NEW DELHI – The recent recalls of over-the-counter eyedrops have raised concerns about the safety and quality of products manufactured in other countries and sold in the U.S. The FDA is seeking new powers to address these issues, but experts say that without additional resources for foreign inspections, these capabilities may not be enough.
According to FDA records, foreign inspections were down 79% in 2022 compared to 2019, and while they have increased this year, they are still below pre-pandemic levels. This decline in inspections has raised concerns about the safety of products coming from overseas.
One of the recent recalls was prompted by unsanitary conditions at a Mumbai plant, which supplied products to major retailers in the U.S. This has led to calls for earlier inspections of manufacturing facilities, especially for over-the-counter products like eyedrops, which currently do not undergo preliminary review or inspections.
Earlier inspections
Unlike prescription medicines, over-the-counter products like eyedrops do not undergo preliminary review or inspections. The FDA is asking Congress for the power to require manufacturers of these products to give at least six months notice before shipping products from a new factory, allowing inspectors time to visit facilities that aren’t on their radar.
Dr. Sandra Brown of the Dry Eye Foundation advocates for increased regulation, stating that the unique risks of tainted eyedrops require a different approach from pills and tablets.
Requiring recalls
The FDA currently lacks the authority to force recalls of drugs and instead must ask companies to voluntarily take action. The agency has asked Congress for mandatory recall authority over drugs to address this issue.
Funding foreign inspectors
With drug manufacturing increasingly moving to lower-cost countries, the FDA’s oversight of the global supply chain has become a high-risk issue. The agency has faced challenges in recruiting and retaining overseas inspectors, and experts believe that Congress needs to address this problem by providing resources for staffing inspections.
It is clear that there are significant challenges in ensuring the safety and quality of over-the-counter products like eyedrops, especially those manufactured in other countries. The FDA’s request for new powers and resources is a step in the right direction, but more needs to be done to address the growing concerns about the safety of these products.
Experts advocate for new FDA authority to ensure safer eyedrops following recalls and infections.
Agree. Our eye health should always be a top priority, and stricter regulations would help prevent any future harm caused by contaminated eyedrops.
Agree. Strengthening FDA regulations will safeguard our eye health and restore confidence in the safety of eyedrops. #EyeCareMatters
Disagree. More FDA authority could lead to excessive regulation, negatively impacting innovation and access to new and potentially life-changing eye care products.