higher-quality compounded drugs for hospitals and other providers.
This Act created the category of outsourcing facilities, which are able to produce drugs on a larger scale than traditional compounders.
Additionally, and importantly, unlike most other compounders, these manufacturers are subject to current Good Manufacturing Practices and must register with the FDA and be subject to regular, risk-based inspections by the FDA.
As this sector has matured and grown (with about 75 registrants currently), we understand the challenges that some companies face in meeting quality standards and work regulatory complexities.
Our goal has always been to work closely with these facilities. Since the law’s enactment, the FDA has been advancing a number of efforts to collaborate with, and to support outsourcing facilities.
Last year, in collaboration with CDER’s Office of Compliance and Office of Pharmaceutical Quality as well as the FDA’s Office of Regulatory Affairs and other FDA offices, we launched the Compounding Quality Center of Excellence.
The Center of Excellence will offer the FDA new ways to engage with outsourcing facilities, including trainings on current good manufacturing practice related topics, and opportunities to find new ways to improve the overall quality of compounded drugs.
We will continue to develop policies, conduct stakeholder outreach, and oversee compliance efforts that support outsourcing facilities in producing compounded drugs that meet applicable quality standards.
It is particularly important that outsourcing facilities be able to meet provider needs for office stock of non-patient-specific compounded drugs, as they are the only type of compounding entity that may distribute compounded drugs to providers, under federal law, without first obtaining a patient-specific prescription.
As we continue to move forward in this area to implement these provisions, we want to work with you to ensure that our approach is a balanced one, consistent with the framework set out by the Drug Quality and Security Act, in which traditional compounders and outsourcing facilities each play a role in meeting patients’ needs for compounded drugs.
We have come a long way over the past seven years, but we have much more to do.
We look forward to continuing to engage with outsourcing facilities and other compounders to promote patient safety and high-quality drug production.
Thank you for your participation and we look forward to working with you.