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FDA Insight: Episode 10 – Transcript

>> Anand Shah: Hello, and welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here the FDA. Thank you for joining us for another great episode. This week will be discussing drug shortages. My guest today is Valerie Jensen, a recently retired member of the U.S. Public Health Service Commission Corps and also Associate Director of the Drug Shortages staff in FDA's Center for Drug Evaluation and Research, or CDER. Val, welcome to FDA Insight.

>> Valerie Jensen: Thank you so much for having me, Dr. Shah, it's great to be here.

>> Anand Shah: It's great to have you. Well, let's jump right in. Many Americans take daily medications to manage their chronic diseases. What medication shortages should consumers be aware of due to the pandemic?

>> Valerie Jensen: Most shortages, historically, have really involved sterile, injectable drugs, and especially older sterile, injectable drugs. And so, those are drugs that are used by hospitalized patients, and especially right now during the COVID-19 pandemic, these shortages have been exacerbated really by increased demand and increased hospitalization, so that's really been one large concern. And then the other piece is that there are actually recent shortages that are impacting patients when they go to the pharmacy. So, drugs like drugs for high blood pressure and also drugs for treatment of heartburn, those have been in shortage. So, there's also been some recent shortages of antibiotics that are absolutely needed for bacterial infections.

>> Anand Shah: So, what causes these drug shortages?

>> Valerie Jensen: So, a variety of reasons cause shortages. The main reason through the years, the main issue is really the manufacturing and quality problems. So, issues at the manufacturing plant, and especially for these older drugs that I mentioned — so sometimes, those manufacturing sites are older, and they've been in need of upgrades. Sometimes there are older processes involved, older equipment, and so that's been our main reason. But then recently, of course due to COVID-19, we've had the increasing demand for certain medications, and then we've also had increase in hospitalizations, which has drained the supply. Patients wanting to stock up, and that's a normal reaction — that's been another reason. And then sometimes, we've had some cases of slower manufacturing times due to labor shortages in some of the areas that have been harder hit.

>> Anand Shah: What's the role of FDA in preventing, preparing, and responding to drug shortages?

>> Valerie Jensen: Absolutely, so manufacturers are required to notify us when there's some type of supply disruption that's anticipated. Of course, we work very closely with the manufacturers as soon as we hear about those disruptions or those potential disruptions, and our goal is really to prevent shortages. We've also really — in relation to COVID-19, we've been watching the medical supply chain very closely. And for example, we've continued to — since January, we've been in contact with over 180 drug manufacturers and we're reminding them to look at their entire supply chain and make sure that they have enough active ingredients, they have enough components, and then making sure that they notify of us of any time that there's going to be any potential supply disruption so we can work with them. And then I just wanted to mention that all current shortages, as well as resolved shortages and discontinuations, are posted on our FDA drug shortage website, so we keep up-to-date info there on supply information for both healthcare professionals and patients.

>> Anand Shah: That's great. You know, speaking of patients and consumers, what exactly should consumers do to ensure they have sufficient medication supplies during quarantine periods?

>> Valerie Jensen: Yeah, absolutely. So we remind patients and we are in contact with patients that they should keep taking all their medications exactly as prescribed and have enough on hand. And then also talking to their health care provider, their doctor -- if there is any disruption, if they're having any difficulty -- talk about alternatives, potential alternatives that could be used temporarily until their medications' back in stock. And then we also ask that people call the pharmacy ahead of time to check if the medication is available at that pharmacy. What we've noticed, even in recent months with COVID-19 demand, sometimes one pharmacy would be out of the product and then the other pharmacies in the area are well-stocked, and there've been these regional and local disruptions. And so, we just remind patients that they can check more than one pharmacy as well.

>> Anand Shah: So, Val, if I'm at Walgreens, which medications should I look for and have on hand during the COVID-19 pandemic?

>> Valerie Jensen: Sure, and I'm a pharmacist by training, so I would just say patients should always have the regular medications of course and have a good supply of those. They don't need to overstock, but just to have a sufficient supply. And then as well, it's always good to have over-the-counter medications such as medicines that treat fever and cough and other symptoms in case a patient gets sick. And we'd also advise that a thermometer is a good idea to have around as well.

>> Anand Shah: So many of these drugs are made in foreign countries. How does FDA ensure the quality of these medications?

>> Valerie Jensen: Yeah, the FDA use a risk-based approach to ensure quality, and that can include several measures; it does include several measures. So import screening at the border, screening of shipments, and examinations, as well as sampling of those shipments, and then import alerts. And really, what FDA is looking at is we're relying on the previous compliance history, so their inspectional history. And then we also monitor the global drug supply chain and prioritize risk-based inspections in other parts of the world. And one question that we've continued to get, and this coming is from consumers, and people are concerned that there could be a risk of COVID-19 transmission with imports. There's no current evidence to support that. So it's something we've been asked, and it's absolutely there's no evidence to support that.

>> Anand Shah: That's great to hear. Do consumers have the option to buy American when it comes to medications?

>> Valerie Jensen: That's another good question that continues to come up, and what we would say — so regardless of where a drug is made, so if it's a drug that's sold in the U.S., it must comply with our FDA rules and regulations and it must be deemed safe and effective. It's not always easy for consumers, if you're looking at your drug package or your prescription, to determine where the product is manufactured. And one thing we should note is that our industry depends on access to supply from a diversity of sources, so some components might be made in one area and then ingredients in another. One thing to note though, if a supply issue does occur and the company needs to qualify a new supplier or new manufacturing site, FDA will expedite review to prevent shortages.

>> Anand Shah: Commissioner Hahn recently wrote about how investing in domestic advanced manufacturing can help address drug shortages. Can you tell us a little bit about what advanced manufacturing is and how it can strengthen our pharmaceutical supply chain?

>> Valerie Jensen: Yeah, absolutely. So as I mentioned earlier, the shortages that we really have seen historically have mostly been caused by supply disruptions and due to quality problems. And so those quality problems are often related to older facilities, older processes, the equipment sometimes is older and more prone to quality lapses. So advanced manufacturing is really a collective term for new product — new medical product manufacturing technology. So really, we're looking at new technology that can improve the quality, and we also expect that to address drug shortages. We'd expect that to speed the time to market for needed medications as well. So it's — advanced manufacturing really, we'd see that as enabling innovation, increasing efficiency, and improving supply chain resiliency for medical products. So it's really something that we see as a large public health gain, and it's something that we continue to encourage industry to do.

>> Anand Shah: Val, you've shared a ton of helpful info for our listeners. As we wrap up, I want to thank you for taking the time to join us this week on FDA Insight.

>> Valerie Jensen: Thank you again, Dr. Shah, for having me on the show today.

>> Anand Shah: In future episodes, we'll be discussing a wide variety of topics including opioids, tobacco, and nutrition. 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 and Google Podcasts. We're also on Spotify and Pandora now, so whatever platform you're on, thanks for listening.

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