FDA Monitoring Drug Shortages and Fraudulent Claims Regarding Coronavirus

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With the coronavirus death count over 2,700 worldwide and the U.S. Centers for Disease Control & Prevention (CDC) warning it will likely become much worse in the U.S., the U.S. Food and Drug Administration (FDA) is increasing its vigilance. The agency announced yesterday that it is monitoring the market for possible drug shortages, as well as keeping an eye on fraudulent treatment claims.

It was reported on Monday that the FDA is compiling a list of drugs that are at risk of shortage if the outbreak in China continues to worsen. There are indications that about 150 prescription drugs could be affected, ranging from antibiotics to generic drugs, with potentially some branded drugs.

Because China is a major supplier of ingredients used to manufacture many drugs sold in the U.S., this could have a major ripple effect in the U.S. and around the world.

The agency has identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China. The agency has reached out to more than 180 drug manufacturers since Jan. 24 to remind them to notify the agency if there are any expected supply disruptions.

“None of these firms has reported any shortage to date,” said FDA spokesperson Stephanie Caccomo. “We will continue to remain in contact with the manufacturers so that we can best help mitigate any potential issues in the future.”

The FDA is also in touch with hundreds of drug and medical device manufacturers and is coordinating with other global regulators, like the European Medicines Agency. The agency notes that no vaccines, gene therapies or blood derivatives the FDA licenses are manufactured in China, although some raw materials for those products come from China or other southeastern Asian countries.

However, in a statement on Monday, the FDA indicated that because of a State Department travel advisory, it hasn’t conducted any inspections in China recently. It states it is conducting inspections using other methods, including document requests in lieu of drug surveillance inspections.

About 60% of FDA-regulated products imported from China are medical devices and 20% are housewares, according to the FDA. There is no evidence of increased health risk from imported products.

“As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed,” stated FDA commissioner Stephen Hahn.

The agency is also monitoring the market for fraudulent claims for prevention and treatment of the coronavirus. It will enforce this using “warning letters, seizures, or injunctions against products on the market that are not in compliance with the law.”

The FDA warning followed Amazon removing listings from its websites that claim to help stop the spread of the virus.

The agency issued a statement on Friday outlining what the agency is doing at home and abroad in response to the outbreak.

“The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts,” Hahn wrote.

The agency is taking four major steps. First, active supply chain surveillance. “We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages,” Hahn wrote.

Secondly, the agency is inspecting, and monitoring compliance of FDA products manufactured overseas. Hahn notes that “FDA inspections are used as part of our commitment to the supply chain and are currently continuing as normal except in China consistent with the State Department Travel Warning. Any travel to China which is deemed to be mission-critical is being assessed on a case-by-case basis in close coordination with HHS and the State Department.”

The agency notes it runs about 500 inspections annually in China with most being for drugs, foods and medical devices. They are not currently running any because of the State Department warning.

Third, the agency oversees the safety of consumer products that come into the U.S. from other countries. They are all subject to the regulatory requirement U.S. Customs and Border Protection (CBP), which then refers FDA-regulated products to the FDA for review. If anything is considered higher risk or the paperwork is incomplete or inaccurate, it is flagged for manual review by the FDA.

“Again,” Hahn wrote, “we want to reassure the public that at this time there is no evidence that food or food packaging have been associated with transmission and no reason to be concerned. Further, there is no evidence to support transmission of COVID-19 associated with imported goods, including food and drugs for humans and pets, and there have not been any cases of COVID-19 in the U.S. associated with imported goods.”

And fourth, the FDA is working to diagnose, treat and prevent the disease. Last week the FDA issued an emergency use authorization (EUA) to allow immediate use of a diagnostic assay developed by the U.S. Centers for Disease Control and Prevention (CDC), which will make it easier for CDC-qualified labs to use the test. The agency has also developed an EUA review template for tests for the virus, which outlines the data requirements for a Pre-EUA package that assay developers can request. So far, more than 50 companies have expressed interest in the EUA review template.

And finally, Hahn notes that the FDA “is closely monitoring the outbreak and collaborating with our interagency partners, international partners, and medical product developers and manufacturers to help advance response efforts to combat this virus.”