A significant FDA inspection backlog is delaying new drug approvals, particularly for drugs manufactured overseas. Exacerbated by the pandemic, the delay in regulatory approval impacts the availability of new treatments in the U.S. and could hinder the introduction of innovative therapies. Although the FDA is working on reducing the backlog, the delays are causing concerns across the pharmaceutical industry.

The following article originally appeared in PharmaVoice.

Inspections of overseas drug manufacturers came to a standstill during the height of the COVID-19 pandemic lockdown. Years later, the backlog of inspections is still high, adding to a host of risks across the pharma industry.

Roughly 2,000 pharma manufacturers haven’t been inspected by the FDA since before the pandemic, according to a recent analysis from the Associated Press. The findings underscore concerns previously voiced by the Government Accountability Office and backed by lawmakers. Meanwhile, quality issues have piled up, impacting some new drug approvals.

“Every few years, Congress calls FDA leaders to testify and explain why inspections aren’t as high as they should be,” said David Ridley, an economics professor at Duke University’s Fuqua School of Business who has studied the FDA’s inspections backlog. “However, these inspections plummeted during the pandemic and still haven’t recovered.”

Last year, a major recall of contaminated over-the-counter eye drops made headlines after four deaths, 14 cases of vision loss and more than 80 infections were reported. The case laid bare the FDA inspections issue, making clear just how dire the consequences could be from a lack of international oversight from regulators. And OTC products are just the tip of the iceberg.

‘A race to the bottom’

As the rate of overseas inspections remains low, U.S. pharmas have faced delays in drug approvals due to problems with third-party manufacturers.

“The backlog has resulted in delayed launches,” Ridley said. “There are some good medicines that got to the patients later.”

In June alone, three FDA rejections were linked to manufacturing. AbbVie’s potential Parkinson’s disease blockbuster faced its second FDA rejection after the regulator flagged concerns with the manufacturing facility during an inspection that didn’t involve AbbVie’s medicines.

That month, Rocket Pharmaceuticals received a rejection for its gene therapy targeting a rare inherited immunodeficiency, and Merck & Co. and Daiichi Sankyo were dealt a complete response letter for their antibody-drug conjugate targeting non-small cell lung cancer — both due to manufacturing-related issues.

Some lawmakers have voiced concerns that part of the challenge isn’t with manufacturers — it’s with the FDA’s inspection program.

In a June letter from Congress to FDA commissioner Dr. Robert Califf, a congressional committee’s analysis on the outcomes of FDA inspections in India and China from 2014 to 2024 were “surprising” due to the variance in outcomes.

“Some FDA inspectors found compliance issues during all or almost all of their inspections,” lawmakers wrote, pointing out that others found none over the course of dozens of inspections. “Such large variations in inspection outcomes are troubling, and they merit further investigation,” they said, suggesting there could be “vast differences in the skill, thoroughness and competence of FDA inspectors.”

With the inspections program in question, generic drugs also pose a risk as they’re often manufactured overseas at lower cost. A lack of inspections could make these drugs more vulnerable to quality issues..

“Generic drugmakers are under so much pressure to cut costs that there’s a race to the bottom, and I worry that some generic drug manufacturers will be tempted to skimp on quality knowing that they’re unlikely to be inspected, especially if they’re thousands of miles away,” Ridley said.

The uphill battle

The FDA has said it’s working to fix the backlog. However, the agency has suffered from understaffing, which could be an obstacle.

“I think FDA leaders have been challenged to find staff that are willing to travel, especially given that the federal government doesn’t pay especially well, Ridley said.”

And if the FDA isn’t able to increase the rate of inspections soon?

“Plan B would be drug retailers or wholesalers taking some responsibility for pharmaceutical quality,” Ridley said.

Going forward, Ridley said the generic drug sector will be particularly at risk for quality challenges.

“We should be concerned about the quality and efficacy of our generic drugs, because there is very little attention being paid to it, and so there are opportunities for skimping on it,” Ridley said. “We take for granted that our generic drugs are safe and effective.”

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