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The Role of the FDA in Regulating Eye Drops to Prevent Contamination

Product Defect

Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial infections since 2023.

The U.S. Food and Drug Administration (FDA) recognizes these risks. As it states, eye drops present, “a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.” But, while the FDA regulates eye drops (and all other medical products sold in the United States), its ability to prevent contaminated eye drops from landing on pharmacy shelves is limited.

This makes it extremely important for consumers and families to be vigilant about protecting their health and their legal rights. Consumers, parents and other family members can check for eye drop recalls through the FDA’s website, and they should seek a diagnosis at the first sign of a possible infection. After receiving a diagnosis of a contamination-related infection, it is critical to speak with an attorney about your (or your family’s) legal rights as well—as the financial and non-financial costs can be substantial.

FDA Regulation of Eye Drops: How the Government Can (and Can’t) Help Prevent Contamination

The FDA is the federal agency responsible for regulating the sale of medical products (including eye drops) in the United States. It has several legislative and regulatory tools at its disposal, and it has the authority to conduct inspections, send Warning Letters, and initiate recalls as necessary.

But, the FDA’s ability to regulate the sale of contaminated eye drops is also inherently compromised. The FDA can only do so much when it comes to proactively ensuring compliance; and, even once a problem has been discovered, the FDA must follow certain processes and procedures—which often means that companies can continue to manufacture and sell contaminated products for years. Unfortunately, this often means that consumers and families don’t learn about dangers until it is already too late.

With this in mind, here is an overview of some of the FDA’s primary tools and resources for regulating eye drops to prevent contamination:

The Food, Drug and Cosmetic Act (FDCA)

The Food, Drug and Cosmetic Act (FDCA) is the primary source of the FDA’s enforcement authority. This federal statute imposes several requirements for manufacturers that are specifically intended to ensure the safety of eye drops and other medical products. All eye drop manufacturers must fully comply with the FDCA, and the FDA has the authority to enforce compliance once it discovers a violation that puts consumers’ or patients’ health at risk.

Premarket Approval (PMA)

The FDA’s premarket approval (PMA) process is also designed to help prevent dangerous medical products from ending up on pharmacies’ and health care providers’ shelves. However, this process has been substantially eroded over the years, thanks in large part to lobbying by the medical industry. Today, manufacturers can secure approval without going through the FDA—whether they work with a third party examiner or self-certify compliance.

Current Good Manufacturing Practice (CGMP) Regulations

The FDA’s Current Good Manufacturing Practice (CGMP) regulations work with the FDCA to establish companies’ compliance obligations when manufacturing eye drops and other medical products. Even more so than the FDCA, the CGMP regulations are focused on ensuring that all medical products are manufactured in a safe and sterile environment that prevents contamination and other risks. As the FDA explains:

“[The] FDA ensures the quality of drug products [including eye drops] by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. The CGMP regulations . . . contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.”

Compliance with the CGMP is mandatory for eye drop manufacturers, as noncompliance can have severe—and even life-threatening—consequences. Yet, noncompliance is common, and the FDA often only takes action after learning that a manufacturer is selling contaminated or adulterated products.

Manufacturing Facility Inspections

The FDA has the authority to inspect manufacturers’ facilities in various circumstances. This includes conducting inspections during the PMA process, conducting inspections to assess CGMP compliance and conducting inspections in response to safety concerns. Following these inspections, the FDA can take remedial actions ranging from mandating compliance before issuing approval to issuing recall notices and Warning Letters.

Voluntary and Mandatory Recall Notices

Recalls are critical for removing contaminated eye drops and other dangerous medical products from circulation. While the FDA usually issues voluntary recall notices to manufacturers, it also has the authority to institute mandatory recalls when necessary to protect the public. Since early 2023, the FDA has issued recall notices to several companies related to their manufacturing and sale of contaminated eye drops.

Warning Letters

When manufacturers and other companies don’t comply with recall notices or the FDA’s inspection findings, the FDA’s next step is usually to issue a Warning Letter. Warning Letters serve as formal notice of non-compliance; and, if a company ignores a Warning Letter from the FDA, the next step is usually enforcement action.

What Consumers and Families Can Do to Recover the Costs of Infections from Contaminated Eye Drops (and Help Prevent Future Contamination)

Even if the FDA eventually takes enforcement action against an eye drop manufacturer, this does nothing to help those who have already suffered adverse consequences due to contaminated eye drops. Instead, victims and their families must take legal action of their own. By filing lawsuits to hold companies accountable for manufacturing and selling contaminated eye drops, not only can victims and families recover just compensation, but they can also give these companies a financial incentive to avoid selling contaminated products in the future.

Schedule a Free Consultation with a Contaminated Eye Drop Lawyer at Searcy Denney

If you need to know more about filing a lawsuit related to contaminated eye drops, we strongly encourage you to get in touch. We represent individuals and families nationwide, and we have helped numerous clients obtain just compensation for harm caused by dangerous and defective products. To learn more in a free and confidential consultation, give us a call at 800-780-8607 or request an appointment online today. 

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Posted By: Lauren Schumacher