The recent string of recalls involving over-the-counter eyedrops in the United States has shed light on the lack of oversight and regulation of manufacturing plants overseas.
Consumers expect that the products they purchase have been made in clean and well-maintained facilities that meet health and safety standards.
However, the reality is that U.S. officials have limited knowledge of the conditions at some of these foreign manufacturing plants and lack the necessary tools to intervene when issues arise.
The Food and Drug Administration (FDA) has recognized the need for new powers to address this issue and is seeking support from Congress.
One of the proposed powers is the ability to mandate drug recalls, which would provide the FDA with more control over addressing safety concerns with over-the-counter medications.
Additionally, the FDA is seeking the authority to require eyedrop manufacturers to undergo inspections before shipping their products to the U.S. These proposed powers are crucial steps in improving the oversight of foreign manufacturing plants and ensuring the safety of products imported into the country.
However, simply granting the FDA new powers will not be sufficient to address the issue at hand. The lack of resources and staff for foreign inspections has been a longstanding challenge for the FDA, and the situation has been exacerbated by the COVID-19 pandemic.
The pandemic forced regulators to forgo thousands of planned visits to foreign manufacturing plants, further limiting their ability to ensure compliance with regulations and standards.
David Ridley, a co-author of a recent paper on the decline in FDA inspections, highlighted the agency’s shortcomings in ensuring drug quality assurance inspections abroad.
He noted that very few foreign drugmakers have been inspected in the past four years, indicating a significant gap in oversight and regulation.
To effectively address these challenges, the FDA will require additional resources and staff to conduct thorough and regular inspections of foreign manufacturing plants.
This will not only improve the agency’s ability to monitor and enforce compliance with regulations but also enhance the safety and quality of products imported into the U.S. market.
In conclusion, the recent recalls of over-the-counter eyedrops in the U.S. have underscored the need for stronger oversight and regulation of foreign manufacturing plants.
While the FDA’s proposed new powers are a step in the right direction, addressing the underlying challenges will require additional resources and staff for foreign inspections.
It is imperative that Congress and regulatory agencies work together to strengthen the oversight of foreign manufacturing plants and ensure the safety and quality of products available to consumers in the United States.
The repeated recalls of over-the-counter eyedrops have brought to light the concerning lack of knowledge that U.S. officials have about the conditions at certain manufacturing plants.
This issue has prompted the FDA to request new powers from Congress, although experts are skeptical that these capabilities will be effective without additional staff and resources.
In October, U.S. health regulators issued a warning to consumers to avoid using more than two dozen varieties of eyedrops that were associated with infections potentially leading to blindness.
Surprisingly, these eyedrops were not recalled until the following month. One of the key powers that the FDA is seeking is mandatory recall authority, which is currently not available for drugs.
This would enable the FDA to swiftly recall contaminated drops and prevent further harm to consumers. It is evident that there is a pressing need for improved oversight and regulatory measures in order to safeguard public health.
In 2022, the FDA’s foreign inspections experienced a significant decline, dropping by 79% from 2019, as per the records compiled by Ridley’s group.
While there has been a rise in inspections this year, they still remain notably lower than the levels observed before the pandemic. Jeremy Kahn, a spokesperson for the FDA, emphasized the agency’s commitment to inspecting as many facilities as possible, while also stressing that the industry holds ultimate responsibility for the quality of their products.
Notably, an October recall involving two dozen eyedrop brands was prompted by FDA staff’s discovery of unsanitary conditions, including cracked floors and barefoot workers, at a Mumbai plant that supplied products to major retailers such as CVS and Walmart.
This marked the first visit by FDA staff to the site, underscoring the significance of such inspections in upholding product quality and safety standards.
The recent inspection was initiated as a result of a previous recall of contaminated eyedrops from a different Indian plant, which has been linked to four deaths and over a dozen cases of vision loss.
It is worth noting that this plant had never undergone a prior inspection. Dr. Timothy Janetos, an ophthalmologist at Northwestern University, emphasized the importance of addressing these rare but harmful instances, stating that changes need to be implemented.
Experts have identified three potential changes, with the first being earlier inspections. Given the high level of regulation surrounding prescription medicines, including the requirement for FDA review to ensure safety and effectiveness, it is crucial for the FDA to conduct inspections of the factories where these drugs are manufactured. This proactive approach could help prevent similar incidents in the future.
The Food and Drug Administration (FDA) has indicated that it possesses the necessary flexibility to adapt its review process in order to uphold and ensure the safety of various products under its purview.
However, the agency has recently proposed to Congress the need for expanded authority, specifically aiming to mandate manufacturers of sterile products, such as eyedrops, to provide a minimum of six months advance notice prior to commencing the shipment of products from a new manufacturing facility.
This proposed regulation is designed to afford the FDA ample time to conduct thorough inspections of facilities that may not have previously been on their surveillance radar.
The primary goal behind this request is to bolster the agency’s oversight and regulatory capabilities, thereby fortifying the safety and quality of sterile products entering the market.
By instituting this advance notification requirement, the FDA aims to proactively address potential risks and ensure a higher level of scrutiny in the production and distribution of such critical medical products.
This proposed measure underscores the FDA’s commitment to maintaining the highest standards of safety and efficacy in the pharmaceutical industry, ultimately safeguarding the well-being of consumers and patients reliant on these essential medical products.
The proposal to implement preapproval inspections for over-the-counter drugmakers may encounter resistance from some within the industry who are not accustomed to such measures.
However, according to Brown, the unique risks associated with tainted eyedrops necessitate a different approach compared to pills and tablets.
Brown emphasized the potential danger of using contaminated products in the eyes, as opposed to products that are ingested and come into contact with stomach acid.
This distinction highlights the need for heightened scrutiny and regulation of eyedrop products. In light of recent events, such as the FDA’s warning against the use of certain eyedrops sold at major retailers, it is evident that there is a need for more stringent measures to ensure the safety of consumers.
The delayed recall of the tainted eyedrops further underscores the urgency of implementing preapproval inspections to prevent similar incidents in the future.
It is concerning to learn that Indian manufacturer, Kilitch Healthcare, initially declined to cooperate with the FDA.
The fact that the FDA lacks mandatory recall authority over drugs is alarming, especially considering the increasing globalization of drug manufacturing in lower-cost countries such as India and China.
The Government Accountability Office’s ongoing concerns about the FDA’s oversight of the global supply chain only adds to the urgency of the situation.
The FDA’s statement about using “all available tools” to ensure the safety and effectiveness of medications is reassuring, but it is clear that more needs to be done to address the challenges posed by the global nature of drug manufacturing.
The decision to prioritize inspections of factories that have never been inspected or haven’t been inspected in the last five years is a step in the right direction, but the halt of routine, in-person foreign inspections in March 2020 due to the COVID-19 pandemic is concerning.
The fact that the agency did not conduct any inspections in India during the first year of the pandemic is particularly troubling.
The challenges faced by the FDA in recruiting and retaining overseas inspectors are understandable, but it is imperative that Congress takes action to address this issue.
As Ridley, the Duke researcher, pointed out, federal hiring is slow and pay is often not competitive. Congress must work to help the FDA solve this problem and hold them accountable for staffing inspections.
In conclusion, it is clear that there are significant challenges in ensuring the safety and effectiveness of medications in the global supply chain.
The FDA’s request to Congress for mandatory recall authority over drugs is a step in the right direction, but more needs to be done to address the issues raised by the Government Accountability Office and other experts.
It is crucial that Congress takes action to support the FDA in recruiting and retaining overseas inspectors to ensure the safety of medications for all Americans.