A spate of deaths involving eye drops infected with foreign products has sounded alarms about a delay in FDA inspections.
This story was originally published through ProPublica.
For years, U. S. pharmaceutical corporations have beenThey have relied on foreign-produced drugs to satisfy Americans’ medical wishes. And for years, it was clear that federal drug regulators couldn’t keep up with inspections of the factories that made those drugs.
But a spate of recent deaths linked to eye drops infected with bacteria produced overseas shows just how serious the Food and Drug Administration is. Three other people died and 8 others went blind in the United States due to the droplets, which were manufactured in a factory. in the Indian state of Tamil Nadu that the company had never inspected before the outbreak. Even worse, public fitness officials say they have detected the drug-resistant bacterial strain, which had never been noticed in the U. S. In the U. S. , in patients who have never used eye drops, meaning it will most likely spread in the community.
A ProPublica investigation of FDA inspection data in April shows that firm inspections of foreign drugmakers, most often located in India and China, fell precipitously even as the number of brands remained relatively stable. In fiscal year 2019, the year before the COVID-19 pandemic limited andArray the FDA inspected 37% of the approximately 2,500 foreign brands; In 2022, the company inspected only 6% of approximately 2800. And in India, where infected eye drops come from, the FDA inspected only 3% of brands in 2022, particularly less than in 2019, when 45% of factories were inspected.
The FDA, which is guilty of ensuring the protection and effectiveness of prescription and over-the-counter drugs, has identified that limited resources make it inspect each and every factory, in the U. S. and Canada. Whether they are in the U. S. or not, they manufacture drugs or their ingredients. The company has been slow to make improvements.
This is not the first time U. S. consumers have been injured or killed as a result of infected drugs produced abroad. People had allergic reactions, some fatal, to a used blood thinner, triggering an FDA investigation. Some of the cases later related to a component produced in a factory in China that had never been inspected by the FDA.
The Government Accountability Office, a federal watchdog agency, has warned for decades that the number of foreign inspections is worrisome. Just weeks before the first COVID-19 patient organization in China was reported in late 2019, the GAO reported that despite some innovations in how the FDA tracked and prioritized its efforts, inspections of foreign and domestic drug factories were declining, largely due to difficulties in retaining staff and filling vacancies.
“While our source of medication is safe, disorders are emerging, as evidenced by infected eye drops in recent months,” said Mary Denigan-Macauley, director of public fitness at the GAO. “No one needs to lose their sight or an eye just by taking drops to relieve dry eyes. “
To be sure, the COVID-19 pandemic has slowed inspections to a minimum: In fiscal year 2021, according to the data, the company inspected only 99 overseas sites, less than 4% of eligible foreign brands. In comparison, 15% of domestic brands were inspected that year. (Nearly three-quarters of U. S. pharmaceutical brands. More than a portion of the finished drug brands are overseas. )
During the pandemic, the FDA began pronouncing national visits in advance and suspended surveillance visits, unless they were considered “mission critical,” achieving maximum pre-approval of new drugs without visiting overseas production sites.
The FDA defended the ruling in an email to ProPublica, saying it uses “alternative inspection equipment, such as interactive remote assessments, logging applications, and leveraging data from trusted regulatory partners. “
The GAO and Rep. Sanford J. Bishop, a Georgia Democrat, say those remote interactions don’t offer the same information as in-person, unannounced inspections. The FDA itself affirmed the usefulness of inspections in its latest annual pharmaceutical quality report: “In the absence of inspections, many of those situations” that may result in defective products “and imaginable public harm, may have gone unnoticed. “
But 3 years into the pandemic, the FDA has been slow to return to pre-pandemic inspection rates. The pandemic has increased the urgency around the FDA’s drug inspection procedure due to the need for more equipment, vaccines and antiviral drugs, many of which are produced overseas, has more. Although the regime’s internal surveillance inspections resumed in July 2021, foreign inspections of the regime remained suspended until February 2022.
In December, President Joe Biden signed a year-end spending program that allocated $10 million to a pilot program to “increase unannounced foreign inspections” of drugmakers. follow-up programs.
“We will have to protect the health, safety and well-being of the American people,” said Bishop, who has lobbied to fund foreign inspections in the House. “That’s the FDA’s job. “
Experts hope the pilot program will meet criteria surrounding such visits, which have been criticized for being too permissive. Unlike domestic inspections, foreign brands were notified prior to an inspection and allowed to provide their own translators, practices that FDA inspectors say the accumulated information is unreliable. The FDA said it plans to use the additional $10 million to develop overseas inspection personnel and work on prioritizing inspections that the company has been unable to perform during the pandemic.
Among the foreign services inspected was a Global Pharma Healthcare plant in Tamil Nadu that produced synthetic tears sold through U. S. corporations EzriCare and Delsam Pharma. blind spot. While the FDA has the authority to inspect over-the-counter product brands before they are sold to consumers, there is no requirement that a pre-sale inspection be conducted, unlike prescription drugs.
The FDA is asking Congress to require brands to notify the FDA of their goal of distributing over-the-counter drugs well before promoting them, which could give the FDA a “feasible opportunity” to conduct inspections.
But even this requirement hasn’t made much difference. According to the GAO’s 2022 FDA Foreign Inspections Report, a growing backlog of brands in need of regime surveillance inspections is heading in a troubling direction. The percentage of foreign trademarks that had not been inspected in five years, or had never been inspected once, rose from 30% in 2020 to more than 80% in 2022. And if the FDA prioritizes sites that haven’t been recently inspected, it may be at the expense of vetting sites known through the FDA as the greatest threat to public health.
Preventing long-term public health risks, such as the ongoing outbreak of eye drops, will have to be a priority, the GAO’s Denigan-Macauley said.
“These disorders are hypothetical. They’re real,” he said.
In the case of imported infected eye drops, in January, the FDA and the Centers for Disease Control and Prevention traced the Pseudomonas aeruginosa outbreak to EzriCare synthetic tears produced through Global Pharma Healthcare. That same month, the FDA requested manufacturer records related to an unrelated factor and, involved in Global Pharma’s “inadequate response,” placed it on import alert, preventing its products, along with eye drops, from entering the United States. In early February, the FDA recommended recalling EzriCare and Delsam Pharma eye drops. After all, he waited weeks to conduct an on-site inspection, only to find multiple suitability and protection factors. The companies did not respond to a request for comment, though in a February news release, EzriCare said it was cooperating with the CDC and FDA. Global Pharma told The New York Times that it was “cooperating fully with U. S. federal authorities. “UU”.
Irena Hwang is a reporter specializing in ProPublica. She previously worked at National Public Radio, The Associated Press and Dallas Morning News. He holds a master’s degree in journalism and a doctorate in electrical engineering from Stanford University, and studied electrical engineering at the Massachusetts Institute of Technology. Founded in Atlanta, Georgia.
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