HP&M-Authored WLF Legal Backgrounder Provides “Warning Letter” to Industry Regarding FDA’s Inspection Practices

March 16, 2015

In a new Legal Backgrounder published by the Washington Legal Foundation, Hyman, Phelps & McNamara, P.C.’s James P. Ellison, Anne K. Walsh, and Andrew J. Hull* write a “Warning Letter” to FDA-regulated drug establishments regarding FDA’s inspection practices.  We have written on FDA’s inspection authority in the past (see here and here), and this article addresses FDA’s aggressive position on that inspection authority. 

FDA’s position was most recently set forth in FDA’s Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (2014), published to interpret section 707 of the 2012 Food and Drug Administration Safety and Innovation Act (“FDASIA”).  This section states that a drug stored in an FDA-regulated facility is deemed adulterated under the Federal Food, Drug, and Cosmetic Act (“FDCA”) when the facility “delays, denies, or limits an inspection, or refuses to permit entry or inspection.”  As such, FDA’s interpretation of its lawful inspection activities could have draconian effects on those who are unprepared for the positions that FDA may assert during an inspection.

For instance, the authors analyze the agency’s questionable position that facilities must allow FDA inspectors to take photographs as part of an inspection.  The authors argue that this and other FDA inspection practices may well fall outside the inspection authority granted to FDA by Congress.

The authors conclude the article by writing:

Because of unresolved questions regarding FDA’s inspection authority and aggressive inspection practices, a company must be aware of the agency’s expectations during an inspection.  Without forethought and internal policies in place specifically contemplating the issues discussed in [the article], a company runs the risk of being caught off-guard by an inspector’s requests and possibly providing FDA with evidence beyond FDA’s inspection authority.  A company could be handing FDA evidence and information to which it would not otherwise be entitled, absent a subpoena, warrant, or other lawful process. 

* Admitted only in Virginia.  Work supervised by the Firm while D.C. application pending.

Categories: Enforcement