Why are so many eye drops being recalled?

(NEW YORK) — There have been dozens of eye drops pulled off shelves in the past year due to bacterial and fungal contamination, with multiple warnings issued by the Food and Drug Administration.

Experts and advocates say one reason is likely that in-person faculty inspections slowed significantly during the pandemic, meaning there’s been less regulatory oversight. Now, however, federal regulators may be cracking down after some consumers reported serious health effects.

The latest warning alone included over two dozen eye drops from big name retailers such as CVS Health, Rite Aid, and Target.

FDA action on eye drop products seemingly started to ramp up following an initial warning by the agency back in February that warned of at least one death linked to products contaminated with bacteria.

The agency has also regained the ability to conduct more in-person inspections of manufacturing facilities, following a lull during the pandemic. In fact, the FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections, according to the Government Accountability Office.

In the most recent case, the FDA found “insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility,” according to the warning issued by the agency.

These inspections occur periodically to ensure the quality and safety of products – akin to a surprise food inspector at a restaurant.

“FDA has an algorithm that they use…kind of a risk-based model where they pick and choose the facilities that they inspect based on kind of the level of risk,” Erin Fox, the associate chief pharmacy officer at University of Utah Health, told ABC News.

“In general, it should happen like every three years on average, but some are inspected more frequently than others,” Fox added.

While the FDA is charged with regulating over the counter products, it has limited legal authority to issue a mandatory recall, often times leaving the decision whether or not eye drops are pulled from shelves to the manufacturers or retailers.

“The FDA can’t, in general, force any company to recall a product or a drug product, whether it’s OTC or prescription. That’s why, like, a lot of times when you see a recall, notice, you’ll see it’s a voluntary recall,” Fox said.

In fact, the federal agency can only issue mandatory recalls for a few kinds of products including infant formula, medical devices, food, tobacco products, electronic products, controlled substances, biological products and, more recently, cosmetics, according to an FDA spokesperson.

There are also instances where mandatory recalls can be issued for false marketing of product efficacy, according to Teresa Murray, a consumer watchdog with U.S. Public Interest Research Group.

“So conceivably, the manufacture could sell like a daily vitamin that contains some kind of bacteria and the FDA would not be able to do a mandatory recall. But if the label says that the vitamin will help you live 1000 years, then the FDA could do a recall for false marketing,” Murray said.

If a manufacturer or retailer won’t comply with a mandatory recall, some of the only recourse regulators like the FDA have at their disposal are civil penalties.

“There’s a process where they can go ahead and file a civil action, take a company to court and say, okay, you’re not going to comply, doggone it, we’re going to take you to court. But then, of course, that’s a long protracted process, and it costs, frankly, money and resources that these regulators don’t have,” Murray said.

Along with the lack of authority to issue mandatory recalls, voluntary recalls can sometimes take an extensive period of time to be issued.

“A lot of times, the regulator and the company, and all of their team of lawyers will negotiate the wording of the recall. And that can take days or weeks,” Murray said.

In the meantime, the FDA can put out a warning, as the many that have been issued for contaminated eye drops.

Multiple bills have been introduced in Congress to broaden the FDA’s ability to issue mandatory recalls for prescription and over the counter medicines, such as the Protecting Americans from Unsafe Drugs Act, yet none have made it into law.

Eye drops that have been listed as contaminated should not be purchased or used and should be disposed of, according to the FDA.

“If anyone using these drops has eye discharge, redness or pain (i.e. signs of infection) they should see an ophthalmologist immediately,” said Dr. Christopher Starr, an associate professor of ophthalmology at Weill Cornell Medicine and spokesperson for the American Academy of Ophthalmology told ABC News.

Eye drops can also expire, where they pose a higher risk of contamination.

“I remind everyone to also check expiration dates of their eye drop bottles. If expired, please discard them, as there is a higher risk of contamination even with non-recalled, well-manufactured eye drops,” Starr added.

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