Circumventing the #USDA
Entest BioMedical, a small biotech in San Diego, is taking an interesting approach to testing their newest canine cancer vaccine. Rather than going through the normal channels for animal drugs (USDA/FDA), they are buying up local animal hospitals in hopes of using the therapy without national approval. They have plans to acquire 10 local hospitals, which should provide the company with enough cash and patients to continue testing their innovative oral melanoma treatment.
The company does plan to make the drug available worldwide at some point, but they want to delay the regulatory process (and the $50 million price tag) until they have more data available. Due to a USDA loophole, the treatment can be used in hospitals owned by the company without approval. There seems to be no stipulation about purchasing hospitals to grow the patient base, so in the short-term, their plan seems to have merit.
This is technically a legal move, but is it an ethical one? Owners of pets who are involved in the study must pay for the treatment themselves, and the referral process may be biased, since the vets who suggest the treatment will be directly profiting from it as major stockholders in Entest.
Personally, I wouldn’t feel comfortable dosing my dog with unregulated drugs, and I would definitely oppose having to pay for for medicine with such limited testing. Entest’s business model is not very repeatable, so there is little worry of more animal treatments slipping through the regulatory cracks.
Learn about regulation for animal health products at the World Animal Health Congress.