Altaf Lal devised the successful—but ultimately discontinued—FDA India pilot plan that put teeth into the formerly toothless inspections.To clean up this swamp, Lal alighted on a long-overdue solution, which he pitched to officials at FDA headquarters: eliminate the months-long advance notice and company-arranged travel plans and give only short notice—or no notice—of investigators' arrival for all inspections in India.
In the early hours, two FDA investigators arrived at the quiet plant and proceeded swiftly to the quality control laboratory. In the lab, they were stunned to see a hive of activity. They found dozens of workers hunched over documents in preparation for the investigators' anticipated arrival the following day. On one desk, the investigators found a notebook listing all the documents the workers needed to forge in anticipation of their arrival.
But in India, the FDA's new inspection program exposed widespread malfeasance that had previously been hidden. By showing up unannounced, the investigators uncovered an entire machinery that had existed for years: one dedicated not to producing perfect drugs, but to producing perfect results. With advance notice and low-cost labor, the plants could make"You give them a weekend, they'll put up a building," as one FDA investigator put it.
juliabhaber This is an extremely upsetting article.
KatherineEban Important exposé. I suffered from a foreign generic before a doc caught the problem. An acquaintance relied on foreign insulin - I believe it caused his untimely death. We, generally speaking, put too much trust in our federal agencies. Of course, that is changing.