Monday, May 13, 2019

You'll never look at a pill bottle the same way again

The New York Times has an interesting snippet from an upcoming book about the generic drug industry by Katherine Eban: 
A new head of the F.D.A.’s India office, Altaf Lal, arrived in mid-2013. To tame the twin problems of company fraud and compromised investigators, Mr. Lal made a novel pitch to agency officials. He proposed a pilot program to make all inspections in India either on short notice or unannounced. By December 2013, he had a green light. The results were instantaneous. 
In January 2014, the F.D.A. was planning an unannounced inspection at a plant in northern India on a Monday. Fearing that plant officials had heard they were coming, Mr. Baker and his colleague went a day early, unannounced. They proceeded to the quality control laboratory, expecting it to be quiet on Sunday morning. Instead, they were stunned to see a hive of activity. Dozens of workers hunched over documents, backdating them. On one desk, Mr. Baker found a notebook listing the documents the workers needed to fabricate in anticipation of the inspectors’ arrival. There were Post-it notes stuck to some surfaces, noting what data to change. 
In large swaths of India’s generic drug industry, the pilot program uncovered a long-running machinery dedicated not to producing perfect drugs but to producing perfect data. At one plant, Mr. Baker went straight to the microbiology laboratory and found the paperwork for testing the sterility of the plant in perfect order: microbial limits testing, biological indicators, all the samples with perfect results. Yet most of the samples didn’t exist. The plant was testing almost nothing. The laboratory was a fake.
It's a good thing that pilot program is continuing. What's that you say? The FDA canceled it? Oh, well. 

1 comment:

  1. I would not take a generic delayed release drug form made in India or Israel (yes, Teva has had lots of problems). Too often the formulation is not done well and the drug release profile is not what it is supposed to be. They need to do bioequivalenecy study of their formulation at the beginning, but later the batches are only assayed for API content