When Americans purchase generic drugs, they are seldom aware that the product in their hands may have been manufactured in the outskirts of Mumbai, or in some obscure Chinese province.
Recently, a foreign-made drug was found to contain traces of carcinogenic substances. As the House Energy and Commerce Committee discusses how to maintain the safety of the global drug supply, the pharmaceutical industry lobby fights to prevent the implementation of more stringent regulations.
These lobbyists would have us believe that offshore manufacturing plants adhere to the same rules as U.S.-based facilities. Meanwhile, the FDA tries hard to persuade consumers that its oversight of foreign-based manufacturers is adequate and efficient.
Recently, STAT, a Boston Globe Media company, analyzed FDA inspection records from 2014 to 2019. The probe focused on inspections that took place in China, India, Europe, and the U.S. What it found was far from the FDA’s optimistic views.
According to the CEO of the data analytics company in charge of the investigation, “Egregious data integrity violations are alive and well, especially in China and India. While the U.S. and Europe are not immune to serious data integrity violations, China and India are at least twice as likely to have these issues.”
While only 15 percent of plant inspections in the U.S. found data integrity rule violations, the figure was 44 percent in India and an equally alarming 48 percent in China. These types of violations occur when manufacturers fail to provide unaltered records about each step in the manufacturing process.
||Inspections that found violations
||Data integrity violations
||Data manipulation violations
Data from STAT-FDAzilla
The analysts’ findings may be shocking, but they don’t accurately reflect how business is conducted at overseas drug manufacturing plants. In fact, there is a fundamental flaw to the FDA’s inspection process; outside the U.S., FDA inspectors do not show up unannounced.
This means that plant managers have time to get rid of compromising records and to put up a show of ‘compliance’ to satisfy regulators.
For a short period of time, the FDA gave India-based plants very short notice when an inspection was imminent. This led to a 60 percent increase in serious violation reports.
As the House of Representatives considers whether pre-announced FDA inspections are problematic, STAT found that lab technicians in China and India routinely delete irregular test results in order to mask manufacturing problems. When comparing violations in the U.S. and in Asian countries, the violations tend to be more egregious overseas.
By scanning thousands of FDA inspection documents for terms like ‘backdating’, ‘deletion’, and ‘falsification’, the analysts found that while only 28 percent of problematic U.S. plants engaged in “truly deceptive” behavior, the number in India was 55 percent, and 65 percent in China.
STAT found many cases of egregious misconduct, several of them being quite recent. Last January, the FDA found that Goa-based Indoco Remedies faked test data to get a diabetes drug to market, when in fact, it did not meet the agency’s quality standards. This is a perfect example of manufacturers putting patients at risk to boost profits.
Generics manufactured in unsafe conditions may contain impurities that can seriously harm patients. In another case, Americans who underwent a heart transplant in Cleveland rejected the organ because the Indian-made anti-rejection drugs they received were not effective.
Drug manufacturing plants must implement microbial testing of surfaces, air, and water. Falsifying records for tests that were not performed can put consumers at serious risk. Generic drugs help ensure affordability in the context of skyrocketing drug prices, but if they are not safe, the original purpose is defeated.
Relying on pre-announced inspections is not enough to protect U.S. consumers. Doctors have been known to prescribe generics even when they are aware of specific issues uncovered at the plants that manufacture them.
In Boston, a doctor prescribed a generic drug to a girl who had received a bone marrow transplant. When her mother raised concerns about impurities and ineffectiveness (violations by the drug’s manufacturer had been in the press), the physician “said he knew of the problems but not to worry.”
Only by making unannounced inspections and demanding full compliance from foreign-based manufacturers will the FDA fulfill its mission. The system appears to be designed to allow low-quality drugs to flood the U.S. market, and if we want consumers to be safe, that system needs to change.
If you suspect your pharmaceutical employer or other company is participating in similar illegal drug marketing tactics or other pharmaceutical fraud, contact us confidentially by emailing us at [hidden email] or call us at 202.780.9957.
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