Like most other products here in the U.S, very few drug companies continue to manufacture their products here in this country. Instead, nearly 90% of prescription and nonprescription drugs alike are manufactured abroad in countries like India and China.
The dangers associated with manufacturing medications or drugs abroad are significant. The most pressing of those concerns is that the quality assurance levels in these other countries may be lower than the standards set in U.S. production facilities. This approach puts patients who take prescription or over-the-counter drugs at risk for suffering adverse medical outcomes.
What are the challenges associated with manufacturing drugs abroad?
The U.S. Food and Drug Administration’s (FDA) regulations are a bit stringent. The costs associated with adhering to them can be high.
While it’s easy for FDA inspectors to show up unannounced to domestic pharmaceutical manufacturing plants, it’s much harder for them to do so at overseas factories. Foreign plants often receive notice of visits from inspectors weeks or months ahead, time which often provides an opportunity to bring their plant into compliance.
Many problems happen that inspectors aren’t aware of due to their need to announce when they’re visiting foreign plants. The use of contaminated water in the manufacturing process, for example, is one such concern inspectors often miss. Manufacturers often present inspectors with pretested samples instead of contaminated ones from the bulk supply.
Plants may also alter data, forge test results or claim that there’s been a software corruption issue when regulators request their records. It may also be easier for manufacturers to hide that they use more than one lab (one of which regulators don’t know about) by housing their plants abroad.
What if you suffered an adverse health outcome due to defective drugs?
Many manufacturers usurp FDA guidelines to save time and money. They hope that no one will catch them. Repeat reports from consumers about the same medication may allow regulators to hone in on drug manufacturers’ impropriety, though. An attorney can advise you of your right to hold a drugmaker liable for their actions if you suffered an adverse health outcome.