FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic

FDA Oversight Of Drug Manufacturing Facilities Plunged During Pandemic

June 16th, 2022 // 5:29 pm @

Every year, FDA keeps track of how effectively it inspects drug manufacturing facilities and how often it issues FDA inspection follow-up letters to facilities that have major cGMP problems. But last year, there was a major drop in FDA productivity for inspections and follow-ups.

A recent FDA analysis found that FDA sent out only 70% of the letters that should have been mailed to determine the regulatory classification for drug facilities within three months of the FDA audit. And only about 50% of FDA regulatory moves were done within 180 days for drug manufacturing facilities that had QC problems that needed to be dealt with promptly.

This output from FDA is not nearly as good as in previous years. In 2020, FDA sent out almost 80% of the inspection classification letters within three months of the inspection. It finished 63% of regulatory decisions that needed to be done within six months. And in 2019, FDA issued 87% of follow-up letters and finished 75% of regulatory actions.

The reduction in efficiency and follow-up is interesting because drug companies need the FDA to communicate with them in a timely manner so they can continue to manufacture drugs. This is the case for drug plants that use both API and finished drug products. If they do not get quick follow-up from FDA, drug production can fall behind, which affects profitability and how available drugs are.

One FDAer went on record recently to note that the drop in follow-up letters is significant, and there are real-world consequences to falling behind in this way. Drug applications can be put on hold, or the plant may need to find another supplier. In the worst case, there can be product shortages.

FDA responded to this story by citing staffing issues and fewer inspections because of the pandemic. FDA data shows there were only 951 FDA audits in 2021 compared to 1446 in 2020. The number of pharmaceutical companies that had to fix cGMP issues and are waiting for FDA inspections fell to 465 from 735 in the same timeframe.

This report comes as the agency is being scrutinized by Congress for many reasons, but one of them is that is that FDA isn’t getting drug manufacturing inspections done on time. This issue continues to come up with plants in other nations, such as India, related to poor cGMP practices abroad.

However, FDA is being criticized for its inspections in the US, too. The US Office of Special Counsel criticized FDA last year over four times when FDA downgraded serious cGMP findings at several drug plans. One of them was a Merck plant in the SE US, when a whistleblower told FDA about several sanitary issues.

In that case, an FDA auditor who went to the plant found serious QC and sanitary problems, but his 483 findings were minimized by his supervisors. This was one of the four cases where the agency took months to decide that the companies only needed to take voluntary actions to fix their cGMP problems.

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