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

Remote exam advocates say they can do the same thing virtually. Peter Miller, president of New Jersey-based Dynamic Compliance Solutions, which helps life science companies comply with FDA regulations, says his remote audit kit can do an excellent inspection. The kit includes a tiny 360-degree camera that 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 over there. Can we get a little closer I would like to see if they have the right stickers, ”he said. “I believe the examiner should be in control of what he sees. We’re doing a live stream, an unrecorded broadcast. “

Industry lawyers believe the FDA is too picky about the current backlog to refuse remote inspections. Mark I. Schwartz, a former FDA assistant director who oversaw inspections by the agency’s Center for Biologics Evaluation and Research, believes wider use of remote inspections is overdue. Mr Schwartz believes remote inspections, if done properly, will produce results similar to face-to-face visits – which he said more than a dozen of his customers are dying to do.

“To suggest that being there makes a big difference is a fallacy,” said Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large practice in the pharmaceutical industry. At best, according to Schwartz, the on-site investigators only see around 15 percent of a company, even if they are there in person.

The subject caught the attention of Congress. Dr. Denigan-Macauley, due to testify Tuesday before the budget subcommittee that oversees FDA Representative Sanford Bishop, a Georgia Democrat who chairs the panel, said, “The pressure to ensure the FDA continues to assess safety and security The effectiveness of the drug supply is growing day by day. ”

While public health experts have been hit by the sharp decline in inspections, most believe virtual inspections are a poor substitute for in-person reviews.

“Remote inspections are just not going to make it,” said Dr. Carome. “Often times the FDA identifies serious problems and when you are away they go undetected.”

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