also contributed by Alexis Kellert
In a draft guidance document issued recently, the FDA identified four non-exclusive categories of prohibited behavior that the agency considers to constitute “delaying, denying, limiting or refusing a drug inspection.” In particular, the new guidance expands the FDA’s power to photograph during inspections and characterizes attempts to limit photography as a prohibited behavior. Section 707 of the Food and Drug Administration Safety and Innovation Act (“FDASIA”), Pub. L. 112-144, provides the FDA discretion to deem any drug adulterated that was “manufactured, processed, packed, or held in any factory, warehouse, or establishment” where an employee engaged in a prohibited behavior to obstruct inspection. Thus, the issue of inspection photography is likely to take on greater significance as the FDA moves towards including photography as a standard rather than discretionary component of facility inspections.
The FDA has long asserted that it has authority, under Section 704 of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 374, to take pictures during on-site inspections of drug facilities. When challenged on the issue, the FDA cites to two decisions for legal support. See Dow Chemical Co. v. United States, 476 U.S. 227 (1986) (holding that Environmental Protection Agency (“EPA”) had statutory authority to use aerial photography during a site inspection of a chemical company’s industrial complex); United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa, 1976) (holding that photographing warehouse conditions by FDA agents was not unreasonable). Neither case, however, directly addresses the scope of FDA authority to take photographs during an in-plant inspection.
In Acri Wholesale Grocery Co. the agency’s right to take pictures inside a grocery warehouse was sustained, but there, the ruling focused on the company’s failure to object in a timely manner and not whether the FDA was empowered to take photographs. Similarly, defense attorneys have long distinguished Dow Chemical from the issue of the FDA’s power to photograph during drug facility inspections because (1) Dow Chemical involved aerial photographs taken of the outer façade of the facility only; and (2) the EPA—not an FDA agent—photographed the site. Thus, no court has ruled on the targeted issue of whether Section 704 provides the agency with a legal right to take photographs during in-plant inspections.
Despite the absence of case law directly supporting the FDA’s position, its updated Investigations Operations Manual (“IOM”) instructs inspectors not to request permission to take photographs and encourages them instead to assert their right to take photographs. See Section 126.96.36.199 (emphasis added).
Under the new guidance, any attempt by a company manager or employee to limit, or outright prohibit, photography during inspection will constitute an unacceptable obstruction resulting in detention of products and potential prevention of sale of any drugs seized by the FDA. As Law360 recently reported, the FDA’s proposed examples of prohibited behavior often hinge on whether “reasonable explanations” or “adequate justifications” exist to explain the limitations imposed on inspectors attempting to photograph the inspection site. Notably, the agency has not defined these terms.
Perhaps most worrisome for manufacturers is the potential inconsistency of enforcement among inspectors that will result from the ambiguous draft language. In a similar vein, industry leaders worry that as production activities are moved abroad cultural misunderstandings may leave foreign manufacturers unprepared and ill-equipped for American regulators’ inspection expectations.
The new guidance may be driven by the fact that photographic evidence can be very persuasive — a picture is worth a thousand words after all. In fact, the guidance openly explains, “photographs are an integral part of an FDA inspection because they present an accurate picture of facility conditions.” Section V(B). Similarly, the IOM instructs its field personnel that “since photographs are one of the most effective and useful forms of evidence, every one should be taken with a purpose.” See IOM 5.3.4. The implication of photographs depicting product storage conditions, visible contamination of raw materials or substandard maintenance of equipment for litigation is that it may effectively foreclose potential—and commonly used—arguments that the FDA is exaggerating the conditions.
One approach regulated industries should consider is taking their own photographs contemporaneously with FDA inspections. A company’s “selfie” may help to combat or limit mischaracterizations of facility conditions and to undermine the evidentiary significance of FDA photographs used at trial. They may also help provide context for what is taking place by giving a broader view. Companies may obtain copies of any photographs taken from the FDA as requests fall within the terms of the Freedom of Information Act. See IOM 188.8.131.52.
Companies may also attempt to claim that the areas of the facility sought to be photographed contain trade secrets or other proprietary business information that should not be subject to photography. It is no guarantee that such a claim would prevent the photographs under the new guidelines, but to have any chance of success the claim would be bolstered if these areas were previously identified in company procedures and guidelines as being confidential or “off limits” to photography so as not to appear as merely an ad hoc contention of confidentiality.
Only time will tell how the new guidelines will play in the real world, but regulated companies should be ready for their close-up and prepare accordingly.
Editor’s note: Alexis Kellert is a summer associate at Weil.