Quiet on the Set? Forbidding FDA To Take Photographs During An Inspection Can Be Regrettable

A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection.  We haven’t seen an FDA Warning Letter citing a refusal to permit photographs for years, so, just as FDA is apparently reviving these types of allegations, it is probably time for us to revive blogposts that have discussed this issue for more than a decade now.

The current Warning Letter was issued to a drug manufacturer in China (Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.) for multiple violations observed during an inspection that occurred eight months ago.  One of the foremost allegations is that the FDA inspection team attempted to take photos of two filling machines that FDA observed to be “dirty and in an apparent state of disrepair, despite the equipment status being identified as clean.”  Management, according to the Warning Letter, “stated that the investigators were not allowed to take photographs of the equipment as part of the inspection.”  FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.”

To be clear, as we discussed in a blogpost back in 2013, the Federal Food, Drug, and Cosmetic Act does not explicitly require companies to permit photographs to be taken.  Section 704 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. §374(a)(1)(B)) has required, for years, FDA-regulated industry to allow FDA “officers or employees” to “inspect, at reasonable times and within reasonable limits and in a reasonable manner,” any facility and “all pertinent equipment, finished and unfinished materials, containers, and labeling therein.”  FDA has always claimed that this gives them the authority to take photographs while conducting an inspection, as reflected in its Investigations Operations Manual (at Section 5.3.4.1), provided that “photos are an integral part of an inspection.”  The Manual also advises inspectors, if plant management refuses photographs, to cite two cases that the Manual claims authorize the taking of photographs, but those cases, in the view of critics like me, actually only authorize use of photographs in court when the investigated entity has not refused to permit photographs to be taken.

Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is here).  FDASIA authorized FDA, in Section 707(b), to issue a guidance about what constitutes refusing an authorized FDA inspection, which is a crime under Section 301(f) (21 U.S.C. §331(f)).  In addition to the blogpost above, the resulting draft and then finalized Guidance has been the subject of several blogposts on our authoritative blog (authoritative, at least, in our own minds, as to matters of FDA law) and other articles we’ve authored, including here, here, here, here, and here.

Because the Guidance was required to be issued by FDASIA, it may have more compelling effect than most FDA guidances, which explicitly state that they are not binding law.  On the other hand, they may not be any more compelling than other FDA guidances: the U.S. Supreme Court’s Loper Bright decision limits the deference that courts should afford federal agencies in the agency interpretation of what laws mean (see blogposts here, here, and here).

To be sure, this is not the first time that FDA has included the “Limiting Photography” observation in a Warning Letter.  In August 2017, Homeolab USA received a similar observation, although it was the last substantive observation in the letter (in the recently issued Warning Letter, the allegation ranked near the top).  In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.  And for foreign companies, FDA does not even need to go through the formality of issuing a Warning Letter to get its way.  FDA’s standing Import Alert 66-79 includes a long list of companies whose products can be stopped at the border simply because the foreign company tried to limit photography during an FDA inspection, among other things (the Warning Letter that prompted this blogpost included a warning that FDA would “continue” to block imports from the inspected facility for its enumerated violations.  The addition of a company to an import alert is purely administrative, yet it carries an immediate penalty to companies that dare to limit FDA’s inspections.

So, how to proceed?  If you don’t want to face a battle with FDA, keep “quiet on the set,” an obscure reference to a miniseries subtitled “The Dark Side of Kids’ TV,”, and also the phrase directors would supposedly scream after the advent of “talkies.”  Don’t tell Investigators they can’t take pictures.  Ask them why they think they are entitled to take pictures, ensure that what they are photographing is within the scope of their inspection powers, and then take side-by-side photographs so you can demonstrate later if the FDA photos are misleading.

If you want to challenge FDA investigators for being outside of their inspectional authority, prepare to address an observation in a Warning Letter.  Unfortunately, multiple courts have held that Warning Letters are not final agency action, so it may be hard to judicially challenge FDA’s authority to take photographs during an inspection.