Last Updated on September 7, 2024 by The Health Master
Pharma Companies
The U.S. Food and Drug Administration (USFDA) is still grappling with the aftermath of the COVID-19 pandemic, as it seeks to regain its pre-pandemic oversight of the nation’s drug supply by pharma companies.
An analysis by The Associated Press reveals a significant backlog of pharma companies that have not received safety inspections in years, raising concerns about potential contamination and quality issues in medications used by millions of Americans.
A Growing Backlog of Uninspected Pharma Companies
Since the pandemic disrupted pharma companies inspections worldwide, the USFDA has been unable to return to approximately 2,000 pharma companies for surveillance visits.
This represents about 42% of the pharma companies registered to produce drugs in the U.S. and previously inspected by the USFDA before May 2019.
These overdue inspections pose a significant risk to public health, as many of the uninspected pharma companies manufacture critical medications, including antibiotics, blood thinners, and cancer therapies.
According to USFDA guidelines, facilities that haven’t been inspected in five or more years are considered high-risk and should be prioritized for mandatory inspections.
Overseas Manufacturing and Quality Concerns
The majority of the overdue pharma companies are located within the United States, but over 340 are in India and China, two countries that supply a significant portion of the drug ingredients used in low-cost U.S. prescriptions.
This raises concerns about the quality of generic drugs, as manufacturers may be tempted to cut corners to reduce costs.
David Ridley of Duke University, an expert on the pharma industry, warns that “generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality.”
He emphasizes that without regular inspections, it’s difficult to identify potential problems until it’s too late.
Recent Drug Safety Incidents
The risks associated with inadequate oversight of the drug supply were highlighted by a recent outbreak of antibiotic-resistant bacteria caused by tainted eyedrops from an Indian factory.
This incident resulted in the hospitalization of over 80 Americans, four deaths, and the blindness of more than a dozen people.
Notably, the factory responsible for the contaminated eyedrops was never registered with the USFDA.
Prior to the pandemic, numerous recalls of common medications were linked to contamination with cancer-causing substances.
These incidents underscored the importance of rigorous inspections and oversight of both domestic and foreign drug manufacturing facilities.
USFDA’s Efforts and Challenges
The USFDA has increased its drug inspections each year since 2021, prioritizing foreign factories.
However, the number of inspections conducted last year was still significantly lower than pre-pandemic levels.
The agency has attributed this shortfall to a wave of staff departures, including experienced inspectors who have found new jobs with more flexible work arrangements.
The USFDA has also faced challenges in conducting inspections during the pandemic, as it had to halt all but the most critical visits to prioritize essential medical supplies.
While the agency has gradually resumed inspections, regular international visits did not fully resume until 2022.
To address these challenges, the USFDA has been using video and other online tools to evaluate pharma companies remotely.
However, these virtual inspections are not as effective as in-person visits in ensuring compliance with safety and quality standards.
The Need for Enhanced Oversight
The Government Accountability Office has consistently identified the USFDA’s oversight of the global pharmaceutical supply as a high-risk issue since 2009.
The increasing reliance on overseas manufacturing has made it more challenging for the USFDA to monitor drug quality and safety.
To effectively address these challenges, the USFDA must invest in its workforce, expand its international presence, and develop more robust inspection protocols.
By strengthening its oversight capabilities, the agency can help ensure the safety and efficacy of the drugs that Americans rely on.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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