A pharmaceutical company is challenging the Federal Drug Administration (FDA) for requiring animal testing of a new drug in a high-stakes lawsuit.
The case has garnered the attention of animal rights activists and lawmakers and put a new spotlight on the agency’s guidelines on animal tests.
Vanda Pharmaceuticals, a Washington, D.C.-based company, was told by the FDA to conduct a nine-month study on dogs of their new drug tradipitant. It will be used as a treatment for gastroparesis, a stomach disorder affecting mostly women that can cause death.
The company conducted a clinical trial of the drug on 150 human volunteers for up to three months and asked the FDA in 2018 for permission to continue the study for longer.
“That’s the start of the problem,” Vanda CEO Mihael Polymeropoulos said to the press.
“The FDA explicitly told us — based on a guidance, which is a recommendation, not binding — that in order to expose patients to more than three months treatment, certain studies have to be done,” he said. “We’ve done most of them except one: a dog study where you treat dogs for nine months. Then you sacrifice the dogs and you look at their organs.”
The company says it asked the FDA to justify the need for the study and that the agency did not. It then filed suit to continue testing on humans.
The FDA said that it does not comment on pending litigation.
For Vanda, the stakes are high. Since the start of 2019, its stock has gone down nearly 50 percent, from $27 a share to just over $14 today.
“Vanda is making an ethically admirable decision and is the kind of company that deserves our respect,” said Sahar Akhtar, a visiting professor at Georgetown University on ethics and business. But Akhtar also acknowledged that “animal tests are costly. Vanda might be doing what’s in the strategic long-term interest of the company as well.”
Vanda has conducted animal studies previously and believes there is a place for such experiments, but the company didn’t believe a nine-month dog study was justified for a drug they had already studied in humans for up to three months.