Federal Safeguards Against Drug Shortages

Nina Ordinario
Associate Editor
Loyola University Chicago School of Law, JD 2024

From October 2022 to January 2023, there was a nationwide Adderall shortage. This recent shortage is no surprise since the Food and Drug Administration (FDA) has announced several Adderall shortages since 2019. Although the recent shortage has ended, researchers fear there will be more Adderall shortages in the coming year as prescribing rates continue to rise. More importantly, the recent shortage has made patients worried about future shortages and concerned about why the federal government has not done more to prevent drug shortages.

What causes drug shortages

Drug shortages can significantly impact public health, and it is a complex issue involving various stakeholders, including manufacturers, wholesalers, distributors, regulators, and healthcare providers. Drug shortages can occur for various reasons, including manufacturing and quality control issues, supply chain disruptions, and increased demand. However, the federal government has limited control over many of these factors, and some underlying causes may be outside its jurisdiction. Further, the pharmaceutical industry is highly complex, and various market forces can impact drug availability. Even if a pharmaceutical company is willing to produce more of a drug, there may be limits to its manufacturing capacity. For example, expanding production may require significant investments in facilities and personnel, and the process may take time. As another example, because pharmaceutical companies operate in a competitive market, they must balance the cost of producing drugs with the demand for those drugs. A company may decide not to produce more supply if there is insufficient demand for a particular drug.

The federal government’s limited control

Although the FDA can regulate the pharmaceutical industry, it is not authorized to require pharmaceutical companies to produce more drugs under the Food, Drug, and Cosmetic Act (FDCA). Instead, the FDA has initiated several solutions attempting to prevent or mitigate drug shortages. For example, the 2012 FDA Safety and Innovation Act (FDASIA) requires manufacturers to notify the FDA of any anticipated supply disruptions or discontinuations of drugs that are critical to public health. These notifications allow the FDA to become appraised of potential drug shortages sooner so that it may work with the company to mitigate the drug shortage and promptly notify the public of any shortages. The notification requirements were further expanded by the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act), requiring companies to notify the FDA of permanent discontinuances or interruptions in manufacturing products and ingredients and the reasons for the discontinuances or interruptions.

In addition, the FDA established the Agency Drug Shortages Task Force in 2018 to investigate the causes of drug shortages and identify solutions. In 2019, the Task Force released a report which identified root causes for drug shortages and recommended solutions. Notably, the Task Force recommended that the federal government establish more incentives for manufacturers to produce less profitable drugs, such as generic drugs.

Further, the FDA can expedite reviews for companies who want to increase the production of new or alternative sources of drugs in short supply. The FDA can also extend product expiration dates or increase imported medicines to the United States. Expedited reviews, extending product expiration dates increasing imports are just a few ways in which the FDA can introduce more drugs into the market to offset drug shortages.

Preventing future Adderall shortages

In light of the federal actions described above, drugs such as Adderall remain in shortage. Teva Pharmaceutical Industries Ltd., the largest producer of Adderall, announced that the shortages were due to labor and staffing shortages. However, others suggest that the Drug Enforcement Administration (DEA) is to blame. The DEA designates Adderall as a Schedule 2 controlled substance. Thus, the DEA has the authority to limit the number of ingredients that manufacturers receive and how much product manufacturers can produce each year. In addition, despite the recent shortage, the DEA announced in December 2022 that it would not increase the manufacturing quotas for the upcoming year. These quotas directly impact how much drugs, like Adderall, each pharmaceutical company can manufacture and distribute. Accordingly, as Adderall prescription rates continue to rise, pharmaceutical companies will likely continue to struggle to meet the market’s demand.

In an attempt to address these issues, Congresswoman Abigail Spanberger has suggested that the DEA and FDA take a collaborative approach to combat future Adderall shortages. In addition, Congresswoman Spanberger has requested that the DEA and FDA release information on how they plan to alleviate the shortage. As a similar recommendation, perhaps the FDA can initiate a task force dedicated to investigating the manufacturing practices among companies that produce Adderall. Additionally, the FDA could sponsor research studies to predict what the Adderall prescribing rates and market demand will look like in the upcoming years. This data could help the DEA establish future quotas for higher production rates.

Although the recent Adderall shortage has passed, researchers believe that there will likely be more Adderall shortages in the future if prescribing rates continue to rise. Although the federal government has taken several actions toward addressing drug shortages generally, perhaps it needs to dedicate resources specifically to researching Adderall shortages. Taking specific steps towards investigating Adderall shortages may lead to targeted solutions that can address unique challenges among Adderall manufacturers.