The Center for Responsible Science (CRS) is pressing the U.S. Food and Drug Administration to upgrade its informed consent regulations to mention animal testing on drugs. The current FDA system fails to mention animal testing and the extent of how safe the animal-tested drug is for humans.
“It is a regrettably common occurrence that new products on the market contain hidden dangers that the public is unaware of,” commented Megan McBride an attorney with the Levin, Papantonio law firm who practices in the areas of personal injury and product liability litigation.
CRS argued in a citizen’s petition that while animal testing models are “the gold standard during pre-clinical testing,” drugs that appeared safe in those preliminary animal trials “have resulted in severe adverse reactions and deaths when given to humans.” The CRS correctly believes that the FDA’s current, lazy system gives big pharma a pass in introducing potentially dangerous drug to the consumer market.
The non-profit has a pretty strong argument against the FDA in pushing the government entity into revising and updating its informed consent regulations. In 2004, the FDA released a report indicating that most drugs that successfully passed pre-clinical animal testing failed human clinical trials. According to the report, “tools used to assess product safety – animal toxicology and outcomes from human studies . . . have largely not benefited from recent gains in scientific knowledge.”
As the CRS has noted, this practice is a severe ethics violation. The FDA is clearing the sale of drugs that were not only tested on animals in the first place, but also have inconsistent results when applied to human subjects. Now, will the FDA comply with the CRS? That’s uncertain. However, this practice is wrong and should be further surfaced to the public for reevaluation.
When the FDA itself notes that “currently available animal models, used for evaluation potential therapies prior to human clinical trials, have limited predictive value in many disease states,” it’s a wonder why the agency wouldn’t want to reevaluate and upgrade the practice.