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

Supporters of remote audits say they can actually do the same thing. Peter Miller, president of Dynamic Compliance Solutions of New Jersey, which helps life science companies comply with FDA regulations, says their remote audit kit can make a great inspection. The kit has a small 360-degree camera, which an on-site host takes on a tripod, while the investigator stares at a computer screen.

“The inspector might say, ‘I see a pile of boxes there. Can we get a little closer? I want to see if they have the appropriate stickers,” he said. “I believe Auditors need to be in control of what they are watching. We do a livestream, without broadcasting. “

Industry lawyers believe the FDA is too fussy to dismiss remote inspections, which are considered to be the current backlog. Mark I. Schwartz, a former FDA deputy director who oversaw inspections conducted by the agency’s Center for Biologics Evaluation and Research, believes the widespread use of remote inspections is overdue. Mr Schwartz believes that when done properly, remote inspections will yield similar results to in-person visits – which he said are more than a dozen of his customers are desperate to do.

“The suggestion that being on the site makes a whole hell of a difference in finding things is a downfall,” 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 see only 15 percent of the company on the site when they are in person.

This issue has caught the attention of Congress. Dr. Denigan-Macaulay is scheduled for bear witness On Tuesday, before the House appropriation overseeing FDA representative Sanford Bishop, a Georgia Democrat who heads the panel said, “The pressure to ensure the FDA is still able to assess the drug’s safety and efficacy every day is increasing.” . “

While public health experts are troubled by the large decline in inspections, most believe virtual inspections would be a poor choice for individual reviews.

“Remote inspections are not just going to cut it,” Dr. Chrome said. “Often the FDA identifies serious problems and if you are not on site, they will be undefined.”

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