FDA Moves to Ease Covid-19 Drug Shortages

By Walter F. Roche Jr.

The U.S. Food and Drug Administration has issued an emergency advisory indicating it will, in effect, temporarily ease requirements for drug compounding firms to produce drugs being used to treat victims of the Covid-19 pandemic.
In a 16-page document, known technically as a "guidance," the FDA said it does not intend to enforce restrictions that currently bar drug compounders from producing drugs that are not on an official drug shortage list.
Citing complaints from hospitals and other providers that drugs needed to treat Covid-19 patients are not available, the guidance states that it does not intend to enforce the existing restrictions for some 13 drug products including midazolam, fentanyl citrate, lorazepam and verconium bromide.
"In light of the unprecedented disruption to, and demands on the global pharmaceutical supply chain as a result of the Covid-19 pandemic, additional flexibility is needed to ensure that treatment options are available when hospitals are unable to obtain FDA approved drugs," the guidance states.
The guidance applies to a new class of drug makers known as outsourcers created in legislation passed by Congress in response to the deadly 2012 fungal meningitis outbreak.
Citing the ongoing health emergency, the FDA said it was issuing the new guidance without first seeking public comment, which is the normal process.
Stating the the drugs in question were needed to in-tubate hospitalized Covid-19 patients, the guidance states that the relaxed enforcement policy will only remain in effect during the current public health emergency.
The guidance does set some minimum requirements drug compounders must meet in producing the Covid-19 drugs relating to beyond use dates and stability testing.
The drugs also must be provided directly to a hospital.
Ironically some of the drugs now on short supply for Covid-19 patients are also used by states like Tennessee in the execution of prisoners on death row. Those include midazolam and vercuronium bromide.
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