The cross-contamination of pharmaceutical products is a persistent problem the industry does not fully disclose or understand, according to a July 25 Bloomberg report.
The issue, which some experts argue is inevitable, occurs when drugmakers stamp out pills on the same machine that is used to stamp out a different pill.
Drug cross-contamination is rampant, but the amount of cross-contaminated drugs that have been prescribed to Americans remains unclear because drugmakers largely handle the matter themselves, supervisors are often lax on cross-contamination guidelines and employees are fallible, current and former FDA inspectors told Bloomberg.
The FDA determines how often it will inspect drug manufacturing plants based on its calculation of risk associated with each facility, so many plants go years without inspections.
Comprehensive independent testing is difficult to achieve because inspectors would need to know which substances they're looking for, and drugmakers don't disclose which products they make at which factories.
When a routine test reveals an inappropriate substance in a drug, drugmakers often don't test them for cross-contamination. If they say their cleaning policies are rigorous and they haven’t recorded elevated levels of drug substance left behind, they deem cross-contamination testing to be unnecessary, current and former FDA inspectors told Bloomberg.
The inspectors also said the FDA has not routinely collected samples of drugs for cross-contamination testing after red flags are found.