FDA’s Actions to Drug Shortages
A growing concern during COVID-19 pandemic
Drug shortages used to be a common issue that pharmacists dealt with daily. I remember physicians and nurses frustrated for the lack of vital saline solutions or anesthetics, and parents forced to drive to other counties to find the epinephrine that allowed their kids to return to school.
A growing concern in the past decade, the shortage of essential medications reached an alarming peak in 2011, the year that signaled the turning point for legislators. In 2012, President Obama signed an executive order to reduce the prescription drug shortages, requiring an early notification from manufacturers to report temporary or permanent discontinuation. The notification became mandatory after the congressional approval of the Food and Drug Administration Safety and Innovation Act (FDASIA), which requires at least six months’ notice before the interruption or discontinuance.
Since 2012, the public health system witnessed a decline in drug disruptions, with more alternatives available at affordable costs. In 2018, a new shortage of epinephrine hit the United States. However, this time, the Food and Drug Administration (FDA) collaborated tightly with pharmaceutical companies, expediting the approval for an extended expiration date, and granted approval for new generics.
Once the FDA shifted the drug-supply determination away from manufacturers, they could plan and locate new plants or manufacturing lines, expedite review for increased expiration dates and new raw material sources. The FDA team of experts, the Drug Shortage Staff along with international authorities and other U.S. agencies, facilitates temporary and long-term mitigation strategies to address shortages.¹ Since the FDASIA approval, statistics confirm an increased drug availability, until recently. (Figure 1)
Not more than two months ago, a deadly coronavirus epidemic silently hit a small province of China but spread quickly worldwide, infecting hundreds of thousands. International agencies work around the clock to contain the diffusion of the virus, while single countries assess their emergency plans. A common fear during an epidemic is drug shortages, an event considered by the FDA as a potential threat to the health of millions of Americans. The concern for a coronavirus pandemic unveiled a new challenge for the agency: in a recent congressional testimony, the Director of the Center of Drug Evaluation and Research, Janet Woodcock, provided a detailed picture of the growing dependency of the United States on foreign manufacturers for both active pharmaceutical ingredients and finished medication forms. Today, 72% of the active pharmaceutical ingredients are manufactured overseas, undermining the security of the nation’s drug supply, which relies on the autonomy from foreign sources and the reliability of the national facilities to make the drugs.
Although the novel coronavirus, renamed COVID-19, has not disrupted the supply chain yet, the productivity of the pharmaceutical industry in China has been significantly affected, raising concerns for future drug importations. In a recent press conference, the FDA detailed the plans implemented to address a potential drug shortage, as well as the tools to minimize negative impacts to the public health. The FDA doesn’t have a legal mandate to ask a company to make a specific drug or to produce more drugs; they follow a risk-based framework to monitor the quality of imported drugs, prioritizing inspections and approval for certain medications considered essential. In the past years, during other pandemic emergencies, low quality or counterfeited drugs flooded the market, putting lives at risk. This time, the agency seems well-prepared with efficient countermeasures to protect the public health, such as monitoring on fraudulent products and collaborating closely with firms and online retailers.
There is still more to achieve, but what the FDA has accomplished in promoting the safety, quality, and availability of products to the public is already significant. In the future, the FDA should incentivize new technologies and manufacturing practices to revitalize the drug production in the United States, reducing the dependency from overseas companies.
- U.S. Food & Drug Administration. CE Consultation and Accreditation Web site. Drug Shortages: FDA Efforts, Current Challenges and Future Goals. https://ceportal.fda.gov/. Accessed January 30, 2020
