In releasing its annual report card for drug manufacturing inspections in which the per-country/region grading curve peaked at 77% and bottomed at 68%, the FDA said, “All of these scores indicate an acceptable level of compliance to CGMPs [current good manufacturing practices] on average.”
That statement took me back to a conversation I overheard a number of years ago in Namibia. A few mothers were complaining about the 80% score required to pass an international test their teenagers were studying for. They thought the threshold for passing was too high. Then another mother put it in perspective. “If you were flying in a plane through a storm, would you want a pilot who had passed the flight test with only an 80% score?” she asked. “I’d be concerned about one who had gotten only 90% of the test right.”
When lives are on the line, the quality of the drugs we take matters. Is a 68% drug inspection score, or even a 77%, really acceptable for a patient who may be fighting cancer or struggling with an immune issue?
The FDA explains the low, but “acceptable,” marks by pointing out that the averages include inspection scores for facilities that manufacture homeopathic products and sterile over-the-counter (OTC) drugs, as well as prescription drugs and biologics. The 6.2 score for OTC drugs and 6.5 for homeopathics “pull down” the averages, the agency said.
Again, that begs the question of why sites with such poor cGMP compliance are allowed to produce even OTC drugs for the U.S. market. Patients who have to take OTC drugs to help control the side effects of chemo shouldn’t have to worry about the quality of those drugs while they’re dealing with all the other challenges of cancer.
The allowance of carcinogens, glass particles, insect pieces, rodent droppings, cross-contamination, mislabeling, excessive or inadequate amounts of active ingredients, improper storage, residual solvent and fraudulent data endangers lives – whether a drug is OTC or prescription.