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 you 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 that they are safe.
The FDA’s Approach to Assuring Generic Drug Quality is Inadequate
For decades, FDA 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 of them 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 our generic medicines in accredited labs before they are sold.
There’s only one problem. The FDA hates the idea.
Growing Problems
According to Consumer Reports, in 2019 Valisure, an independent drug testing laboratory, found dangerous contaminants in two widely-sold generic drugs and some OTC products. Recalls followed. Shortly after it found benzene, a carcinogen, in samples of hand sanitizer, the FDA responded…by subjecting the lab to an exhaustive multiweek inspection. Although the inspectors found nothing of significance, the FDA accused the lab of violating regulations pertaining to the manufacture of drugs, which Valisure doesn’t do. Documents obtained by Consumer Reports did not support the FDA’s assertions.
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.
In 2022, the GAO 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 have a chilling effect on FDA inspectors.
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.
Congress Is Concerned
Multiple House and Senate Committees on Capitol Hill are pressing the FDA to do more. On December 13, the House Energy and Commerce Committee Chair Kathy McMorris Rodgers (R-WA), and two subcommittee chairs wrote a stern letter to FDA Administrator Dr. Robert Califf regarding problematic oversight of foreign drug production facilities. They threatened to issue a subpoena if the agency did not answer a lengthy set of questions by January 5.
The same day the FDA’s response was due, the agency announced that it would allow Florida to import drugs from Canada. According to the New York Times, the state must ensure that the imported drugs are “potent and not counterfeit.” The only way that can be done is by testing products, something the FDA does not currently require of generic drugs or ingredients made in India, China or other countries.
A Better Way
Rather than sticking to its guns, the FDA should rethink its approach.
The European Medicines Agency, the EU’s counterpart to the FDA, works with a network of “Official Medicine Control Laboratories” that operate in accordance with ISO/IEC 17025 standards. An OMCL brochure explains their purpose: “Throughout their entire life cycle, medicines can be selected by the authorities for independent quality control involving laboratory testing and other monitoring measures. Without these independent controls, patients and users of medicines in Europe could be exposed more often to defective (e.g. contaminated) or falsified and illegal products.”
A private sector analog of this model could work in the U.S. Worrisome findings, once verified, would be reported to the FDA for potential investigation. Test results and past regulatory actions could be combined to create a “Red / Yellow / Green” quality score system that ranks manufacturers based on their performance. Because most shortages of generic drugs are due to quality-related concerns, sourcing from reliable manufacturers should reduce this problem.
If we start testing our medicines the way we test other consumer products, everyone will win – including the FDA.
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