What is the Coronavirus Aid, Relief, and Economic Security (CARES) Act?

The Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed in the USA on March 27, 2020 in response to the economic and public health impact of the COVID-19 pandemic. It aimed to provide financial relief to individuals, businesses, and healthcare systems, as well as to stabilize the economy during the unprecedented disruptions caused by the pandemic. Moreover, the Act also included authorities that intended to help support the US FDA in identifying, preventing, and mitigating potential drug shortages and overall improving the US FDA’s visibility into product supply chains.

What is the significance of the Coronavirus Aid, Relief, and Economic Security Act in the USA’s regulatory landscape?

The CARES Act amended the FD&C Act to elaborate on manufacturer requirements for notifying the FDA about certain drug discontinuances or interruptions in manufacturing that would impact the supply chain in the USA, including the reasons for such interruptions or discontinuances. The US FDA drafted a guidance document to help applicants and manufacturers by providing the US FDA with notifications related to any changes to the production of finished drugs, biological products, and certain APIs. These informative notifications enable the US FDA to assess the situation and conclude on the next steps to prevent drug shortages in the USA.

Furthermore, the CARES Act modified the FD&C Act to mandate that every manufacturer of a drug specified under section 506C(a) of the FD&C Act, as well as manufacturers of any API or related medical devices used for the drug’s preparation/administration, must create, maintain, and implement a redundancy risk management plan . This plan should identify and assess potential supply risks for the drug, as applicable, for each facility where the drug (or its API) is produced.

The FD&C Act was also revised to mandate that anyone registered with the US FDA under section 510 concerning a human or animal drug must annually report to the US FDA the quantity of each listed drug that they manufactured, prepared, propagated, compounded, or processed for commercial distribution.

What are some of the challenges associated with the Coronavirus Aid, Relief, and Economic Security Act?

The FDA rapidly issued new guidance and regulatory updates in response to the CARES Act. Keeping up with these evolving requirements was a significant challenge for third-party agencies that support manufacturers in their compliance efforts. Primarily, it required rapid implementation of complex provisions, creating hurdles to inconsistent interpretation and compliance.

These new regulatory provisions impacted emergency drug approvals, supply chain management, and reporting on shortages. Balancing the urgent need for public health responses with regulatory compliance led to additional strain.

The fast-tracked nature of the CARES Act provisions, combined with limited regulatory guidance, placed organizations at heightened risk of penalties, making clear, consistent regulatory communication essential to mitigating compliance risks.

DDReg’s Capabilities

DDReg Pharma is well-equipped to mitigate the challenges posed by the CARES Act in the context of USFDA regulations. With a team of regulatory experts who stay continuously updated on evolving FDA guidelines, DDReg ensures timely and compliant submissions for clients. Additionally, the company aligns regulatory strategies across multiple regions using international standards, ensuring seamless global submissions and compliance, even in the face of complex OTC drug modernization.