February 2017
On the Edge of Common Sense

A Journey to the FDA

I have never seen the Taj Mahal, the Vatican or Fort Knox, all monoliths wrapped in mystery, placed beyond politics, Google and the Rubix Cube. But I can now claim I have seen the FDA in the Land of Acronyms, Washington D.C., and survived. In my case, it was the FDA CVM ... Food and Drug Administration Center for Veterinary Medicine. 

I was escorted by my friend, Dr. Jim, DVM, CEO, president and founder of SVC, a company that consults and guides pharmaceutical companies through the maze required to earn drug approval for use in animals. The mental picture I had before my visit was akin to the Supreme Court or a court-martial ... a line of wizened, beady-eyed, scowling geezers wearing robes and wigs looking down at the poor supplicant who is trying to present his case while strapped to a wooden chair with duct tape under a swinging interrogation lamp.

I WAS WRONG!

Ten of the most influential people in the world of veterinary drugs invited me to join them at a conference table that appeared to be borrowed from a high school teacher’s lounge. Two were wearing jeans, three wore a tie and all were wearing comfortable shoes. The attire was casual.

Each one took the time to explain their position and responsibility including livestock, equine, dogs, cats, minor species, legality, finance, practicality and impact. The subject on top of their pile is the possible resistance of organisms to antibiotics passed from animal to man. To date, there is no proof that it happens, but others think it might. It’s like the cause of global warming. Tough decisions.

To appreciate the scope of their job, imagine a list of all veterinary drugs in use from 1965 through today that have been approved by CVM. The process of approval is detailed and time-consuming. Their mission statement reads, "Protecting Human and Animal Health." They ensure the drug is safe and effective for the patient, and, in food animals, safe for people to eat. Talk about all-consuming! That is a huge promise. But they keep it and don’t back down. There are no loopholes. Rarely do we see such rock-solid commitment to the people’s benefit, especially from government. It is the gold seal, the guarantee, the third-party verification; it’s the law. Until CVM was instituted, medicine was CAVEAT EMPTOR, let the buyer beware. And that same warning exists today on drugs for animals and humans without the FDA CVM seal of approval. Just read the label on the back.

Being able to talk to those brilliant, dedicated people at that table helped me to realize they can see into the future of medicine. Genes loom large.

Hearing them talk amidst themselves was mesmerizing, sort of a cross between ESPN sports announcers and J. Robert Oppenheimer in Los Alamos speculating with his crew about their next atomic bomb.

It takes awhile for their profound contribution of protecting human and animal health to sink in. Think about it. The least I could do was to offer to buy’em lunch. They graciously declined.

 

Baxter Black is a former large animal veterinarian who can be followed nationwide through this column, National Public Radio, public appearances, television, and also through his books, cds, videos and website, www.baxterblack.com.