Just the review process -- where the company works with the FDA to meet requirements for proper design of the safety and efficacy studies -- may take years to complete. And the time a pharmaceutical manufacturer takes to get a product to market (usually more than five years for a canine product) has a huge impact on how long it will take for the company to make a return on its investment.
A good example is provided by Ann Jernigan, Head, Pharmaceutical Discovery Group at Pfizer Animal Health, Groton, CT. She states that the innovative topically applied parasite control medication called Revolution was nearly ten years in the discovery process. Literally thousands of products were screened before Revolution’s active ingredient, called Selemectin, was selected for development. Jernigan indicates that several millions of dollars are commonly spent on the development of animal health drugs and hundreds of millions on human medication development.
Robert Livingston, DVM, of the Animal Health Institute which represents manufacturers of medications for farm and companion animals, states "Even if everything goes well in the review and testing process, it often takes longer than five years to get a canine drug on the veterinarian’s shelf. It is extremely costly and time consuming to get the required numbers of actual cases of treated and untreated control animals for the necessary studies."
He goes on to say that "Drugs intended for use in animals often require an investment of $20-100 million, while for human drugs the cost can reach $500 million or more before any actual sales of the drug are permitted."
And even after a medication becomes available, post marketing safety evaluation for adverse effects goes on for the life of the medication.
Finally, after going through all the research, development, clinical trials and FDA review, a company has only a limited period of time remaining on their patent protection to recoup their investment. It really makes no sense to produce something and sell it at a price that allows you to regain the investment it took to make it, only to have another company copy it and sell it at a lower price.
The copycat company has no research and development costs, no clinical trials to perform or document, no new product marketing to do. Therefore, the price the manufacturer sets for a drug reflects the need for the manufacturer to get a return on that huge expense of time and effort to obtain a license to sell the product.
Making a profit is a necessary factor in the whole equation. If the drug company does not make a profit sufficient to cover all costs of research, development, production and marketing, there will be no state-of-the-art medication for your dog’s medical problem. If the veterinarian does not make a profit from dispensing the medication (or the pharmacy a profit if you obtain a prescription and get it filled at some other source), there will be no animal hospital or pharmacy for you to rely on for help when your pet is in need.
Well, that’s my handout for anyone who wants to know why Fritzie’s heart medication costs so much. And you read it first right here! Obtaining a diagnosis is the first part of a successful trip to a doctor’s office. The second part is acquiring the proper medication or treatment protocol to alleviate the ailment that was diagnosed.
Today’s dogs have a distinct advantage over their ancestors of just a few years ago. But safe and effective medications do come at a cost -- a cost that most dog owners are more than happy to pay if the medications improve the quality of life for our canine friends.
Image: Erich Ferdinand / via Flickr