Drugmakers Should Review Policies for Photos, Interviews

Drugmakers should review their inspection standard operating procedures for producing off-site records and allowing FDA investigators to take photos or conduct interviews of employees, following new agency guidance on the topics.

The guidance clarifies that if a company refuses to allow photos or interviews or can’t provide off-site records, the FDA will consider that to be delaying or refusing an inspection and the firm’s products could be deemed adulterated.

Companies should be prepared to deal with investigators who are more assertive in these areas, said a legal expert who spoke at a recent FDAnews webinar.

FDA investigators have long been instructed that existing court precedents grant them the power to take photographs of a facility, but numerous attorneys have disagreed with that interpretation, said Lynn Tyler, a partner at the law firm Barnes and Thornburg.

“Most companies didn’t refuse photographs anyway, but now it appears the FDA has a more solid basis for saying they are authorized,” he said.

The FD&C Act also doesn’t expressly grant investigators the power to interview employees. However, the guidance makes clear that FDA investigators will expect employees to be available for interviews, except in cases where the company can provide an acceptable explanation for not having them available, such as personnel aren’t at work at the beginning of an unannounced inspection.

Tyler also doubts the FDA has the power to require facilities to produce records stored at another site, as the FD&C Act only says that facilities must provide records stored on site. Nonetheless, he encourages companies to comply with record requests whenever possible.

Tyler recommends caution if an investigator is asserting vague or subjective standards to compel interviews or records. “If you get into one of these issues, always try to reach an accommodation and see if there is some other way to satisfy the investigator’s concern before things get escalated,” he said.

He urges drugmakers to not contact the district or regional office with complaints unless absolutely necessary.

“Investigators are people just like everybody else,” he said. “If you are an employee, you don’t want somebody going over your head to your boss.” Going over the investigator’s head might engender ill will, and companies will have to work with the investigator in the future, he added.

Having prepared policies on how to handle such incidents is also vital. Tyler recommends that companies designate a representative to deal with the investigator who knows the facility’s operations and policies regarding records, photos and all company inspection SOPs. There should be a backup in case the designated representative isn’t there, he said.

Have you ever wanted to take your employees inside an interview with FDA investigators to show them exactly what can go wrong? Now you can with the two-part Surviving an FDA Inspection Interview video presentation.