Suzanne Smalley, Politico: March 2, 2021
The Food and Drug Administration is under increasing pressure from the pharmaceutical industry to address the growing backlog of drug inspections — nearly a year after Covid-19 prompted the agency to halt most plant visits.
From March through September, FDA inspected just three plants outside the U.S., well below the 600-plus it visited in each of the prior two years, the Government Accountability Office said last month. FDA has also struggled to keep up with inspections within U.S. borders, conducting just 52 during the same seven-month period last year, compared with roughly 400 each in 2019 and 2018.
Inspections, which are required before a therapy wins FDA approval, are a vital tool to ensure the safety of new drugs as well as medicines already on the market. The work takes FDA inspectors all over the world. More than 70 percent of drug ingredients are manufactured outside of the U.S., largely in India and China. The two countries are also major suppliers of generic drugs.
The effects of the FDA slowdown are already becoming apparent. In recent weeks, the agency has deferred or denied at least six drug approvals because it could not inspect manufacturing sites in the U.S. and abroad. The delayed treatments include drugs for endometrial cancer and abnormally low levels of white blood cells, a condition often linked to cancer treatment; a regenerative skin therapy for adults with deep second-degree burns; and a cholesterol drug for people who cannot tolerate statins.
“There’s a huge backlog of drugs and biologics facilities that have not been inspected and it is affecting the public health. The agency doesn’t really seem to care and we are now approaching the one year point,” said Mark Schwartz, a lawyer at Hyman, Phelps & McNamara in Washington, D.C., who represents drug companies. “It is irresponsible for the gold standard of regulatory bodies to be dithering while pharma is burning.”
FDA spokesperson Jeremy Kahn said that the agency continues to perform what it calls “mission critical” inspections and is using record reviews and outside regulator reports to replace in-person visits where possible. While several drugs’ applications for approval have been deferred due to the lack of inspections, Kahn said the FDA has not experienced “a significant impact on its ability to take action on drug applications.”
“The FDA believes that maintaining oversight of manufacturing operations is critical to ensuring drugs remain safe and effective,” Kahn said in a statement. “The health, safety and well-being of all Americans — including our investigators — are of utmost importance to the FDA.”
Lawyers representing the industry have pressed the FDA to consider using virtual inspections since the pandemic began, but they say the agency has been noncommittal. Donald Ashley, the director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, told an industry conference in December that he worried remote inspections could miss problems.
While the GAO report only documented drug inspection backlogs, agency watchdogs said the problem extends to medical devices as well. Diana Zuckerman, president of the National Center for Health Research, said she is particularly disturbed by the device backlog because devices typically do not undergo clinical trials, leaving inspections as the primary tool for assessing safety and effectiveness.
Earlier this month, a division within the FDA’s Office of Regulatory Affairs gave Zuckerman a Zoom briefing on its inspections of medical devices. She said three officials presented her with their 2019 inspection numbers and omitted 2020, which is when the pandemic hit and inspections largely stopped.
“I said, ‘Well, that’s very interesting about 2019, but what about 2020?’” Zuckerman said. “And I said I understand how difficult it is to do inspections during a pandemic, and they said basically they don’t do them.”
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