Drugmaker challenges FDA on animal testing – By Alex Gangitano (The Hill) / June 27 2019
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 attracted the attention of animal rights activists and lawmakers, putting 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, 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 told The Hill.
“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 told The Hill 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, told The Hill. 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 before 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.
“We’re concerned that it does not inform safety and, at the same time, jeopardizes the life of a number of animals,” Polymeropoulos said.
The FDA has made offsetting animal testing with newer technologies a significant goal, said former Commissioner Scott Gottlieb, who left his post in April.
“The slowness isn’t the policy and the regulation, it’s the science,” Gottlieb told The Hill.
But he added that “things need to evolve” and that the agency needs to find alternate ways to test drugs that “provide the same insurance of safety for products.”
Animal rights groups, who have long sought to reduce or eliminate animal tests, have backed Vanda.
“We’ve often heard behind the scenes that companies are being asked for data using animals. That doesn’t necessarily make sense,” said Kathleen Conlee, the Humane Society’s vice president of animal research issues. She said in most cases, companies fall to pressure “to just do the test to move the product along.”
Conlee said she has not seen another company publicly take a stand in her 20 years working on animal testing issues.
Both Vanda and animal rights groups are pressuring Congress to act on animal testing.
Conlee said lawmakers can provide funding for new technologies to move away from animal testing, which the Humane Society hopes to eventually eliminate.
“I’m not saying all animal testing should end tomorrow. We certainly recognize advancements have been made using animals, but we should all be investing more in replacement of animals,” Conlee said.
Polymeropoulos said he wants Congress to pressure the FDA to better justify such studies. And lawmakers are taking notice.
“I think that one of the ways you can actually judge a society is the way it treats its animals,” said Rep. Brendan Boyle (D-Pa.).
The congressman said ending animal testing is a bipartisan issue and is optimistic Congress can act on it.
Boyle and fellow Rep. Jackie Walorski (R-Ind.) are already taking steps to ensure the welfare of lab animals. They introduced legislation in May that would direct government agencies to develop a policy allowing for animals no longer needed for research in federal labs to be adopted or moved.
The controversy has pulled Vanda and the FDA into a complicated legal fight in the U.S. District Court for D.C. before Judge John Bates, a George W. Bush appointee.
When Vanda asked for a waiver of the dog study, the FDA dismissed the waiver and placed them on a clinical hold in December. Vanda then filed a complaint in February challenging the FDA.
Currently, a new round of testing is on hold. The court allowed the FDA to review its decision and Vanda filed an amended complaint at the end of May.
The case is being closely watched by activist groups and other drug companies.
“Finally, a pharmaceutical company has stood up to the FDA and said, you know, ‘This is not right. This is not scientific,’ ” said Jarrod Bailey, a fellow of the Oxford Centre for Animal Ethics.
The FDA solicited comments last year, under Gottlieb, to find new methods for drug toxicology studies. And in September, the agency is hosting a public workshop to highlight its work.
“[It is] aimed at trying to look at how you can advance things … that could help offset animal testing or help be an adjunct to it. It’s a goal,” Gottlieb said.
Elizabeth Baker, pharmaceutical policy program director at the Physicians Committee for Responsible Medicine, said that FDA stakeholders are “really coming together and saying, ‘We’ve got to do things differently if we indeed want to end up with safer medicines that will work more effectively to treat human disease.’ ”
Baker is hopeful Vanda is bringing change.
“I think it depends also on what happens with the FDA. If it doesn’t end up working out well for Vanda, then maybe companies will not feel as comfortable to take a lead here,” she said.
Bailey said it was unclear if other companies would join Vanda in challenging the FDA on animal testing.
“Certainly, there is increasing resolve within the industry to do this. Let’s not pretend it’s not about money because largely it is,” he said.
But Bailey added, “Vanda should be congratulated for digging their heels in and trying to make this evidence based.”
Polymeropoulos said he recognizes that it’s a difficult decision for other companies.
“To recognize the problem, you need to be close to the problem. Vanda is in a unique position. I’m a founder and CEO, I’m a scientist myself, and I do care about these issues,” he said.
Polymeropoulos said the company is motivated by his original goal.
“Vanda is committed to do the right science for patients, use new technologies and deliver safe drugs,” he said.
https://thehill.com/regulation/court-battles/450551-drugmaker-challenges-fda-on-animal-testing
