Federal agencies tasked with ensuring the safety of the U.S. drug supply are still grappling with a significant inspection backlog, as revealed by an Associated Press (AP) investigation. This backlog has persisted since the onset of the COVID-19 pandemic, which disrupted factory inspections both domestically and internationally.
According to an AP review of Food and Drug Administration (FDA) data, approximately 2,000 pharmaceutical manufacturing facilities have not been inspected by FDA staff since before the pandemic. This gap in inspections heightens the risk of drug contamination and other safety issues for millions of Americans.
The overdue inspections pertain to around 42% of the 4,700 registered drug manufacturing plants that had previously been reviewed by the FDA before May 2019. These plants are responsible for producing essential medications, including antibiotics, blood thinners, and cancer treatments.
The FDA’s own regulations classify factories that have not been inspected in over five years as high-risk and in need of “mandatory” inspections. While the majority of these overdue plants are located within the U.S., over 340 are situated in India and China—two countries that are major sources of drug ingredients for cost-effective U.S. prescriptions.
David Ridley from Duke University highlights the potential dangers, noting that cost-cutting pressures on generic drug manufacturers could lead to compromised quality. “Without regular inspections, we might not discover these issues until it’s too late,” he warned.
A recent incident underscores these concerns: tainted eyedrops from an unregistered Indian factory caused an outbreak of antibiotic-resistant bacteria in the U.S., resulting in four deaths and severe eye damage for more than a dozen individuals.
Prior to the pandemic, the FDA had recalled numerous common medications due to the presence of cancer-causing contaminants. The agency’s first overseas offices were established in 2008 following deaths linked to a contaminated blood thinner from a Chinese facility.
FDA Associate Commissioner Michael Rogers acknowledged the ongoing inspection challenges but emphasized that the agency has increased inspections since 2021, prioritizing foreign plants. Nonetheless, last year’s inspection numbers were still nearly 40% below pre-pandemic levels, with the FDA averaging around 4,300 inspections annually before the pandemic.
The FDA’s efforts have been hampered by staff shortages and high attrition rates, with many experienced inspectors leaving for better-paying positions that often offer remote work options. The agency currently faces 225 vacancies in its inspection workforce—nearly quadruple the number before the pandemic.
The FDA paused most inspections in March 2020, resuming only critical inspections that year and restarting regular international visits in 2022. During the pandemic, the agency utilized remote tools like video calls to evaluate plants, though these methods fall short of in-person inspections.
The Government Accountability Office (GAO) has consistently flagged the FDA’s oversight of the global pharmaceutical supply as a “high risk” area since 2009. The shift of drug manufacturing overseas, initially to Puerto Rico and later to Asia, has posed ongoing challenges for the FDA in keeping pace with evolving global practices.
Dr. Stephen Ostroff, former chief scientist at the FDA, emphasizes the need for adaptation to the global manufacturing landscape. “We need to ensure we can access and assess these facilities, particularly in India and China,” he said.
The FDA maintains a confidential list of facilities for inspection, prioritizing them based on risk. The AP’s analysis, compiled from public records and pre-pandemic inspection data, shows that many overdue plants have not been inspected since before COVID-19. The agency has increased its list of inspection sites by 14% in the past five years.
Despite the challenges, the FDA asserts that it prioritizes inspections based on public health risk. However, only 6% of sites inspected globally last year had serious issues, with violations being notably higher in India.
Political tensions have further complicated inspections in China, where only two full-time FDA inspectors are based. Former FDA officials report that visa issues have hindered inspection efforts.
The FDA is exploring strategies to improve inspection capabilities, including offering additional incentives to retain experienced staff and enhancing travel conditions for inspectors. However, the backlog and staffing issues remain significant obstacles.
Lawmakers have raised concerns about the FDA’s inspection practices, questioning why high-priority inspections in Asia are reporting fewer violations compared to pre-pandemic times. FDA officials maintain that inspection protocols remain stringent and that drug shortage management is handled separately from inspection decisions.
In a novel approach, the U.S. Defense Department has partnered with Valisure, a private lab, to test critical drugs for contaminants and other issues. Initial findings from this pilot program indicate serious flaws in about 10% of tested drugs.
Experts suggest that the FDA’s traditional inspection model, reliant on physical inspections and paperwork, may not fully address the complexities of global drug manufacturing. Some advocate for incentivizing U.S. drug purchasers to source from high-quality manufacturers to enhance safety.
Dr. Kevin Schulman of Stanford University proposes that re-evaluating the FDA’s regulatory framework could address these challenges. “Perhaps this situation will prompt a necessary shift in how we manage global drug safety,” he said.
