On May 31, 2018, FDA Commissioner Scott Gottlieb, M.D., released a statement focused on the issue of drug shortages in the United States. Gottlieb highlighted many of the reasons for these shortages, and while he expressed his belief that they are “an inevitable consequence of an imperfect system,” he also laid out the FDA’s plan for preventing them as much as possible.
Gottlieb began his statement by explaining some of the ways in which shortages occur. He stated that many of these shortages happen because of “disruptions in supply chain availability of actively marked products.” This means a product is currently on the market, but for whatever reason, a problem occurs with its manufacturing and/or production process. Often, drug companies that produce medications get their raw materials from multiple suppliers. If one of these suppliers suddenly cannot provide a certain material for the production of the drug, this can lead to serious problems, including an inability for the company to produce more for a certain amount of time. According to Gottlieb, most shortages are caused by a material shortage of this type.
Of course, there are other issues that can lead to shortages, but as Gottlieb stated, these are less common. “Only two percent” of the shortages caused in the U.S. are the consequence of a product discontinuation, which can occur when two companies producing similar drugs merge and get rid of one of the medications. Increases in demand can also bring about a drug shortage, such as when more people suddenly require the drug, when the FDA approves a new version of a drug that already exists, or when the guidelines for clinicians change suddenly, causing a ripple effect. As part of his explanation, Gottlieb outlined the difficulty of predicting every instance that could potentially lead to a drug shortage.
What’s more, the FDA is not imbued with the power to “require a company to produce a drug,” even if it is a necessity for the lives of certain individuals or if the product has experienced an increase in demand. The FDA also cannot force a manufacturer to increase the amount of a drug being created, nor can it control distributions of the drug, including the priority of the drug’s purchasers. Drug manufacturers are businesses, and while the FDA exists to ensure that products created by these businesses are safe and that they provide effective outcomes, the agency is not able to micromanage manufacturers’ business decisions.
Gottlieb also explained where the agency does have jurisdiction. For example, the FDA requires manufacturers to notify the agency of potential disruptions in manufacturing, shipping, production, etc., including delays as well as brief or long-term shut downs. This is covered under the Food and Drug Administration Safety and Innovation Act of 2012. FDASIA requires companies to provide this information when critical, but sometimes, manufacturers are not able to provide the agency with this information quickly enough to stop a shortage. Other times, manufacturers experience changes that are out of their control. There are also situations in which manufacturers are not required to notify the FDA of a possible change. As part of his statement, Gottlieb asked that manufacturers continue to meet the FDA halfway in doing all they can to ensure as much information is passed between the two as possible to help create the most accurate picture of past, current, and future events.
Finally, Gottlieb looked to the future with a promise that the FDA will not only continue to do everything it legally can do—and has done—to fight the potential for drug shortages but that it will also attempt to do more moving forward. Gottlieb stated the agency “may be able to take new steps to clarify the information [it] requires to inform us better about the extent of a shortage problem.” He also mentioned his hope to make communications “more actionable in the future” and to create more possibilities for expediting production when necessary to avoid a shortage. Although the FDA cannot force a manufacturer to take on this problem-solving measure, it can suggest its necessity for helping to avoid a shortage.
In addition, the FDA is implementing new technology in order to prevent the potential for drug shortages in the future. One of these technologies is called continuous manufacturing, which differs from the batch manufacturing that most drug companies utilize currently. The transition can be a difficult one for a manufacturer to make in the beginning, but the benefits in the long-run can be great, especially that of helping to prevent more drug shortages moving forward.
Read the full press release here.