The FDA is currently delaying most international reviews through April, active immediately, due to the global COVID-19 break, one and the company is considering actions against businesses that require to treat or stop the virus.
The FDA based their decision to postpone foreign reviews on several factors, including State Department Level 4 travel reports, which states that travel is banned for United States government representatives, CDC travel directions, entrance restrictions required on foreign visitors by different countries, the leadership from the Office of Personnel Management, and the significance of the health and safety of agency workers.
In the report announced Tuesday, the FDA Commissioner Stephen M. Hahn, MD, told investigations outside the United States that are considered mission-critical will still be held on a case-by-case foundation. His statement also remarked that the FDA is fully poised in its capacity to maintain oversight over worldwide manufacturers and shipped products using alternative tools and techniques.
Valid Precautions
Executives with the FDA are briefly not allowed to inspect foreign-produced FDA-regulated goods or manufacturers really; yet, as an interim step, they will employ extra tools to guarantee the security of the goods imported to the United States.
These mechanisms involve refusing entry of unsafe products into the United States, physical examinations and product sampling at US borders, evaluating a firm’s previous agreement history, using data sharing from foreign states as part of mutual recognition and confidentiality arrangements, and requesting records in advance of or instead of on-site drug reviews.
The agency will proceed to work with US Customs and Border Protection to target products intended for importation into the United States that violate applicable legal requirements for FDA-regulated products. Its risk-based import screening tool, known as PREDICT, will be used to focus their examinations and sample collections based on heightened concerns of specific products entering into US commerce.
“Americans can rest assured the FDA is diligently monitoring this outbreak and the impact on our operations. Our leadership team meets daily to talk about the myriad of urgent issues facing us as we actively facilitate efforts to diagnose, treat, and prevent the disease; survey the medical product supply chain for potential shortages or disruptions, and help to mitigate such impacts, as necessary; and leverage the full breadth of our public health tools, including enforcement tools to stop fraudulent COVID-19 activity,” Hahn said.
According to Hahn, the FDA considers the sale and promotion of fraudulent products to be a threat to public health. “We understand consumers are concerned about the spread of COVID-19 and urge them to talk to their health care providers, as well as follow advice from other federal agencies about how to prevent the spread of this illness,” said Hahn, in a prepared statement.2 “We will continue to aggressively pursue those that place the public health at risk and hold bad actors accountable.”
Monitoring Drug Supply
The FDA and FTC jointly issued warning letters to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC, doing business as N-Energetics, GuruNanda, LLC, Vivify Holistic Clinic, Herbal Amy LLC, and The Jim Bakker Show. The products cited in these warning letters are teas, essential oils, tinctures, and colloidal silver.2
The FDA also has been monitoring the drug supply chain with an expectation that COVID-19 would likely impact pharmaceuticals. The agency recently announced that at least one drug manufacturer had reported a shortage of a human drug due to a manufacturing site affected by COVID-19.3.
The FDA will continue to assess and calibrate their approach as needed to help advance federal response efforts.
