In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans,  Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s Center for Drug Evaluation and Research issued a Warning Letter to a drug company for improper drug listing information.¹

Highlights

• FDA wrote that the company provided an incorrect active ingredient (conjugated estrogens vs. esterified estrogens) when it submitted its electronic listing file.
• The agency noted it sent the company two letters, one about the listing errors and another about removing the products from FDA’s Online NDC Directory.
• FDA stated, “Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety.”
• As is common practice with Warning Letters, the company must respond within 15 working days or face an increased enforcement risk.

AGG Observations

• FDA cares about the little things. We do not mean to suggest that listing deficiencies are “little,” but we typically see the issuance of Warning Letters for quality-related concerns, promotional deficiencies, regulatory classifications matters, or public health risks. This issue here was an administrative, submission error.
• The previous (failed) attempts by FDA to have the company voluntarily comply did not help. Don’t ignore FDA.
• The type of product at issue could have been of particular concern to FDA but improper listing, regardless of the product, is unlawful.
• As noted, this type of Warning Letter is not typical. However, it shows FDA will enforce this type of unlawful activity by issuing a public letter, and it reminds industry that, at times, it pays to sweat the small stuff.

[1] See www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eci-pharmaceuticals-llc-625254-02032022.