FDA Doesn’t Seem To Care That Novartis Still Sells Antibiotic As Pig-Fattener

The website for Novartis antibiotic feed-additive Denagard has an entire page dedicated to the drug’s growth-promotion effects.

Last week, we told you how pharma biggie Novartis was still openly marketing at least one of its antibiotics as a growth-promoter for livestock, even though the FDA had politely asked drug companies to pretty please stop selling antibiotics for non-medical uses. Given the voluntary nature of this guidance, not to mention its numerous loopholes, it shouldn’t surprise anyone that both the FDA and Novartis shrugged off critics’ concerns.

An estimated 80% of antibiotics sold in the U.S. go to livestock farmers, mostly because the drugs have the happy side effect of promoting growth in these animals. They also have the unhappy consequence of encouraging the development of medicine-resistant bacteria, making those same drugs less useful in the long run.

The FDA guidance was intended to curb this overuse of antibiotics in animal feed by asking pharmaceutical companies to only sell the drugs for treatment and prevention of disease. And yet, right there on the website for Novartis’ swine antibiotic Denagard is an entire page touting the drug’s growth-promotion results. Since being an average size pig is not a disease, this would seem to violate the spirit of the guidance, as it gives livestock farmers a non-medical reason to purchase Denagard and claim that it’s for a non-existent or exaggerated medical purpose.

That was the gist of the letter written to the FDA last week by the group Keep Antibiotics Working.

“Many of the drugs approved for production uses like growth promotion also have approvals for disease prevention and control and can be administered in essentially the same manner as for growth promotion (i.e. no requirement for diagnosis, herd or flock wide use, and unlimited duration),” wrote KAW’s Steven Roach. “Companies that persuade animal producers of the production benefits of the use of these drugs can expect more use over longer periods of time in greater numbers of animals — in short, higher sales.”

The FDA has responded to the KAW letter, and it doesn’t provide much in the way of hope for people hoping the agency was serious about cutting down on medically unnecessary antibiotics.

“In your letter, you express concern that drug manufacturers may promote extralabel production uses for products approved only for therapeutic use, thereby undermining the spirit and intent of [the guidance], reads the letter. “We understand your concern and, as part of the… implementation process, we intend to look for ways to reinforce the importance of the principles of judicious and appropriate use, including engaging animal drug manufacturers on the appropriate use of promotional materials.”

To us, this statement comes across as more derriere-dragging from an agency that waited for more than three decades to issue antibiotics guidance it was told to draft back in the 1970s — and only did so after being sued for its inaction.

The FDA says it will “look for ways to reinforce the importance of the principles of judicious and appropriate use,” which seems to indicate it intends to come to a compromise with an industry that denies — in spite of all the research to the contrary — that there is any link between overuse of antibiotics and drug-resistant pathogens.

Speaking of which, Novartis eventually got around to responding to our request for a statement and issued the following comment which denies that growth-promotion is an off-label use of Denagard, and passes the buck back to the FDA:

“Novartis Animal Health US, Inc. does not promote off-label uses of Denagard, or any of its products. The US Denagard website clearly explains that Denagard is used therapeutically, and that the animal performance benefits derived from use of Denagard result from a reduction in disease associated with stressful periods that are directly related to higher disease levels throughout a pig herd.

The US Food & Drug Administration (FDA) not only protects public health by assuring the safety, efficacy and security of human and veterinary drugs, but the agency also reviews promotional materials, including websites. The content in the website referenced by the group Keep Antibiotics Working (KAW) in their letter to FDA was submitted to FDA at the time of its development as required by the agency’s regulations. NAH is committed to advertising and promoting its products according to the labeled claims.”

Yes, the Denagard site does explain that the drug has therapeutic uses. But this statement implies that the “animal performance benefits” touted on the site are solely from disease prevention. Then why does the site have an entire page dedicated to growth-promotion? And why does that page tell farmers about their “return on investment” in terms of how many pounds of the antibiotic they need to feed their pigs versus weight gain in those animals? We would consider that an “animal performance benefit” that has nothing to do with treating or preventing disease.

Then it points the blame arrow at the FDA, saying the agency approved the site so there can’t be anything wrong with it. Just because the FDA approved the site doesn’t mean that Novartis can’t remove the growth-promotion page. Novartis could have opted to remove this obvious promotion of a non-medical use for Denagard, but instead chooses to keep it up because it knows this is a selling point for the drug.

“Why should FDA bother asking companies to remove growth claims from their labels if they are going to allow them to promote therapeutic drugs based on their growth promoting benefits?” KAW’s Roach tells Consumerist in response to the Novartis statement.

KAW tells Consumerist that the group plans on meeting with the FDA to discuss the Denagard website and the issue of off-label promotion of antibiotics.

“We hope they will commit to challenging companies that are promoting the production benefits of drugs without promotion approvals, but that will not address the broader problem of FDA’s failure to prohibit the routine use of medically important antibiotics for disease prevention.”

Congresswoman Louise Slaughter of New York has been an outspoken critic of the FDA’s guidance on antibiotics, which she says is “riddled with loopholes and completely inadequate” to fight the spread of drug-resistant bacteria. Rep. Slaughter says that without mandatory limits on antibiotic use, the overuse of these drugs will continue.

“When a company is offered the choice to comply with a regulation or work around it, it’s not surprising when the company chooses the most financially attractive option – more often than not, that option is noncompliance,” she explained in a recent statement.

by Chris Morran via Consumerist