In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.
Two factors enabled the US Food and Drug Administration to continue pressing the pharmaceutical industry on quality with warning letters in 2021 and 2022 even after the COVID-19 pandemic largely grounded its inspectorate, according to agency data analyzed by the Pink Sheet.
One: The agency became more selective with the drug good manufacturing practice inspections it was able to conduct.
Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
