Last week the FDA posted new guidance called “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency” that directly addresses everything I talked about in my last essay, “DSCSA Exemption For Public Health Emergencies” and more. This new guidance was “fast-tracked” and went direct to “final” status, skipping the “draft” stage used for most guidances. The FDA determined that the “…prior public participation for this guidance is not feasible or appropriate.” Things are moving fast at the FDA regarding Covid-19 so if you’re reading this essay more than a week or two after it is published, I suggest you search the FDA website to confirm that its contents are still fully valid. Make sure you check the links below for more info.Continue reading FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE
On March 10, 2020, Alex M. Azar II, Secretary of Health and Human Services of the US government, declared a public health emergency (PHE) under Section 319F of the Public Health Service Act “…to provide liability immunity for activities related to medical countermeasures against COVID-19.” This action immediately opened an exemption embedded in the Drug Supply Chain Security Act (DSCSA) for the “covered persons” performing the “covered countermeasures” aimed at the specific “threat” in the covered “geographic area”, for the identified “population” for the “effective time period” specifically identified in the declaration.
This is only the second public health emergency with nationwide scale announced in at least the last 20 years. The first was for the opioid crisis. The intent of these declarations is to lower the liability exposure to companies helping to create, distribute and administer countermeasures aimed at ending the emergency. Let’s take a closer look at the effect of the Covid-19 PHE on the DSCSA and companies in the US pharma supply chain.Continue reading DSCSA Exemption For Public Health Emergencies