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WASHINGTON– When you buy eye drops from a US store, you can assume that you are purchasing a product made in a clean, well-maintained factory that has been approved by health regulators.
But repeated recalls of over-the-counter products are drawing attention to how little U.S. officials know about conditions at some manufacturing plants on the other side of the world and the limited tools they have to intervene when there is a problem.
The Food and Drug Administration is asking Congress for new powers, including the ability to order drug recalls and require eye drop makers to undergo inspections before shipping products to the U.S. But experts say that those capabilities will be of little use without more staff and resources for foreign inspections, which were a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits.
“The FDA is not doing its job in terms of quality control inspections of drugs abroad,” said David Ridley of Duke University and co-author of a recent paper analyzing the decline in inspections. “Very few foreign drug manufacturers have been inspected in the last four years.”
In 2022, FDA foreign inspections are down 79% from 2019, according to agency records compiled by Ridley’s group. Inspections increased this year, but are still far below pre-pandemic levels.
FDA spokesman Jeremy Kahn said, “The FDA works to inspect as many facilities as possible, but ultimately the industry is responsible for the quality of its products.”
Two dozen brands of eye drops were recalled in October after FDA staff found cracked floors, barefoot workers and other unsanitary conditions at a Mumbai plant that supplied products to CVS, Walmart and other major retailers. It was the first time FDA staff had visited the site.
That inspection was prompted by an earlier recall of contaminated eye drops from a different Indian plant that has been linked to four deaths and more than a dozen cases of vision loss. That plant had also never been inspected before.
“These are very rare cases, but what we’ve seen is that these products can cause real harm,” said Dr. Timothy Janetos, an ophthalmologist at Northwestern University. “Something needs to change.”
Experts point out three possible changes:
PREVIOUS INSPECTIONS
Prescription drugs are highly regulated. Before a drug maker can sell a drug in the U.S., it must undergo an FDA review to establish its safety and effectiveness. As part of the process, the FDA typically inspects the factory where the drug will be manufactured.
But eye drops and other over-the-counter products do not undergo preliminary reviews or inspections. Instead, they are governed by a different system called a monograph, which is essentially a generic prescription for all drugs in a particular class. As long as drug makers certify that they are using the standard prescription, they can launch a product within days of submitting their application to the FDA.
“It’s nothing more than electronic paperwork,” said Dr. Sandra Brown of the Dry Eye Foundation, a nonprofit that advocates for greater regulation. “It is not necessary to inspect the premises before submitting them for sale.”
The FDA says it has flexibility to adjust its review process “to ensure safety.”
But the agency is asking Congress for the power to require makers of eye drops and other sterile products to give at least six months’ notice before shipping products from a new factory. That would give inspectors time to visit facilities that aren’t on their radar.
The proposal could face pushback from some over-the-counter drug makers, who are not accustomed to pre-approval inspections.
But Brown says the unique risks of contaminated eye drops require a different approach than pills and tablets.
“Anything you eat will encounter stomach acid, which will kill most of the bacteria,” Brown said. “It’s much more dangerous to put a product in your eye.”
REQUIRING MEMORIES
The FDA warned consumers in late October not to use eye drops sold at CVS, Rite-Aid and other stores. But the products were not officially removed from the market until November 15, almost three weeks later.
This is because the Indian manufacturer Kilitch Healthcare initially refused to cooperate. The FDA can force a recall of foodmedical devices and many other products, but lacks the same authority for drugs and must instead ask companies to take action voluntarily.
The FDA recently asked Congress for mandatory authorization to recall drugs.
FINANCING OF FOREIGN INSPECTORS
Since the 1990s, drug manufacturing has increasingly moved to India, Porcelain and other countries with lower costs.
The Government Accountability Office has for years expressed concerns about the FDA’s oversight of the global supply chain, flagging it as a “high risk” issue for more than a decade.
The FDA said in a statement that it uses “all available tools” to ensure that Americans get “high-quality, safe and effective” medicines.
The agency generally gives priority to factories that have never been inspected or have not been inspected in the last five years. It stopped most routine in-person foreign inspections in March 2020 and did not resume them until 2022. The agency did not conduct any inspections in India during the first year of COVID-19.
FDA leaders have long said it is a challenge to recruit and retain foreign inspectors.
Experts say Congress can and should address that.
“Federal hiring is inherently slow and salaries are often not competitive,” said Ridley, the Duke researcher. “Congress should try to help the FDA solve that problem and then hold it accountable for personnel inspections.”
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
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