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What is causing the FDA's backlog in drug inspections?
The FDA's inspection backlog began in early 2020 when the agency halted inspections due to the COVID-19 pandemic. Nearly five years later, the FDA has not returned to inspect about 2,000 pharmaceutical manufacturing plants, which represents 42% of registered drug facilities. This situation is exacerbated by staffing shortages and resource constraints within the agency.
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How does this backlog affect drug safety?
The backlog poses significant risks to drug safety as it increases the likelihood of contamination and quality issues in medications. Without regular inspections, there is a greater chance that unsafe or substandard drugs could enter the market, potentially affecting millions of Americans who rely on these medications.
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What are the potential risks for consumers?
Consumers face several risks due to the FDA's inspection backlog, including exposure to contaminated drugs and compromised quality. Experts warn that the pressure on generic drugmakers to cut costs could lead to further quality issues if inspections are not conducted regularly, raising concerns about the overall safety of the U.S. drug supply.
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What steps is the FDA taking to resolve this issue?
The FDA is aware of the backlog and is working to address it by increasing staffing and resources for inspections. However, the timeline for fully resolving the backlog remains uncertain, and the agency continues to emphasize that the U.S. drug supply is still among the safest globally, despite the challenges.
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What can consumers do to stay informed about drug safety?
Consumers can stay informed about drug safety by regularly checking the FDA's website for updates on inspections and recalls. Additionally, they should consult healthcare professionals about the medications they are taking and report any adverse effects to the FDA to help ensure drug safety.