Novartis called out for undermining FDA's animal health rules

Antibiotic resistance--which health experts caution has been exacerbated by widespread use of the drugs in animals--has become a hot-button issue as experts link it with the spread of infectious diseases, including MRSA. The FDA responded at the end of last year with revised industry guidelines for animal drugmakers but has had difficulty grabbing the attention of Big Pharma. Novartis ($NVS) is the latest alleged offender, with health advocates going after the Swiss company for its suggestive advertising of one of its pig pills. 

Despite the FDA having made it clear in its new animal health rules that antibiotics cannot be medically unnecessary, these advocates say Novartis barely even bothered to advertise its swine antibiotic Denagard as medically viable. The Swiss drug company instead highlighted weight gain in animals--a purpose not approved by the FDA.

Keep Antibiotics Working filed a complaint letter with the FDA last month claiming that while Denagard is approved for controlling dysentery and treating pneumonia and enteric disease in pigs, the drug's website unabashedly boasted charts and data showing it also fattens them up. "The [advertising] materials tout benefits to performance in terms of daily gain, body weight achieved, feed to gain ration and return on investment, all indicators of productivity not animal health," the letter reads.

This type of marketing, they argue, blatantly undermines the FDA's animal antibiotic resistance policy. They've asked the FDA to step in on Novartis' marketing of the drug, and also send a notice to all drug manufacturers that the agency "will not tolerate the claims of production benefits in advertising associated with any medically important animal antibiotics."

The coalition is chasing Novartis on the heels of a bigger issue: Farmers are giving their animals antibiotics like sweets, recent numbers show. The World Organization for Animal Health (OIE) estimates that 80% of all antibiotics purchased domestically are administered to farm animals. A Department of Agriculture survey says that just shy of half of the country's dairy farmers give their livestock antibiotics without a vet's prescription.

"FDA believes that, in light of the risk that antimicrobial resistance poses to public health, the use of medically important antimicrobial drugs for production purposes in food-producing animals does not represent a judicious use of these drugs," the agency's revised animal health guidance reads.

While Novartis initially denied the coalition's claims last week, telling The Wall Street Journal its advertising materials for the drug "clearly explains that Denagard is used therapeutically," the company has modified its website for Denagard to clarify that any weight gain benefits meant bacteria was under control. A Novartis spokesman later told the WSJ these changes were made in favor of a non-professional audience.

- here's the letter from Keep Antibiotics Working (PDF)
- take a look at the FDA's Guidance for Industry #213 (PDF)
- and here's more from WSJ's Pharmalot blog