Restore Former Inspection Processes: Gortler

Former FDAer David Gortler, who is now a Heritage Foundation senior research fellow, sees a correlation between the increasing number of drug and medical device recalls in the last few years and a change in the way the agency approaches facility inspections. Writing in an online Independent Institute news article, Gertler calls on FDA to “restore its historical, robust, and comprehensive in-person inspection methodology. It must increase transparency to Americans regarding inspection failures and quality concerns. It must actively prioritize independent verification over manufacturer self-reporting and ensure that enforcement actions occur before dangerous products reach American patients — not just passively ‘Tweet’ about it on social media after the recall has taken place.”

Gertler says that almost as soon as the Biden administration took office, FDA career employees proposed an agency-wide remote inspection system for almost everything it regulated. “Recalls began soaring,” he writes, “and continued to do so even after FDA ended its work-from-home policy in 3/2025.” He notes that the agency’s inspection backlog has remained at a steady level in recent years and cites a Government Accountability Office 2/2026 report scolding FDA for not effectively inspecting manufacturing plants.

For decades, Gertler writes, FDA’s drug oversight model depended on in-person inspections of the manufacturing practice and independent verification of product quality. He says the underlying principle was straightforward: companies seeking to profit from selling medicine to the American people would be held to strict and independently assessed FDA-enforced standards. “However,” he adds, “that principle has recently been eroded.”

During COVID, he says, FDA sharply curtailed — then mostly eliminated — routine in-person inspections as part of its work-at-home scheme. “The repercussions are still being felt today,” he asserts, saying that manufacturers know that no FDA inspector will make an unannounced in-person inspection. For example, he says, some 90% of FDA overseas inspections are announced in advance.

“Hardly a weekday goes by without at least one FDA-announced recall,” Gertler says. “It seems that America’s FDA leadership has significant ‘blind spots’ to a surge in product recalls by allowing its ‘remote’ inspection policy to continue as a permanent policy, including to this very day.”

The article contains charts that trace the increase in drug and medical device recalls through the years of FDA work-from-home policies.

“FDA leadership must immediately return to a valid inspection process that made FDA’s historical quality verification the global gold standard,” Gertler concludes. “FDA leadership and its inspectors need to get back to work and do so quickly.”