Enhancing FDA Oversight for Safer Eyedrops: New Powers and Challenges

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When purchasing over-the-counter eyedrops in the United States, consumers trust that these products are manufactured in clean, well-regulated facilities, adhering to the highest standards of quality and safety. However, recent recalls have raised concerns about the limited knowledge U.S. officials have regarding manufacturing conditions in foreign plants and their ability to intervene when issues arise.

The Food and Drug Administration (FDA) is now urging Congress to grant them additional powers, which include the authority to mandate drug recalls and require inspections of eyedrop manufacturers before their products are shipped to the U.S. While these proposed powers seem promising, experts caution that they may be ineffective without the allocation of more resources and staff for foreign inspections, a challenge that predates the COVID-19 pandemic.

David Ridley, a researcher from Duke University, highlights the concerning decline in FDA foreign inspections, with a staggering 79% decrease in 2022 compared to 2019. Although inspections have increased in the current year, they still fall significantly below pre-pandemic levels.

FDA spokesperson Jeremy Kahn emphasizes that while the FDA strives to inspect as many facilities as possible, the responsibility for product quality ultimately rests with the industry.

A pivotal moment in this discussion was the October recall of two dozen eyedrop brands, originating from a Mumbai plant that supplied products to major retailers such as CVS and Walmart. FDA inspectors discovered unsanitary conditions, including cracked floors and barefoot workers, during their first-ever visit to the facility. This inspection followed an earlier recall associated with a different Indian plant, which had never been inspected and had been linked to fatalities and vision loss cases.

To address these issues and improve the safety of eyedrop products, experts suggest three potential changes:

1. Earlier Inspections: Unlike prescription medicines, over-the-counter products like eyedrops do not undergo preliminary reviews or inspections. They are governed by a system known as a monograph, which allows drugmakers to launch products rapidly once they attest to using the standard recipe. The FDA seeks the authority to require manufacturers of eyedrops and sterile products to provide at least six months’ notice before shipping products from a new factory, allowing inspectors to visit uncharted facilities.

2. Requiring Recalls: The delay in recalling tainted eyedrops at the request of Indian manufacturer Kilitch Healthcare highlights the need for the FDA to have mandatory recall authority over drugs, similar to its authority over food and medical devices.

3. Funding Foreign Inspectors: With drug manufacturing increasingly shifting to lower-cost countries like India and China, the FDA’s oversight of the global supply chain is critical. Experts suggest that Congress should address the challenges of recruiting and retaining overseas inspectors to ensure effective oversight.

In conclusion, the recent incidents involving eyedrop recalls have shed light on the need for enhanced FDA powers and resources to guarantee the safety and quality of such products. While the FDA’s proposals are a step in the right direction, addressing the challenges of foreign inspections and ensuring prompt recalls are crucial to safeguarding public health.

Frequently Asked Questions (FAQs) about FDA Eyedrop Oversight

More about FDA Eyedrop Oversight

• FDA Requests New Powers for Drug Recalls and Inspections – NPR article providing in-depth coverage of the FDA’s request for new powers regarding eyedrop oversight.
• Duke University Research on FDA Inspections – Research by David Ridley from Duke University discussing the decline in FDA inspections of drug manufacturing abroad.
• FDA Statement on Foreign Inspections – Official statement from the FDA regarding foreign inspections and sampling updates.
• FDA Monograph System – Information on the FDA’s monograph system for over-the-counter drugs, including eyedrops.