Generics import untested ingredients and produce contaminated or understrength drugs

If a grocery store steeply discounted rotting cuts of meat or produce, would you buy them? Probably not. By the same logic, if a pharmacy tried to sell medications that are understrength or contaminated, few of us would go along. Bad meat you can smell or taste, but you can’t do that for bad meds. Unfortunately, we can’t be sure that our generic drugs are consistently safe and effective, because they aren’t independently tested before they’re sold. We simply assume they are safe. For decades, the U.S. Food and Drug Administration has used paperwork reviews and occasional plant inspections to ensure that companies make safe products. Because the agency believes that quality and safety are the manufacturer’s responsibility, it does not routinely test the medicines themselves. Pharmaceutical companies spend huge sums of money to create new drugs and secure the FDA’s approval for sale, so they can’t afford to slip up. But when a drug’s patent expires and competitors start offering low-cost generic copies, the FDA’s “honor system” can break down. In the cutthroat world of generic drug manufacture, the cheapest producer usually wins—whether they follow the rules or not. Intense global competition pushed most generic drug and ingredient production overseas to countries with low labor costs and weak regulatory controls. Once that happened, reports of contaminated or understrength drugs grew. Rather than recognize and respond to the threat, the FDA kept assuring the public that, “You can take a generic medicine as an equal substitute for its brand-name counterpart.” This statement implies that all generic drugs sold in the U.S. are equally safe and effective. Although most meet minimum quality standards, not all do. Currently, American patients, doctors and hospitals have no way to differentiate high-quality generic drugs and the companies that make them from the manufacturers that cut corners. The FDA’s approach to monitoring can take years to spot a problem. The only way to strengthen the process is to independently evaluate the quality of generic medicines in accredited labs before they are sold. There’s only one problem. The FDA is pushing back on calls for independent testing. Growing Problems Valisure, an independent drug testing laboratory, found dangerous contaminants in two widely sold generic drugs and some OTC products in 2019, according to Consumer Reports. Recalls followed. It found benzene, a carcinogen, in some hand sanitizers, and the FDA responded by subjecting Valisure—as opposed to the manufacturer—to an exhaustive multiweek inspection. The FDA accused the lab of operating without proper regulatory approvals, but documents obtained by Consumer Reports revealed that the agency thought Valisure was testing products to help companies secure FDA approval, work Valisure doesn’t do. Instead, Valisure performs independent quality testing to help purchasers make informed decisions. In 2021, FDA learned from its European counterpart that bioequivalence studies of approximately 100 generic drugs conducted by two Indian contract research organizations were flawed by irregularities. Europe suspended marketing of the products, but the FDA did not. Instead, it allowed the suspect drugs to continue to be sold with a special code to pharmacists that they shouldn’t consider them “automatically substitutable” for their brand-name counterparts. The FDA responded to concerns in an emailed statement: “Protecting patients is the highest priority of the FDA and Americans can be confident in the quality of the products the FDA approves. The FDA continues to work to build a safe, secure and agile drug supply chain so that American patients have the medications they need – medications that have been carefully reviewed by the FDA for safety, effectiveness and quality. Should healthcare systems choose to implement additional testing, it is imperative that such testing use validated methods conducted by validated labs, rather than risking invalid results.” In 2022, the U.S. Government Accountability Office reported that the FDA is struggling to conduct rigorous inspections of overseas plants. For example, domestic manufacturers are subject to “no-notice” inspections, but many foreign inspections are preannounced. Although the agency promised to do better, problems persist. According to Bloomberg, “years can pass between inspections.” While regulatory action is focused on India, China is making it nearly impossible for the FDA to properly inspect its plants. During the pandemic, China’s travel ban forced the FDA to conduct many inspections remotely, via the internet. In July, China enacted an “anti-espionage law” that gives authorities sweeping powers to label business activities they don’t like “espionage.” In October, China arrested a Japanese pharmaceutical executive who has worked in the country for 20 years. Actions like these may weigh on the minds of FDA inspectors in China. To determine if any suppliers of generic medicines to the military health system are selling substandard products, the Pentagon initiated a pilot testing program in 2023. Kaiser Permanente and a handful of academic medical centers are also testing some of their generic drugs. More health systems could follow.