Colleen Labbe: Hello, I'm Colleen Labbe, with CDER’s Office of Communications. Drug shortages have a significant impact on both hospitals and patients. Supplies may have to be rationed and treatment plans may need to be altered, both of which can compromise patient care. Today, I'm talking with Dr. Janet Woodcock to learn more about what the agency is doing to address the issue of drug shortages and how the agency is working with industry to help lessen their impact. Welcome Dr. Woodcock.
Dr. Janet Woodcock: Thank you.
Colleen Labbe: So, what are some of the more notable drug shortages that we've had recently?
Dr. Janet Woodcock: Well, drug shortages very unfortunately happen on a regular basis, but we've seen a number of really critical drug shortages recently that have gotten the attention in the health care community. For example, IV fluids or what we call large volume parenterals, they've been in shortage on and off since 2014 but, in 2017, after the hurricane in Puerto Rico, where most of IV fluids were manufactured, we saw really serious shortages. And FDA had been working with various manufacturers to help improve the supply of these products and we're making progress in having multiple sites and more robustness of supply. Another critical shortage has been injectable opioid analgesics, which are used to treat severe pain often in hospitals in the setting of surgery or other procedures and so forth. This shortage has mainly been due to production delays and quality control issues at the manufacturer's plant because there was one primary manufacturer. And then the EpiPen, which everyone knows about ,I think, which is an auto-injectable epinephrine product that many people rely on to treat life threatening allergic reactions. There are multiple production issues that caused the supply problems and we're working with the manufacturer to resolve them as quickly as possible. We also recently approved a new generic form of the product and there are actually other types of epinephrine products on the market that can be injected. And after working with the EpiPen manufacturer to make sure that it would be safe and remain effective, we were able to extend the expiry date of EpiPens by 4 months to take some pressure off of the supply issue.
Colleen Labbe: Okay. What are the typical causes of drug shortages?
Dr. Janet Woodcock: Well, there's several main reasons for drug shortages. The primary one is disruption in the supply chain, and by supply chain we mean all the things leading up to that drug appearing in the hospital pharmacy or the outpatient pharmacy. And these supply chain issues include problems with manufacturing and problems with quality control of the manufacturing. Also, sometimes we see lack of availability of raw materials. So if one raw material supplier where that raw material is critical and might be a single supplier, could affect production for a lot of drug makers and lead to widespread shortages. An unforeseen increase in clinical demand such as suddenly, clinical practice guideline changes and demand surges or even if FDA approves a new indication for an existing drug, you may see a shortage of that specific drug. And rarely but sometimes, we see manufacturers simply discontinuing their product. This is often made for business reasons, whether the drug is still profitable, it's too expensive to manufacture and so forth and so on. Typically, only a small percentage of shortages each year result from this kind of discontinuation.
Colleen Labbe: How is the agency currently addressing the issue?
Dr. Janet Woodcock: Well, we can and do take several actions to help mitigate shortages. We can expedite inspection of facilities and assessment of drug applications for drug makers that want to produce the drugs in short supply so they can become operational as soon as possible, and we also expedite the review of a newer generic drug application that could be an alternative to the one that's in shortage. We can't force or mandate submission of applications for products in short supply. Often the public calls upon us to do that but that's not something that's within our power. If we can know about other manufacturers, we alert other manufacturers of similar products or alternatives and we ask them to ramp up their production. So, we do that. For shortages, it can't be resolved quickly but with current manufacturers we sometimes work with manufacturers overseas to temporarily import drugs in shortage to help meet patient needs until the shortage is resolved. But before we begin that importing, allowing it, we carefully evaluate the overseas product and the manufacturer to make sure that it's safe and fit for purpose in the United States. We have the most success in all of this by working closely with manufacturers to help prevent shortages actually before they occur. This means we need to know about potential supply disruption before it happens, not when hospitals start calling us. The Food and Drug Administration Safety and Innovation Act of 2012 known as FDASIA, generally requires manufacturers to notify us of any disruptions including manufacturing changes, production or shipping delays and product discontinuations, you know, in advance if they know about them. And this would allow the FDA to execute other actions that could avert impending shortages or lessen their impact.
Colleen Labbe: So, what can industry do to help alleviate the issue?
Dr. Janet Woodcock: Well, we still see that sometimes manufacturers abruptly discontinue, limit or delay production. They may have some other product they want to produce more of or what have you. That can, for a product where there aren't alternatives, it can throw the health care system into turmoil. Other times companies may notify the FDA of potential supply disruptions but we don't have enough details to fully address the shortage, and this can delay us taking effective action. So we need to know specifically what's going to happen, whatever industry knows at the time. So, they can help by sharing vital information about potential supply disruptions in a timely manner. The more information we have, the more we can try to prevent and head off a shortage. And given the complexities involved in drug manufacturing, problems can arise at any point in the process. If companies are proactive and especially for critical drugs have backup plans and facilities and raw materials suppliers are prepared for when things go wrong, then everybody can help avert shortages better.
Colleen Labbe: What are new ideas we are considering to improve the drug shortages problem?
Dr. Janet Woodcock: Well, we're currently evaluating our authorities under FDASIA to see if we can do more to better address shortages. For example, do we have the ability to require applicants of certain drugs to identify any risks or vulnerabilities in their drug supply chain and actually develop risk management plans so that there's a plan in advance in case something happens? With these contingency plans in place, shortages can be more easily managed and resolved, doing this work up front rather than when you're facing a crisis. We also have been encouraging the adoption of new technology, such as continuous manufacturing, that reduce supply disruptions. Our emerging technology program team works with drug makers to develop and implement these new technologies. But we can't require that manufacturers increase production of a drug in shortage, and we don't have control over business decisions that affect the supply chain. But we can all work together to minimize disruptions and lessen the impact of drug shortages on our patients.
Colleen Labbe: For sure. Dr. Woodcock, thanks very much. It's always a pleasure speaking with you.
Dr. Janet Woodcock: Thank you.
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