Dear Valued Client,
Recent developments in the pharmaceutical world have set up conditions where the cost of treatment for canine hypothyroidism, levothyroxine, will increase.
For a long time, various manufacturers of levothyroxine sold their product without any regulatory oversight. These manufacturers reverse-engineered their product from the patented levothyroxine on the human market. The Food and Drug Administration (FDA) turned a blind eye, recognizing the need for a treatment of canine hypothyroidism that was proving to be effective.
The law clearly states that no drug may be sold without appropriate manufacturing practices and without showing “substantial evidence” of safety and effectiveness. The FDA can’t force a manufacturer into compliance short of shutting down their operations. The FDA could have told all manufacturers of levothyroxine in the canine space to cease production, and they would have had legal ground to do so because this production of levothyroxine was technically illegal. Shutting down production, though, was not in the interest of animal health, and as a result, the FDA exercised “regulatory discretion.”
This has now changed. Lloyd’s recently invested in the necessary research and demonstrated substantial evidence of safety and effectiveness of their product and a consistent, appropriate manufacturing process. Because Lloyd’s has gone through the FDA’s approval process, it now has exclusivity on the market and unapproved products can no longer continue production. This law of exclusivity enables companies to recoup their investment in the approval process, and it is what facilitates the research and development of new, helpful drugs and treatments. Lloyd’s will hold this patent exclusively for a number of years.
Manufacturers of the unapproved versions of levothyroxine have been ordered to cease production, and they have until July to sell their stock. We do not know what the cost will be once Lloyd’s has a monopoly. We also do not know when this monopoly will effectively take place, as this depends upon how quickly the unapproved manufacturers deplete their stocks. In the meantime, we at the Cuyahoga Falls Veterinary Clinic have purchased a large supply of various sizes of levothyroxine in an attempt to keep costs down for our clients for as long as possible.
Unrealistic expectations are the quickest route to disappointment. At some point in the very near future, the cost of treatment for hypothyroidism will increase, and please understand that this cost increase is both necessary and out of our control.