Photos Snapped During FDA Device Inspections: Fair Game Or Agency Overreach?
• By Shawn M. Schmitt
FDA says it has the authority to take photographs during facility inspections, citing decades-old non-medical-device-related legal cases as evidence – including Dow Chemical Co. v. US – but industry lawyer Robert Klepinski says FDA's reliance on the Dow case as a defense for snapping pictures doesn't pass muster. "The agency always cites the Dow Chemical case, wherein the EPA flew over [Dow's plant] with a helicopter or airplane and took pictures," Klepinski said, noting that "it’s absolutely ludicrous, a stupid case to cite" because FDA investigators don't inspect device firms from the air. Meanwhile, the agency doesn't have a policy in place that addresses investigators' personal cameras, such as phone cameras, which throws into question whether photos could unintentionally – or intentionally – fall into third-party hands. Also, device-maker Cynosure's VP of regulatory affairs, Connie Hoy, talks about how her company handles photo requests made by investigators.
"We believe it’s our right to [take photos]. We believe it’s an inspection tool, much like other tools that we use, like the computer, for example," FDA National Device Expert and investigator Phil Pontikos said.
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The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
