If there’s one thing 2020 taught the world, it’s that the road ahead is ever-changing. Given the Delta variant on the rise and the significant backlog of FDA inspections, it is unclear when and how the agency will resume a regular inspection protocol. Devon Copley at Avatour discusses this, however, is certain, the government wants to move the needle along and make tangible progress in addressing the backlog. With the government boosting unannounced inspections and considering bringing remote technology into the regular inspection protocol, it is clear times are changing. Companies’ best chance at adapting to the new reality is to be prepared and open to alternative technologies.
Extract:
‘Preparing for FDA Remote Inspections: What to Expect for 2022’
With no clear protocol for resuming inspections amid ever-changing pandemic guidelines, the FDA slowly began to roll out limited high-priority domestic inspections in Summer 2020. Over a year later, the FDA is still prioritising mission-critical work, with no transparent plan on what the future will hold. Clearly, the organisation faces a staggering backlog. FDA inspections decreased by 56% in fiscal 2020 compared to previous years. While the FDA did not halt altogether, only three international and fifty-two domestic examinations were considered “mission critical” between March 2020 to October 2020.
As the world begins cautiously opening up, the FDA has a big problem to solve. Approximately 23,297 total inspections remain through 2021, 857 of which are for drugs and pharmaceutical companies. Understandably, the FDA faces significant pressure from the government on how and when the agency will address the backlog. Although a bipartisan group of lawmakers from the House Energy and Commerce Committee released a statement acknowledging that COVID-19 will likely impede in-person inspections throughout 2021, the government is still trying to get ahead of the issue in the form of legislation.
Last month, the House Appropriations Committee released its budget for the fiscal year 2022, which provides a $257 million increase in funding for the FDA. The funds will be used over several categories, notably increased inspections (foreign unannounced and high-risk), data modernisation, and drug safety surveillance and oversight.
Click the download button below to read the complete version of ‘Preparing for FDA Remote Inspections: What to Expect for 2022′ by Devon Copley at Avatour
