Experts say safer eye drops will require new FDA powers after recalls, infections

WASHINGTON (AP) When you buy eye drops in a U.S. store, you might think you’re buying a product made in a clean, well-maintained factory that has passed the scrutiny of health regulators.

But repeated recalls involving over-the-counter drugs have raised new concerns about how little U.S. officials know about conditions at some manufacturing plants on the other side of the world and how limited the tools they have to intervene when problems arise.

The Food and Drug Administration is asking Congress for new powers, including the ability to force drug recalls and require eye drop manufacturers to undergo inspections before shipping their products to the United States, but experts say without more staff and resources it will Foreign inspections, these capabilities will have no effect. This was a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits.

read more: FDA says eye drops from CVS, Rite Aid and others may pose infection risk

David Ridley of Duke University, a co-author of a recent paper tracking the inspection slump, said the FDA is not doing its job when it comes to quality assurance inspections of foreign drugs. Few foreign drugmakers have been inspected over the past four years.

According to agency records collected by Ridley’s team, the number of FDA foreign inspections decreased by 79% in 2022 compared with 2019. Inspections have increased this year but are still well below pre-pandemic levels.

FDA spokesman Jeremy Kahn said: The FDA is committed to inspecting as many facilities as possible, but ultimately industry is responsible for the quality of its products.

In October, FDA staff recalled two dozen eye drop brands after finding cracked floors, barefoot workers and other unsanitary conditions at a Mumbai factory that supplies products to CVS, Walmart and other major retailers. This is the first time FDA staff have visited the site.

The inspection was prompted by an earlier recall of tainted eye drops made at another factory in India that had caused four deaths and more than a dozen cases of vision loss. The plant had also never been inspected before.

Dr. Timothy Janetos, an ophthalmologist at Northwestern University, said these cases are very rare, but we are seeing that these products can cause real harm. Something needs to change.

Experts point to three possible changes:

early inspection

Prescription drugs are strictly regulated. Before drug manufacturers can market a drug in the United States, it must be reviewed by the FDA to determine its safety and effectiveness. As part of this process, the FDA typically inspects the factories where the drugs are manufactured.

But eye drops and other over-the-counter products do not undergo preliminary review or inspection. Instead, they are governed by different systems called monographs, which are essentially universal formulas for all drugs in a specific class. As long as drugmakers prove they are using a standard formulation, they can launch the product within days of submitting paperwork 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. There is no requirement to inspect the facility prior to shipping for sale.

The FDA said it has the flexibility to adjust its review process to ensure safety. “

But the agency is asking Congress for authority to require manufacturers of eye drops and other sterile products to provide at least six months’ notice before shipping from new plants. This will give inspectors time to visit facilities that are not on their radar.

The proposal is likely to face resistance from some over-the-counter drug manufacturers who are not used to pre-approval inspections.

But Brown said the unique risks of contaminated eye drops require a different approach than pills and tablets.

Anything you swallow meets your stomach acid, which kills most bacteria,” Brown said. Putting the product in the eyes is even more dangerous.

Request a recall

The FDA warned consumers in late October not to use eye drops sold at CVS, Rite-Aid and other stores. But it wasn’t until November 15, nearly three weeks later, that the products were officially recalled.

This was because Indian manufacturer Kilitch Healthcare initially refused to cooperate. The FDA can force recalls of food, medical devices and many other products, but it lacks the same power over drugs and must require companies to take action voluntarily.

The FDA recently asked Congress to impose a mandatory recall of the drug.

Funding foreign inspectors

Since the 1990s, drug production has increasingly moved to India, China and other lower-cost countries.

The Government Accountability Office has expressed concerns for years about the FDA’s oversight of global supply chains, labeling it a high-risk issue for more than a decade.

The FDA said in a statement that it uses all tools at its disposal to ensure Americans have access to high-quality, safe and effective medicines.

The agency generally prioritizes plants that have never been inspected or have not been inspected within the past five years. It stopped most routine, on-site foreign inspections in March 2020 and did not resume them until 2022. In the first year of COVID-19, the agency did not conduct any inspections in India.

FDA leaders have long said recruiting and retaining overseas inspectors is challenging.

Experts say Congress can and should address the issue.

Ridley, the Duke University researcher, said federal recruiting is already slow and salaries are often uncompetitive. Congress needs to try to help the FDA solve this problem and then put them in charge of staffing inspections.

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