Keeping tabs on Covid-19: GAO addresses concerns over FDA backlog and pharma discovers crucial jigsaw piece to help fight coronavirus
Discover how the FDA plans to address its growing backlog of foreign manufacturing inspections amid the Covid-19 pandemicAdd bookmark
There are no signs of the pharma industry withdrawing from the limelight as pressures continue to mount in the battle to contain the spread of Covid-19.
This week, Pharma IQ covers the announcement made by the US Government Accountability Office (GEO) over growing concerns on the handling of global drug safety and manufacture by the US Food and Drug Administration (FDA). Meanwhile, in the UK, a diagnosis company has developed a T cell test to determine how adaptive people have become to Covid-19 following vaccination.
GAO presses FDA to address issues presented by Covid-19 backlog
The GEO has pressing concerns about the FDA’s ability to oversee the increasingly global pharmaceutical supply chain after the Covid-19 pandemic amplified supply chain issues that had already been mounting long before last March.
The GEO highlighted that the FDA has paused most international inspections since March 2020 to safeguard its employees, used alternative inspection tools to oversee drug manufacturing quality, such as relying on foreign regulators and sampling and testing drug, and faces a backlog of inspections in future years. In fact, “the FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections”, a representative from the GEO commented.
The outbreak of coronavirus called for greater attention to drug manufacturers. The GAO conducted a study in December 2019 that indicated the FDA's practice of preannouncing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection, which raised questions about their equivalence to domestic inspections.
This led to the GEO releasing a statement that recommended: “In 2021, the FDA needs to ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that the FDA will fully assess the agency's alternative inspection tools. The FDA has concurred with both our recommendations.”
In addition, “the FDA has begun to assess how its alternative tools can be used to supplement its regular inspection activities or substitute for them when inspections are not possible, but there needs to be a complete assessment in place”, Mary Denigan-Macauley, Director of GAO's healthcare team reported to FiercePharma. To complete assessments to the best of their ability during the Covid-19 pandemic the regulatory agency should look into if “additional tools, such as remote video interactions, could be useful”, Denigan-Macauley added.
UK diagnostic firm offers governments a solution to allow for freer movement locally and aboard
The UK diagnostics company Oxford Immunotec has developed a Covid-19 test called T-SPOT.COVID that identifies individuals who have gained an adaptive immune response (specifically a T cell response) to SARS-CoV-2 after being vaccinated against the virus. The company has filed an Emergency Use Authorization request to the FDA in the US for the test.
T cells are becoming increasingly recognized for their role in detecting the SARS-CoV-2 infection and immunity rates.
Phill Keefe, Senior VP, Product Design, Development and Delivery at Oxford Immunotec, explained: “T cells and antibodies are two arms of the adaptive immune response. The detection and measurement of each can provide different insights about disease activity and an individual’s personal immunity.”
The company’s T-SPOT.COVID test has been based on the technology widely used in the medical field to diagnose tuberculosis (TB) where it is approved for use by medical licensing agencies in the US, EU, China and Japan. When the technology is in combination with serology testing, Oxford Immunotec claimed T cell testing could help governments and medical agencies plan for future restrictions by having a better understanding of population-wide immunity, especially after vaccination, roll out more comprehensive testing programs and allow for freer movement in the community or internationally.
Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec, said, “The T-SPOT technology platform is a standardized way of measuring T cells. It has been proven in clinical use for more than 18 years with another major infectious disease, TB, which kills around 1.5 million people every year.
“Our T-SPOT.COVID test is tailored specifically for the detection and measurement of an individual’s T cell response to SARS-CoV-2 infection. Having the ability to determine an individual’s immune response to SARS-CoV-2 has the potential to support a wide range of needs in our battle against the Covid-19 pandemic,” Wrighton-Smith added.
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