Pandemic Forces F.D.A. to Sharply Curtail Drug Company Inspections

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Proponents of remote audits say they can do the same thing virtually. Peter Miller, president of Dynamic Compliance Solutions, of New Jersey, which helps life science companies comply with F.D.A. regulations, says his remote audit kit can do a great inspection. The kit features a tiny 360-degree camera, which an on-site host carries on a tripod while the investigator watches on a computer screen.

“The inspector can say, ‘I see a stack of boxes there. Can we move a little closer? I’d like to see if they have proper stickers,’ ” he said. “I believe the auditor should be in control of what they are looking at. We do a livestream, unrecorded broadcast.”

Industry lawyers believe the F.D.A. is being too fussy in rejecting remote inspections, given the current backlog. Mark I. Schwartz, a former F.D.A. deputy director who had oversight of inspections conducted by the agency’s Center for Biologics Evaluation and Research, thinks wider use of remote inspections is way overdue. Mr. Schwartz believes that when done properly, remote inspections will yield similar results to in-person visits — which he said more than a dozen of his clients are desperate to have done.

“The suggestion that being on-site makes a whole hell of a difference in finding things is a fallacy,” said Mr. Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large pharmaceutical industry practice. At best, Mr. Schwartz said, investigators on-site see only about 15 percent of a company even when they are there in person.

The issue has drawn congressional attention. Dr. Denigan-Macauley is scheduled to testify on Tuesday before the House appropriations subcommittee that oversees the F.D.A. Representative Sanford Bishop, a Georgia Democrat who is chairman of the panel, said, “The pressure to ensure F.D.A. is still able to assess the safety and efficacy of the drug supply grows every day. ”

While public health experts are troubled by the big drop in inspections, most believe that virtual inspections would be a poor substitute for in-person reviews.

“Remote inspections just aren’t going to cut it,” Dr. Carome said. “Often the F.D.A. identifies serious problems and if you aren’t on-site, those will go undetected.”

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