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Home | Alert | The Devil You Don’t Know: FDA . . .

The Devil You Don’t Know: FDA Issues Enforcement Action Based on Non-FDA Inspection

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PHILADELPHIA — International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says. While “mutual recognition” of inspections is not yet a reality, drugmakers shouldn't expect the FDA to close its eyes to negative inspection findings from other regulators.

In one instance, the agency has even used another country's inspection data to take regulatory action, Justina Molzon, CDER's associate director for international programs, said at the Drug Information Association annual meeting here. The FDA did not conduct its own independent investigation in this case, Molzon said.

While Molzon declined to provide additional details, “it could have been an urgent situation,” she said. She referred further inquiries to the agency's press office, which did not return a request for comment by press time.

On the flip side, if the FDA is aware that another agency, particularly the European Medicines Agency (EMA), has recently inspected a manufacturer or clinical trial and nothing major came up, that site would become a lower priority for the FDA's in-house inspectors as they work toward a risk-based approach for inspections, Molzon added. 

The agency has also conducted some pilot joint inspection programs. These include an FDA-EMA program for finished drug products inspections and an FDA, EU and Australian active pharmaceutical ingredient GMP inspection initiative.

But it's unlikely that companies will see the FDA move toward blanket mutual recognition of other government authorities' actions anytime soon. “Mutual recognition is a much higher bar … [it] has too much baggage,” Molzon said. “You have to through all these equivalent evaluations and that's a lot of work and effort.”

FDA Commissioner Margaret Hamburg has called for greater trust and more transparency among international regulators to safeguard the world's drug supply chains. Hamburg said countries don't need to have the same standards to achieve results, but minimum standards need to be established, and regulators need to ensure the integrity and comparability of outcomes. — June 2012