Lawyers question legality of US FDA final guidance on delaying, denying inspections

By Zachary Brennan contact

- Last updated on GMT

Lawyers question legality of FDA final guidance on inspections

Related tags: Law

What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance, “critically vague and legally questionable in several ways.”

Jay Cormier and Anne Walsh of the law firm Hyman, Phelps & McNamara said the final guidance​ goes further than the draft in its claim that “impeding or resisting photography​” may limit a manufacturing facility’s investigation and that such a conclusion “is in the discretion of the investigator​.” 

FDA’s only example of a ‘reasonable explanation’ for not allowing photos during an inspection borders on ludicrous:  FDA claims it would be reasonable to not allow photos if the light from a camera flash could adversely affect product quality.  As we discussed​ in depth when the Draft Guidance was issued, the issue of FDA’s authority in the realm of photographs is murky, at best​,” the lawyers write.

Drug manufacturers also previously took issue with the draft guidance​, seeking clarity on when a manufacturer’s actions could be used against it.

The final guidance “also signals FDA’s view that an inspector has the authority to ask questions of, and demand oral answers from, any individual at a facility – particularly if the individual is designated as a subject matter expert… Given that FDA has no statutory authority to require anyone ​to answer any questions during an inspection, FDA’s example seems either (1) naïve with respect to the statute, or (2) foundation for a later FDA argument that failure to provide individuals who can ‘accurately answer the FDA investigator’s questions’ is itself a ground for a violation​,” the lawyers note.

Language Shift

The lawyers also point out that the FDA shifted its language from “adequate​” to “reasonable​” in defining types of justification necessary for a delay, denial, limit or refusal to be excused.

The term ‘adequate’ seemed to render FDA the ultimate finder of fact – whether the facility’s reason for a delay is ‘adequate’ to excuse the delay is something that appears to be clearly a discretionary…One may be tempted, therefore, to take refuge in the softer tone of ‘reasonable,’ particularly if that person has spent time in or around a courtroom or law office where the term ‘reasonable’ has a very specific and long-established meaning,” ​the lawyers write.

They also contend that the final guidance “unfortunately, creates issues rather than clarifies issues. Whether FDA will ‘get away’ with the regulatory creep evidenced in the Final Guidance will depend on facilities holding FDA accountable to the four corners of the FDCA and not ceding ground to FDA​.” 

What’s clear, however, is that the final guidance should be a reminder for companies to utilize written internal procedures that address inspections, “such as whether and who, if anyone, is authorized to speak to FDA during an inspection and the company’s position regarding the taking of photographs and providing documents that are off-site​,” the lawyers say.

Related topics: Markets & Regulations, QA/QC, Regulations

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