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New Danger in Delay: FDA Guidance Merits Review of Internal Procedures for Facility Inspections

November 21, 2014

Recent Happenings in APRM
November 2014

The Federal Food, Drug, and Cosmetic Act (FDCA) authorizes the U.S. Food and Drug Administration (FDA) to inspect facilities that manufacture and store drugs. FDCA § 704. "Refusal to permit entry or inspection" by FDA investigators is, of course, a "prohibited act" under FDCA § 301, and, in theory at least, is punishable with monetary fines and criminal sentences. FDCA § 303.

In 2012, the FDA Safety and Innovation Act (FDASIA) introduced a more practical tool for enforcing the agency's inspection authority against drug manufacturers. It allows FDA to take action against a specific product by deeming a drug "adulterated" if it "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection." FDCA § 501(j) (emphasis added). With this added tool, FDA may take quick action against products made by drug manufacturers that unreasonably delay or obstruct FDA investigators.

This past October, FDA published Guidance giving examples of behavior that would constitute delay, denial, or limitation under § 501(j), as well as circumstances that would warrant "reasonable" explanation for such actions by facilities. The Guidance carefully couches its descriptions in the language of "reasonable" or "unreasonable," giving FDA ample flexibility when it comes to enforcement, but suggesting that the agency is seeking simply to be met with common sense and practical cooperation during inspections.

For example, the Guidance states that not allowing an FDA investigator to access an area without a reasonable explanation would constitute unreasonable delay. However, refusing access until the investigator accommodates the facility's documented gowning procedures would be a reasonable delay. Similarly, the Guidance states that rejecting FDA's attempt to schedule an inspection, or falsely stating that a facility does not manufacture or hold drugs, would be unreasonable denials of access. If, however, an FDA investigator arrives unannounced and the facility is closed due to scheduled maintenance, it is not unreasonable to deny access. 

Notably, the Guidance states that impeding or resisting photography by an FDA investigator may be considered an unreasonable limitation.  Although FDA has always maintained its authority to take photographs during inspections, the FDCA does not specifically mention photography. The Guidance formally asserts that power, but explains that limitation of photography could be deemed reasonable if "the chemical properties of products manufactured at the facility are such that taking photographs would adversely affect product quality."

The newly published Guidance does not substantively alter FDA's inspection authority. The scope of establishment inspections is still defined by Section 704, which was not amended. What is new, however, are the tools FDA has available to enforce its inspection authority:  branding products adulterated if a drug manufacturer impedes, delays or limits inspection by FDA representatives. Although FDA previously had to seek court orders to compel inspections, it can now detain or seize product that becomes adulterated through delay, denial or limitation of its inspection authority, and it could even enjoin facilities that routinely frustrate agency inspections.

This new enforcement option dramatically increases the risk of perceived impediments or noncompliance when FDA investigators inspect facilities. Though "reasonable" behavior is easy to expect in the abstract, unannounced visits by FDA investigators can cause confusion or nervousness among facility staff and representatives. If staff members present during an inspection are not adequately prepared, confusion or hesitation during an inspection may be perceived as delay or denial of an investigator's "reasonable" request. In light of the new Guidance, any such inadvertent conflict during an FDA inspection now risks causing a manufacturer's product to be deemed adulterated. 

Drug manufacturers should act now to ensure readiness for inspections, including review of internal practices and procedures governing outside inspections. In particular, companies should review practices prohibiting or limiting photography during an inspection, and evaluate whether the restriction is necessary. Further, companies should proactively train and prepare staff and representatives to receive and handle FDA investigators, and ensure that inspection requests are accommodated without unreasonable delay.  More than ever, it will be vital for facility representatives to effectively and clearly communicate with FDA investigators to identify and explain grounds for any denial or limitation of the inspection.

It is prudent to conduct an anticipatory review of your facility's inspection procedures and training of facility staff. Such preparation can ensure continued compliance with the FDCA, and a smooth transition as FDA investigators may be more willing to exercise this recently clarified authority.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910