The House Energy and Commerce Committee Republican leadership is asking the US Food and Drug Administration for a wealth of information about its approach to inspections in India and China coming out of the COVID-19 shutdown period.
A July 18 letter to Commissioner Robert Califf focuses squarely on a key vulnerability for the agency: how to assure public confidence in drug quality after the long physical site inspection hiatus in two of the largest suppliers for the US. Concerns about the vigor of the FDA’s foreign inspection program predate the pandemic and GOP leadership in the House has redoubled its focus on the topic as a key part of FDA oversight now that pandemic restrictions are receding