FDA Provides Coronavirus Supply Chain Update

As the FDA closely monitors the coronavirus supply chain, it has uncovered a drug shortage related to a site affected by the coronavirus, or COVID-19, according to a recent statement from Stephen M. Hahn, MD. 

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As the COVID-19 outbreak continues to threaten the medical product supply chain, Hahn stressed that the FDA has monitored any potential disruptions by keeping in touch with more than 180 manufacturers since late January. 

The FDA recently identified a shortage of a human drug. The human drug shortage is linked to a shortage of a vital, active ingredient used to create the drug, the manufacturer told the FDA. But Hahn assured the industry that there are other alternatives available. 

"We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage,” he explained. 

Manufacturers were asked to evaluate their entire supply chain and notify the FDA over any potential supply disruptions, such as active pharmaceutical ingredients and various components manufactured in China. 

So far, the FDA has identified nearly 20 drugs based solely out of China. 

“We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date. Also, these drugs are considered non-critical drugs,” Hahn stressed.

“We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way.”

Medical devices are also at risk during this disease outbreak. The FDA is aware of 63 manufacturers that represent 72 facilities in China that produce crucial medical devices and contacted them individually. 

Many of the manufacturers have reported a slow down in production due to challenges including necessary quarantine of workers. But, there are currently no reported shortages for these medical devices within the US market. 

Due to the fast outbreak of COVID-19, personal protective equipment such as surgical gowns, gloves, masks, respirator protective devices, and other medical equipment have been in high demand.  However, the FDA is not aware of any supply shortages of medical devices.

“We are aware of reports from CDC and other US partners of increased ordering of a range of human medical products through distributors as some healthcare facilities in the US are preparing for potential needs if the outbreak becomes severe,” Hahn said. 

Although there is no law that requires medical device manufacturers to keep in contact with the FDA and notify them about shortages, the FDA has attempted to stay in contact with hospitals and has encouraged healthcare facilities to report disruption by its mailbox, which is a “valuable surveillance resource” to enhance FDA efforts. 

The FDA voiced that it does not know of any cellular or gene therapies that are made in China for US use and there are no reported shortages of biologics at this time. 

There have been no reported cases of transfusion-transmitted COVID-19, but despite this, the FDA has continued to make information available to blood establishments that manufacturer human cells, tissues, or cellular or tissue-based products. 

“These establishments may wish to consider additional donor screening measures in response to the COVID-19 outbreak,” Hahn said. 

There are no reported shortages for food but Hahn stressed that it is important to practice good hygiene when handling or preparing foods. Similarly, there are also no reported shortages for animal drugs. But six animal drug firms are currently looking at disruptions in the medical product supply chain that may lead to shortages in the future.

The FDA is working with these firms to identify interventions to stop potential shortages.

As the FDA continues to tackle the COVID-19 outbreak, there were four specific proposals included in the President’s budget that would better equip the FDA to prevent medical product shortages:

• Lengthen expiration dates to mitigate critical human drug shortages
• Improve critical infrastructure by requiring risk management plans
• Improve critical infrastructure through improved data sharing and more accurate information
• Establish reporting requirements for device manufacturers

Lengthening the expiration dates to stop human drug shortages is scientifically justified and could lead to more supply available to alleviate the drug shortage or severity of a shortage, the agency maintains. And a requirement of risk management plans would allow the FDA to strengthen the supply chain by integrating contingencies for emergency situations, Hahn emphasized. 

More accurate and timely supply chain monitoring would also improve the agency’s ability to recognize shortage signals. Ensuring the FDA requires information to assess critical infrastructure and improving data sharing can make these improvements. 

A medical device manufacturer is not required to notify the FDA when a shortage is on the rise, so by allowing the FDA to access accurate information could ensure steps to promote availability to devices of public health importance.

Hahn stressed that the FDA will continue to monitor the medical product market and use its authority to combat any “bad actors” that use this outbreak to their advantage and deceive the public. This includes warning letters, seizures, or injections against products on the market that are not approved or against firms or individuals who violate the law. 

The FDA will also continue to monitor and tackle coronavirus issues in the coming months through partnerships with federal partners, international regulators, and medical product developers. 

“The FDA is using all our existing authorities to address COVID-19, and we welcome the opportunity to work with Congress to further strengthen our response capabilities and emergency preparedness,” Hahn concluded.