By T. J. Dunn, Jr., DVM
It was one of those situations I dread. I had just examined Fritzie and spent quite a bit of time making a diagnosis and suggesting treatment for the little Schnauzer’s heart problem. My receptionist buzzed me on the intercom … "Mrs. Smith is still here and wants to talk to you about her bill. She’s certain that you made a mistake and overcharged her for the medication you dispensed for Fritzie. I tried to explain that the $57 was the correct price for the two-month supply but she's certain that’s not right. Good luck!"
After about twenty minutes trying to explain why many of today’s state of the art medications are expensive and that I am not in collusion with the drug companies to soak the general public and that I have an obligation to prescribe whatever medication I believe will be best for my patients, Mrs. Smith and I resumed our day.
It made me uneasy, though, because I wondered how many other Mrs. Smiths were out there who did not call or question me when taken by surprise at the cost of their pet’s medication.
I resolved to provide each client with a handout to accompany every prescription dispensed. It will explain why some medications are so expensive. At least it would save me some stress, and at best it would inform pet owners about the expense pharmaceutical manufacturers must go through to get a drug to market.
And so I did … and now you have the opportunity to read it.
Getting a Medication on the Shelf
Just like any other business, drug companies must make a return on their investment (Read: make a profit) in their products, otherwise they cease to exist. If innovative, safe and effective medications are no longer available for our animals and for us, then the goal of quality of life and freedom from disease will remain out of reach and exist as mere fantasy.
Nearly 300 drugs are currently approved by the FDA (Food and Drug Administration) for use in companion animals (dogs, cats, and horses). Many of these consist of the same active ingredient found in their human drug counterparts; and all must go through the same safety and efficacy procedures designated by the FDA.
The process of getting a chemical from the discovery stage to a saleable product is a long, governmentally regulated, financially draining, scientifically exact, and statistically verifiable process. All major drug companies employ experts in a wide field of science and technology, accounting and finance. Biochemists, veterinarians, physicians, statisticians, accountants and lawyers all must play a coordinated and dedicated role in putting that final product on the veterinarian’s shelf.
It is commonly estimated that when companies do mass screenings of chemicals for potential use as a medication, only one in one thousand will show any promise at all. And if one hundred of these promising chemicals are tested further, only a single one would pass all the criteria required by a company to target it for production.
Let’s say a pharmaceutical manufacturer does decide that a chemical has potential use, what then? The company submits an application to the Food and Drug Administration's Center for Veterinary Medicine, the organization within FDA that approves drugs designed for animals. The process of approval of a substance for licensing is highly regulated. Any animal drug must pass the same SAFETY and EFFICACY protocols that a product for human use must pass.
In the case of animal drug testing the number of individuals used in clinical trial testing is not as large as for products intended for human use. But the same rules and regulations and background verifications must be documented before a new animal or human drug is submitted to the FDA for approval.