US regulators, and in particular the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), are regularly in the practice of sending out "Untitled Letters"--admonishments of a practice (or practices) of a company that does not quite meet the threshold needed for a Warning Letter. In almost all cases, these letters are sent with respect to the promotion of a human drug product. But as one Untitled Letter sent on 2 August 2013 illustrates, FDA doesn't just pay attention to human products.
A Rare Letter
The letter in question was sent by FDA's Center for Veterinary Medicine (CVM) to ECO Animal Health, the holder of New Animal Drug Application (NADA) #141-336), Aivlosin Water Soluble Granules (tylvalosin as tylvalosin tartrate). Aivlosin is a macrolide antibiotic intended to control porcine proliferate enteropathy (PPE) in groups of swine where an outbreak has occurred.
According to FDA, ECO had been promoting its Aivlosin product using several different materials, including on a website, using a product profile, an information brochure and several technical briefs regarding proper use of the product.
FDA's letter to ECO, authored by CVM's Division of Surveillance, states that the claims are "misleading because they contain incomplete and inadequate information about the approved indication for Aivlosin," causing the product to be misbranded under Sections 502(a), 201(n) and 502(n) of the Federal Food, Drug and Cosmetic Act (FD&C Act).
The letter is a rare example of FDA enforcing its antibiotic prescribing guidance document, GFI #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern. The guidance is intended to limit the use of antimicrobial products in instances where their injudicious use could lead to the development of resistance factors in bacteria, posing a heightened risk to human health.
"The guidance categorizes classes of antimicrobial drugs in terms of their importance to human medicine, which serves as one component of a risk estimation that FDA uses to determine whether the drug can be approved with specific management conditions to mitigate the risks of using the drug," FDA explained.
And that's where ECO Animal Health's promotional materials get the drug into trouble, FDA said. The drug was approved with language intended to limit its use exclusively in instances where an outbreak of PPE is already in effect-not to prevent its occurrence.
A 'Truncated Version'
However, ECO's promotional language contains what FDA referred to as a "truncated" version of the approved indication statement, which notes only that the drug is used to "control" PPE, and not exclusively in cases where an outbreak has already occurred.
Because the statement both removed a necessary limitation on the drug's intended indication ("fail to reveal material facts") and failed to present the full indication ("must contain a true statement of information in brief summary relating to the drug's … effectiveness"), FDA said the company had failed to communicate important information, thereby rendering the drug misbranded.
Pressing the point further, FDA noted that unlike similar human Untitled Letters, the omission of information in this case could increase the probability of the PPE-causing bacteria gaining resistance to macrolide antibiotics, which the agency explains is "critically important" to humans.
FDA said ECO must immediately cease dissemination of the faulty promotional labeling and respond to FDA within 30 days.
Untitled Letter to ECO