Drug shortages can happen for a plethora of reasons, but sometimes there’s a “gap in knowledge” between manufacturers and regulatory agencies, according to FDA expert Emily Thakur.
Ms. Thakur, team leader of the agency’s drug shortage staff and a registered pharmacist, answered six common questions about drug shortages in a March 13 post.
Here are the six questions and her abridged answers:
Question: What are the main causes of drug shortages?
Emily Thakur: “There are many contributing factors. Manufacturing quality issues are the major reason for drug shortages. However, there are other reasons, such as manufacturing production delays. For example, companies have experienced lags in receiving raw materials and components from suppliers. Discontinuations of drug products are another factor contributing to shortages. FDA can’t require a firm to keep making a drug it wants to discontinue. Sometimes companies discontinue older drugs in favor of newer, more profitable ones.”
Another potential catalyst for drug supply issues is when fewer companies are making a drug, thus limiting the number of available production lines, she said. Suppliers are also limited in how many components they can make because of capacity rules, and manufacturing complexities can make some drugs “vulnerable to shortage,” according to Ms. Thakur.
Q: How does [the Center for Drug Evaluation and Research] help manufacturers rectify or avoid drug supply and shortage situations?
ET: “FDA takes great efforts, within its legal authority, to address and prevent drug shortages and supply issues. CDER uses a variety of tools to monitor the supply chain. CDER does not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug. But we can help encourage companies to do so. For example, due to the COVID-19 pandemic, [the FDA Drug Shortage Staff] asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients and finished dose forms.”
She cited the recent examples of ibuprofen and acetaminophen shortages. In January, the FDA issued a guidance to help boost supply by allowing hospitals and health systems to compound some forms of the products.
Q: Do drug manufacturers have requirements regarding working with CDER to reduce or avoid drug shortages?
ET: “It is the drug manufacturers’ responsibility to provide FDA with certain information related to potential supply disruptions, and we work closely with manufacturers to prevent or reduce the impact of shortages that may result.” The FDA is authorized to “identify, prevent and mitigate possible shortages of drugs by, among other things, enhancing our visibility into the drug and medical product supply chains.”
These include notifications of permanent discontinuances and interruptions in the manufacturing of active pharmaceutical ingredients, making risk management plans, and reporting the amount of listed drugs and biological products manufactured.
Q: Recently there seem to be many drug shortages and drug supply issues. Is this the case and if so, why?
ET: “Drug shortages aren’t uncommon. However, the triple threat of COVID-19, respiratory syncytial virus and influenza is beyond what anyone could have predicted.” Labor issues have also sprung up recently, and drug supply issues usually crop up during winter, Ms. Thakur said.
“Although the majority of shortages are caused by manufacturing issues, we have also seen some shortages due to increases in demand. Manufacturers are required to notify FDA of permanent discontinuances and certain interruptions in manufacturing, but not necessarily when they are seeing an increase in demand. That gap in knowledge can sometimes lead to shortages that the agency can’t address preventatively. But whether it’s the recent triple threat, increases in demand, or another issue, our team’s strategy is the same: We work closely with drug manufacturers to communicate issues and to help restore availability.”
Q: When and how are drugs added to the drug shortage list?
ET: “Drug manufacturers have been required to notify FDA of changes in the production of certain finished drugs that may, in turn, help the agency in its efforts to prevent and mitigate shortages. When [the FDA Drug Shortage Staff] confirms a drug shortage exists, we post this information on the Drug Shortages website. We update the drug shortage list daily with new and resolved shortages, as well as additional information we receive from suppliers on their manufacturing capacity.”
Q: Is there a way to resolve drug shortage and supply issues? Can you offer any solutions?
ET: She said her team decides how to address each shortage by looking at its cause and any public health risks related to the supply issue.
“The agency also works with other firms making the drugs in shortage to help them ramp up production if they are willing and able to do so. Often, they need new production lines or new raw material sources approved to help increase supplies. We expedite review of these to help resolve shortages of medically necessary drugs. We can’t require the other firms to increase production, but we do all we can, within our authority, to mitigate shortages — ideally before they occur.”
Read another perspective on drug shortages here.