Zuhal Reed, Esq. | Risk Management Senior Staff Attorney | Medmarc
The CARES Act, signed into law on March 27, 2021, is aimed at managing the COVID-19 crisis and moderating its economic impact. Section 3112 of the CARES Act enabled FDA to avoid drug shortages by increasing oversight of drug and medical product supply chains. Drug shortages have long been a problem in the United States, however the pandemic spotlighted this issue. For example, throughout the pandemic, doctors found themselves trying to decide if certain drugs in short supply should be used for chemotherapy or for COVID-19 patients experiencing severe inflammation. Some critics argue that these issues may have been better managed with greater FDA oversight and coordination between drug manufacturers and FDA.
The new reporting requirements under section 3112 have created additional responsibilities for certain drug manufacturers, which are now responsible for informing FDA of permanent discontinuances and interruptions in manufacturing. They are also responsible for creating a risk management plan to identify and evaluate risks to the supply chain.
To facilitate the reporting of this information, FDA launched the NextGen Portal, along with two guidance documents intended to help manufacturers comply with reporting requirements. There are timing requirements for the reports as well. The reports must be submitted by February 15, 2022 for information from the 2020 calendar year and must be submitted by May 16, 2022 for 2021. The two guidance documents advise on reporting requirements, the process for submitting reports, technical details related to conformance of the report, and the data requirements for the reports. Further, FDA has created videos and guides to aid manufacturers in utilizing their NextGen Portal for quick and efficient reporting.
Monitoring this data will invariably allow FDA to mitigate and prevent shortage of drugs that could create a public health crisis. Compliance with these new requirements will be key to avoiding some of the issues we encountered during the COVID-19 crisis.
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