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Pandemic forces are sharply cutting off FDA inspections of the drug company

Proponents of remote auditing say they can do the same thing virtually. Peter Miller, president of Dynamic Compliance Solutions in New Jersey, who helps life science companies comply with FDA regulations, says his remote audit suite can do a great job of checking. The set has a small 360-degree camera that the host carries on the tripod while the investigator looks at the computer screen.

“The inspector may say, ‘I see a box of boxes there.’ Can we get some closer “I would like to see if they have the appropriate stickers,” he said. “I think the auditor should be in control of what they look at. We broadcast live, unregistered. “

Industry advocates believe the FDA is too deceptive to reject remote controls in light of available resources. Mark I. Schwartz, a former FDA deputy director who oversaw inspections conducted by the agency’s Biological Assessment and Research Center, said the wider use of remote controls was out of date. Mr Schwartz believes that, once properly done, remote controls will yield results similar to a person’s visit, which he says has been done by more than a dozen clients.

“The suggestion that being on the ground is a hell of a thing is a hoax,” said Mr. Schwartz, now director of Hyman, Phelps & McNamara, a law firm in the pharmaceutical industry. At best, Mr. Schwartz said, investigators see only about 15 percent of the company on the ground, even when they are there in person.

The issue has caught the attention of Congress. Dr. Denigan-McCauley is scheduled to testify Tuesday in the House Appropriations Subcommittee, which is overseen by FDA Representative Sanford Bishop, a Georgia Democrat who chairs the committee. The efficiency of drug delivery is increasing every day. »

While public health professionals are concerned about the large drop in inspections, most of them believe that virtual inspections will be a bad substitute for personal reviews.

“Remote controls are just not going to cut it,” Dr. Kerom said. “Often the FDA detects serious problems; if you are not there, they will be detected.”


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