As the COVID-19 pandemic wore on, industry clamored for the US FDA to re-inspect troubled drug manufacturing plants remotely if need be to clear them for new approvals. Now FDA investigators are out in force and early returns from Sun, Aurobindo, Lupin and Sterling suggest these re-inspections will be as tough as ever.
Inspection reports recently posted on the US Food and Drug Administration’s website suggest that pharmaceutical manufacturers are finally getting the follow-up inspections that could clear their manufacturing facilities for new brand and generic drug approvals, but which pandemic travel restrictions had delayed.
But not all the wished-for inspections went as well as might
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
