Apparently, when a grocery store goes on to steeply discount rotting cuts of meat or produce, would one buy them? May be not. If we go by the same logic, if a pharmacy went ahead and sold medications that had a dearth of availability or were contaminated, there would be a few who would go ahead. Notably, bad meat you can smell or taste, but when it comes to bad meds, one really cannot tell. The same way, one cannot really be sure if the generic drugs are consistently safe and effective, as they don’t happen to be independently tested before they get sold. It is simply assumed that they are safe.
It is for decades that the U.S. Food and Drug Administration has made use of paperwork reviews and occasional plant inspections so as to ensure that companies make safe products. Due to the fact that the agency believes that quality as well as safety are the manufacturer’s responsibility and that it does not routinely test the meds themselves.
Pharma companies go on to spend huge amounts of money in order to create new drugs as well as secure the FDA’s approval when it comes to sale; hence, they really cannot afford to slip up, but when a patent pertaining to a drug expires and competitors begin offering low-cost generic copies, the honor system by the FDA can break down. In this cutthroat world of generic drug production, the cheapest producer mostly wins, whether or not they follow the rules.
The fact is that intense global competition has pushed most generic drug as well as ingredient production beyond the borders to countries that have low labor costs along with weak regulatory controls. As that took place, reports of drugs that were contaminated or lacking in strength surged. Rather than recognize as well as respond to the threat, the FDA made sure of assuring the public that one can go ahead and buy a generic medicine as an equal substitute for its brand-name counterpart. This statement goes on to imply that all generic drugs that are sold in the U.S. happen to be equally safe along with being effective.
Though most drugs go on to meet minimum quality standards, but not all do. At present, American patients, doctors, as well as hospitals have no way to distinguish high-quality generic drugs and companies that happen to make them from the manufacturers that go ahead and cut corners. The FDA’s approach to this tracking can take years to recognize a problem. Apparently, the only way to strengthen the process is by independently evaluating the quality of generic medicines in accredited laboratories before they are brought to the market.
However, there’s only one problem, and that’s that the FDA is pushing back on calls when it comes to independent testing.
Mounting Problems
Valisure, which happens to be an independent drug testing lab, went on to find dangerous contaminants in two majorly sold generic drugs as well as some OTC products in 2019, as per Consumer Reports. Thereafter, recalls took place, and it was found that benzene, a carcinogen, was in some hand sanitizers. Hence, the FDA responded by subjecting Valisure and not the manufacturer to an exhaustive multiweek inspection. The FDA went on to accuse the lab of operating sans proper regulatory approval; however, the documents obtained by Consumer Reports went on to reveal that the agency thought Valisure was getting the products tested to help companies get FDA approval, a work that Valisure does not do. Rather, Valisure goes on to perform independent quality testing in order to help purchasers make informed decisions.
It is well to be noted that in 2021, the FDA happened to learn from its European counterpart that bioequivalence studies of almost 100 generic drugs that went on to be conducted by two Indian contract research organizations were flawed due to irregularities. Thereafter, Europe suspended marketing of the products; however, the FDA did not. Rather, it allowed the suspect drugs to continue to get sold with a special code to pharmacists that they would rather not consider them as automatically substitutable for their brand-name counterparts.
The FDA responded to the concerns in an emailed statement, stating that protecting patients happens to be their highest priority and Americans can be confident when it comes to the quality of products the FDA gives nod to. The FDA works to build a safe, secure, as well as an agile drug supply chain so that American patients get the medications, they require the ones that are carefully reviewed by the FDA when it comes to safety, effectiveness, as well as quality. Should healthcare systems opt to execute more testing, it is mandatory that such testing make use of actual methods conducted by validated labs instead of risking results that are invalid.
In 2022, the U.S. Government Accountability Office went on to report that the FDA happens to be struggling to do rigorous checks on overseas plants. For instance, domestic manufacturers are subject to no-notice inspections; however, many foreign inspections get preannounced. Though the agency promised to make this better, problems still persist. Bloomberg says years can pass between inspections.
Although regulatory action is focused on India, China, on the other hand, is making it almost impossible for the FDA to check its plants properly. All through the pandemic, China’s travel ban compelled the FDA to get many inspections done remotely through the internet. In July 2023, China came up with an anti-espionage law that goes on to give authorities sweeping powers to label business activities they don’t like as espionage. In October 2023, China went ahead and arrested a Japanese pharmaceutical executive who had worked in the country for 20 years. Actions such as these may have an effect on the minds of FDA inspectors across China.
In order to gauge if any suppliers when it comes to generic medicines to the military health system happen to be selling substandard products, the Pentagon went on to initiate a pilot testing program last year. Kaiser Permanente, as well as a handful of academic medical centers, are going ahead and testing some of their generic drugs. More health systems are expected to follow.
Congress looks Concerned
Numerous House as well as Senate committees on Capitol Hill are asking the FDA to do more. On December 13, Kathy McMorris Rodgers (R-WA), House Energy and Commerce Committee Chair, as well as two subcommittee chairs, wrote quite a strict letter to Dr. Robert Califf, the FDA Administrator, with regards to the problematic oversight when it comes to foreign drug production facilities. They went on to threaten to issue a subpoena if the agency did not go ahead and answer a lengthy set of questions by January 5.
The same day when the FDA’s response was due, the agency went on to announce that it would enable Florida to import drugs from Canada. The state must make sure that the imported drugs happen to be potent and not counterfeit, as per the New York Times, and the only way this can be achieved is by testing products, something the FDA does not at present require of generic drugs or any ingredients imported from India, China, or even other countries.
A Way That’s Much Better
Rather than viewing these developments as issues, the FDA can look at them as opportunities.
For instance, the European Union’s counterpart to the FDA, which is the European Medicines Agency, operates along with a network of official medicine control laboratories that function in sync with ISO/IEC 17025 benchmarks. An OMCL brochure goes on to explain their purpose and states that throughout their entire life cycle, medicines may be selected by authorities pertaining to independent quality control, which involves laboratory testing as well as other monitoring measures. Not having these independent controls would mean that patients, as well as users of medicines in Europe, could be exposed more often to defective, falsified, and illegal products.
It is well to be noted that a private-sector analog of this model can go on to work in the U.S. Worrisome findings, once verified, can be reported to the FDA for a probable investigation. Test results along with past regulatory actions can be combined so as to create either a red, yellow, or green quality score system that goes on to rank manufacturers on the basis of their performance. As most generic drug shortages happen to be due to quality-related challenges, sourcing from reliable manufacturers may as well decrease such challenges.
