- Speech by
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
Good morning and welcome. I am delighted to have the opportunity to speak with you today at this very important intergovernmental meeting – our ninth such meeting on the topic of drug compounding. I only wish I could be with you in person.
I know that each of you is committed to safeguarding the health and welfare of the people in your jurisdiction, and at FDA we share your commitment to protecting and promoting the public health.
This includes working with you and your agencies to address the potential risks associated with compounded drugs, while preserving appropriate access for the patients who have a medical need for them.
Our shared commitment to collaboration is more important than ever in light of the enormous challenges presented by the COVID-19 pandemic.
During this pandemic, acute shortages of drugs needed for critically ill patients have presented serious challenges for our health systems, our supply chains, and for us as regulators.
As you likely know, we’ve issued five temporary guidances related to human drug compounding and repackaging to help address potential drug supply interruptions and other challenges related to COVID-19.
As everyone here recognizes, compounded drugs serve an important role for patients whose medical needs cannot be met by an FDA-approved drug. Because compounded drugs are not approved by the FDA, they have not been evaluated for safety, effectiveness, or quality.
We’ve seen firsthand the harm that can be caused to patients from poor quality compounded drug products, which is one reason why we need to continue to encourage that compounded drugs only be used when an FDA approved drug is not appropriate to meet a patient’s medical needs.
This is why we must continue to work together to protect patients from the risks associated with poor quality, contaminated or otherwise harmful compounded drugs.
The careful balance of risk mitigation and patient access is especially critical during these unprecedented times.
FDA and state regulators are working hard to ensure hospitals and patients can get the drugs they need, including providing additional, temporary flexibility to ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19.
At this year’s meeting, we will continue to focus on collaboration, particularly information-sharing, between FDA and state officials. We want and need to continue to learn from each other so we can effectively address the challenges we face and serve the public.
One of the most anticipated new mechanisms for information-sharing and collaboration is the FDA-State Memorandum of Understanding – or “MOU” – addressing interstate distribution of compounded drugs.
The MOU has been publicly available on FDA’s website marking a significant milestone in the agency’s regulation of human drug compounding and reflecting years of collaborative dialogue and stakeholder input.
We appreciate the thoughtful comments that were provided on the MOU, and we hope that the final text will offer states helpful flexibilities without compromising our shared public health mission.
One particular area of concern raised by stakeholders was that additional resources may be needed by some states to collect information to satisfy obligations under the MOU, when finalized and signed.
To that end, we are also excited about our partnership with the National Association of Boards of Pharmacy to create an information sharing network to help facilitate information sharing between federal and state regulators, including information concerning the interstate distribution of compounded drugs. The system will be available to all states, but we hope it will be a particularly meaningful tool for states that sign the MOU.
You will hear much more about the MOU, the information-sharing network and other important updates from my colleagues at the FDA, NABP and state regulatory leadership.
We anticipate that the final MOU, once signed, will help facilitate increased collaboration between the FDA and the states that sign it. Working together, we can help promote quality compounding practices and better respond to emerging public health concerns that may affect patients.
We’ve worked hard to refine our existing practices, shape new policies, and increase the frequency of our communications with states, as well as other stakeholders. We have an obligation to continue to improve the quality of compounded products for consumers by ensuring we have a strong and modern regulatory framework in place.
After your discussions today and tomorrow, we look forward to your feedback. We know that we are confronting many of the same challenges as you, and we are eager to hear about your ongoing work related to compounding regulation and how you are confronting these challenges in your jurisdictions. We take seriously our obligation to continue our efforts to improve the quality of compounded products for consumers, as we know you do too.
We refer to this gathering as an intergovernmental working meeting because it is built on federal and state interaction with a shared commitment to advance public health.
Meaningful oversight of drug compounding is profoundly important, and we are grateful for your partnership as we work to ensure that patients have access to the therapies they need, and that those therapies are of appropriate quality. My intergovernmental affairs team is here to assist you. Please 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 and your state agencies is critical to maintaining strong and steady oversight of compounders to protect the health of the American public.
Thank you again for taking the time to attend this year’s meeting, and we look forward to a productive dialogue.