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FDA Insight: Episode 23 – Transcript

>> Anand Shah: Happy New Year, and welcome back to another episode of FDA Insight.

I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at FDA. Thank you so much for joining us for another great episode.

This week, we'll be discussing FDA's efforts involving compounding, patient safety, and compounding's contribution to fighting COVID-19.

My guest today is Ms. Gail Bormel, the FDA's Acting Associate Director for Compounding. Ms. Bormel leads the efforts in CDER's Office of Compliance to address Compounding policy, inspections, incidents, and the Compounding Quality Center of Excellence. Ms. Bormel, welcome to FDA Insight.

>> Gail Bormel: Thank you for having me on the show today, and happy New Year to you.

>> Anand Shah: Well, thank you. Well, let's jump right in. What is compounding?

>> Gail Bormel: Well, compounding is generally when a licensed pharmacist or a licensed physician, or in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients of a drug to create a medication that's tailored to the needs of an individual patient. For example, you could customize the dose or strength of a medication or remove certain ingredients in it that may cause an allergic reaction in some people. Just to follow up on that, FDA's compounding program aims to protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving their access to lawfully marketed compounded drugs. These would be drugs for patients who have a medical need for them.

>> Anand Shah: Why do some patients need compounded drugs?

>> Gail Bormel: Compounded drugs serve an important medical need for patients who cannot be treated with an FDA approved medication, such as a patient who has an allergy and needs a drug to be made without a certain dye, or an elderly patient or a child who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage form.

>> Anand Shah: Are compounded drugs approved by the FDA?

>> Gail Bormel: No, compounded drugs are not FDA approved. And what this means is FDA does not verify the safety effectiveness or quality of compounded drugs before they're marketed.

>> Anand Shah: So how does FDA oversee compounded drugs, if at all?

>> Gail Bormel: Well, let me just first say that patient safety is one of FDA's highest priorities, as you know. FDA plays a critical role in protecting patients from poor quality compounded drugs and helping to ensure that quality compounded drugs reach patients in the United States. We consider this to be a shared responsibility with compounders and state regulators. So, compounding occurs in thousands of pharmacies across the country, and the agency works with state to oversee compounding pharmacies to help assure that they fulfill their responsibilities for patient safety. In addition, FDA also provides primary oversight role for a special group of compounders called outsourcing facilities that register with the agency. They need stricter quality standards and can compound on a larger scale. And so, what FDA does is to take action, appropriate action, when compounding pharmacies and outsourcing facilities do not follow the law and they put patients at risk.

>> Anand Shah: What are the risks associated with compounded drugs?

>> Gail Bormel: Well, we've seen firsthand the harm compounded drugs can do and what they can cause patients when they are not appropriately compounded. Patients need to understand the risks of compounded drugs. If there are poor compounding practices, these can result in serious drug quality problems such as contamination or a drug that contains too much of an active ingredient. This can lead to serious patient injury and death. Some compounders engage in activities that put patients at risk and/or undermine the FDA drug approval process. For example, in addition to the poor compounding practices that I mentioned, FDA has observed that some compounders have made false and misleading statements that compounded drugs are safe and effective, sometimes for the treatment of serious diseases. So, what does the agency do to address this? Well, we conduct risk-based inspection and enforce some efforts with respect to compounders, and we take action against facilities with deficient practices to try and stop issues before they lead to patient harm.

>> Anand Shah: What can patients do to protect themselves?

>> Gail Bormel: Well, patients should always talk to their doctors about what medicines they are taking. If a patient has a serious reaction to a compounded medication, they should seek emergency medical care. Patients and healthcare professionals should also report adverse events to FDA's MedWatch and Adverse Event Reporting Program. Patients can also monitor the resources on FDA's website about compounding. We have a pretty extensive website on this issue.

>> Anand Shah: Ms. Bormel, who can compound drugs?

>> Gail Bormel: Well, there are two categories of compounders. Federal law addresses compounding in state licensed pharmacies and by doctors, as well as compounding in an outsourcing facility. Outsourcing facilities are a relatively newer category of compounders that were established in 2013 by the Drug Quality and Security Act. Outsourcing facilities are inspected by FDA according to a risk-based schedule and they're subject to more stringent quality standards.

>> Anand Shah: So, who's inspecting these compounders?

>> Gail Bormel: The FDA and state boards of pharmacy inspect compounders. Generally, the state boards of pharmacy have primary responsibility for the day-to-day oversight of state licensed pharmacies that are not registered with the agency as the outsourcing facility. However, we also conduct inspections of compounding pharmacies. Facilities that choose to register with the agency as outsourcing facilities are primarily overseen by FDA, and we use risk-based inspection approach, the prioritizing inspections, and we address the greatest risks to patients by doing so.

>> Anand Shah: Can you tell us a little bit about the quality standards that apply to compounded drugs?

>> Gail Bormel: Sure. Drugs that are compounded in outsourcing facilities are subject to FDA quality standards from manufacturers known as good manufacturing practice requirements. By contrast, drugs that are compounded in a state licensed pharmacy may be subject to less stringent quality standards that are set in state law or by policy. These standards may differ from one state to another.

>> Anand Shah: In the intro, we briefly mentioned the Compounding Quality Center of Excellence. Can you tell us a little bit about that and what kind of activities or training the FDA recommends that compounding facilities undertake?

>> Gail Bormel: Sure. The FDA's Compounding Quality Center of Excellence, or the CQCOE, as we call it, is focused on improving the quality of compounded drugs, primarily those made at outsourcing facilities. The CQCOE explores new ways to engage and collaborate with outsourcing facilities, including current good manufacturing practice requirements training, which is intended to improve the overall quality of compounded drugs. This is particularly important for outsourcing facilities because their compounded drugs reach many patients across the country, and the ongoing training aims to enhance understanding of and adherence to these quality standards and designed to improve the overall quality of compounded drugs for patients who need them.

We have trainings as part of this program that are all virtual and free for participants, and they include both instructor-led and self-guided options. Recently, the Compounding Quality Center of Excellence hosted its first virtual conference to bring together current and future outsourcing facilities, regulators, and other compounding experts and stakeholders to discuss key topics and best practices. We plan to hold a second virtual conference in the coming year.

>> Anand Shah: This is really great. Let's pivot here to COVID-19. How has compounding come into play during the pandemic?

>> Gail Bormel: Compounding has come into play during the COVID-19 crisis and it has played a pivotal role in the fight against COVID-19. For example, we issued several temporary guidances related to human drug compounding and repackaging to help address drug supply interruptions and other risks related to COVID-19. Our guidances aim to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients. An example of the guidances that we issue are those temporary guidances to help address supply disruptions of certain FDA approved drugs used for hospitalized patients with COVID-19 and a guidance on the compounding of hand sanitizers.

>> Anand Shah: Let's put all this in context for the consumer and the patient. What does all this mean for the public?

>> Gail Bormel: We must continue to work together to protect patients from the risks associated with poorly compounded, contaminated, or otherwise harmful drugs, while ensuring appropriate access for the patients who need compounded medicines. We are focusing our efforts on improving the quality of compounded drugs, especially those made at outsourcing facilities, to address the need for and safety of compounded drugs. We consider this to be a shared responsibility among the companies who are making the compounded drug products, FDA, and other stakeholders.

>> Anand Shah: Ms. Bormel, as we wrap up, I want to thank you for taking the time to join us this week on FDA Insight.

>> Gail Bormel: Well, thank you again for having me. I really enjoyed speaking with you today.

>> Anand Shah: In the weeks ahead, we'll be covering a variety of topics that are important to public health.

As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow.

We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcasts, Google Podcasts, Spotify and Pandora. Thanks for listening.

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