FDA Acknowledges Coronavirus Is Causing More Drug Shortages
The first outbreak of the coronavirus occurred in China nearly two months ago. The disease quickly spread through the country. As of March 5th, the coronavirus is responsible for over 80,000 confirmed cases and nearly 3,400 deaths across China. Globally over 98,000 people are infected, resulting in nearly 4,000 deaths.
At this time, the United States reports 230 confirmed cases and 12 deaths. And the effects of the virus extend well beyond public health. Fear of a nationwide outbreak has negatively impacted financial markets, motivating the Federal Reserve to cut interest rates. Numerous flights are canceled until further notice. Stores are running out of hand sanitizer, bottled water, and other emergency goods.
But the most concerning shortage stemming from the coronavirus is for medicines. The Food and Drug Administration recently announced the “COVID-19 [coronavirus] outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.” The agency hasn’t identified which drugs are or will likely be affected. However, it assures us that it will work with manufacturers to mitigate supply-chain disruptions.
Many worry about how our healthcare system will handle a potential epidemic. They should also be concerned about how the FDA will handle these drug shortages. History is not on the agency’s side.
After Hurricane Maria left much of Puerto Rico devastated in 2017, then FDA Commissioner Scott Gottlieb noted the hurricane caused shortages for nearly 90 medical products, including for about 40 pharmaceuticals in the United States. IV-saline bags, which are commonly produced in Puerto Rico, remained in short supply in U.S. hospitals over a year after the storm.
Supply-chain issues coming from infected countries like China, which produces a considerable amount of the pharmaceuticals and medical supplies bound for United States (including 97 percent of U.S. antibiotics) would be a much more difficult and time-consuming problem.
Drug shortages also occur in the United States without pandemics or natural disasters. Many hospitals are consistently low on hundreds of drugs critical for treating patients. Similar concerns extend back almost twenty years.
As I have noted in a previous post, shortages in healthcare markets occur for a variety of reasons. Consistent shortages are nearly always because of regulation.
Drugs imported from foreign countries face considerable barriers before they can reach U.S. patients. In addition to meeting the onerous requirements of FDA approval process, imported drugs must meet additional manufacturing and labeling requirements. Differences in international production and labeling standards can lead the FDA to issue an import alert. Import alerts ensure “future shipments of that product will not be allowed to enter the United States, unless the importer demonstrates that the product is in compliance.” Demonstrating compliance after an alert can take months.
With the FDA withdrawing inspectors from China to prevent the disease from spreading, it seems shortages are only a matter of time. Our best chance to mitigate them is to reduce imported drug restrictions. We can all be confident that, eventually, the coronavirus will be contained. I wish we could say the same for drug shortages.