Manipulating data, destroying documents, altering staff training records, retesting samples and only recording those that pass – drug companies have been caught doing all these things.
The only thing stopping them: the element of surprise in the hands of strong regulators. The regulators may still be vigilant, but the pandemic put the brakes on unannounced inspections. Restoring them could save lives.
When prescription drug manufacturing largely migrated to China and India in the 1990s and early 2020s, major regulatory agencies were unprepared for the shift. Instead of inspections, they mostly relied on the manufacturers’ honour system.
