Penny-wise owners can be pound foolish, drugmakers say.
Animal owners who question a drug’s price often don’t understand the time, the scientific breakthroughs and the regulatory hurdles involved in bringing a product to market, manufacturers say.
“Issues of cost are very real,” says Dana Fertig, DVM, MS, manager of veterinary technical services at Dechra Pharmaceuticals PPC, a British firm with U.S. headquarters in Kansas City, Mo.
“The issue of price questioning is where having a trusting relationship with clients can make all the difference. If owners trust that what the veterinarian is recommending is best for their pets, they’re more likely to comply with recommendations. Using something proven to work on the condition means a speedier recovery.”
But what clients need to understand most, manufacturers say, is that Food and Drug Administration approval of a drug means the product is efficacious.
Luitpold Pharmaceuticals of Shirley, N.Y., is committed to strict adherence to FDA rules and regulations, says Allyn Mann, product manager for Luitpold’s Animal Health Division.
“We maintain very high-quality standards for our manufacturing to ensure the ongoing safety, efficacy and concentration of active ingredients that is required for FDA approval. The results and the costs involved should be valued by veterinarians since this helps them have confidence in their prescribed treatments,” Mann explains.
“Without FDA approval on products, they have no guarantee of the product’s safety, efficacy or concentration because it has not been through the FDA approval process, nor has the product, its components or its production been subject to FDA inspection. This is very important for veterinarians’ clients to understand,” Mann says.
Manufacturers seeking FDA approval face a lengthy, rigorous process that includes establishing a protocol, setting criteria and recruiting veterinarians and owners willing to participate in a drug trial. Once the trial is complete, the compiled data is presented to the FDA.
“When going through the required steps, you have to think about the time frame to have the drug on the market in years, not months,” Dr. Fertig says. “After all the data is gathered, there’s still no guarantee the product will be approved. If you want the drug to be approved for another species, the process starts all over again, testing it on a new set of animals.”
Conducting a trial can be complicated. Manufacturers say data gathered from a pet cannot be used if the owner doesn’t follow the protocol, administers medication incorrectly or drops out.
“You need 50 to 200 animals per trial. The more animals participating, the better the end statistics will be,” Fertig says. “Keep in mind that some of the diseases being looked at for the trial aren’t always commonly diagnosed, so it can take a long time just to get enough animals to participate in the trial.”
And that’s just the beginning.
“The FDA is keenly interested in the manufacturing process, the consistency from batch to batch, quality-assurance and quality-control procedures, the purity and potency of product produced, shelf life, the development of an assay to do these test procedures,” Fertig says.
“All of this has to pass FDA approval. So, the product itself is only part of the entire FDA approval process. In addition, any literature associated with the product must pass approval. This involves client brochures and technical literature that the company representatives use when visiting clinics.”
Many therapies used in place of more expensive proven treatments are supported only by anecdotal evidence of efficacy and safety, says Natasha Mahanes, a spokeswoman for Merial Ltd. of Duluth, Ga.
“Clinical trials, if any, used to support their claims often do not meet regulatory standards,” Mahanes says. “Additionally, there are many conditions for which effective alternative therapies do not exist—for example, heartworm preventives—but for which approved and proven products are available from veterinarians.”
The average cost of acquiring FDA approval of a new animal drug is $100 million and takes seven years. But a company’s involvement with a drug doesn’t end with the approval. A company must continuously submit information to the FDA.
“The cost of maintaining FDA approval is going up,” says Ron Phillips, vice president of legislative and public affairs at the Animal Health Institute in Washington, D.C. “Annual reports, adverse-event data and inspections account for some of the ongoing expenses with keeping an FDA drug on the market.
“Owners and even some veterinarians don’t know that the standard for animal drugs, meaning tests and trials, are the same as those required of human drugs.”
The Animal Health Institute represents 15 licensed member companies and nine affiliate members that have an invested interest in animal health. U.S. government agencies involved in the approval and regulatory process of the members’ products include the FDA for pharmaceuticals, the Department of Agriculture for biologics and the Environmental Protection Agency for pesticides.
Merial, for one, provides product expertise and support to veterinarians and their staffs through technical services departments, Mahanes says.
When Owners Say No
Veterinarians are animal advocates first and penny pinchers for clients second. Despite a veterinarian’s best efforts, however, a client’s protest of a drug’s price tag can win out and a less favorable, second-treatment plan goes into play. This may mean running fewer tests and prescribing a medication that does not have FDA approval.
“Some drugs are life sustaining, such as cardiovascular drugs, hormone therapies, anti-parasitics and antibiotics,” says Nancy Bathurst, VMD, clinical development manager at Virbac Corp. of Fort Worth, Texas. “Other drugs improve the quality of life, such as pain medications, dermatologic drugs and dietary supplements. But all drugs should render some kind of beneficial effect while posing minimal risk to the end user.
“Many [secondary] therapies have not been studied for efficacy in any kind of scientific manner. They have undetermined safety profiles and there is very little oversight of these products during their field use.
“In essence, the users are essentially testing the products on their own pets with the results never being collected,” Dr. Bat-hurst says. “It seems to be a high price to pay, risking the health of a pet who the owner felt was worth bringing to the vet in the first place on an unproven treatment that at best may work in some and at worst may harm some.”
A drug that has gone through the regulatory process has essentially undergone “risk mitigation,” Bathurst says. This process costs a lot of money that is spent not only by the manufacturer but by the authorizing administration as well.
Because costs are passed to the consumer, the pet owner essentially is “paying for the privilege of using a product that has been thoroughly evaluated for its efficacy and safety,” Bathurst says.
“Within that system there are also stopgaps or measures for detecting problems with the product that may not have been apparent during the pre-approval studies,” she says. “This is called pharmacovigilence.
“This process is mandated by the FDA and requires that drug manufacturers monitor the field use of their drugs and report any adverse events that occur during that use. This further protects the consumer by helping the FDA and drug manufacturers to identify and resolve any issues through updated product labels containing cautions and warnings, recalls and product improvements.
“All of this is a very expensive undertaking and can result in the cost of a veterinary drug being viewed as high by the pet-owning public.”
Veterinarians typically mark up drugs 60 to 100 percent from what they paid—depending on the product, the socioeconomic status of the clientele and how frequently the drug is used. By the time the client buys the drug, the cost has gone up multiple times.
“Many factors are evaluated when determining the price of a product, including the cost of raw materials, cost of manufacturing and of course the significant cost of the research and development necessary to bring a product to market,” Mahanes says. “Merial does not have a manufacturer’s suggested retail price for products, and we do not track the average retail price of products sold through veterinarians. Veterinarians who sell the products determine the retail price at their sole discretion.”
Manufacturers say explaining to clients how drugs are priced can improve compliance. Alternatively, suggesting pet health insurance may prevent drug price discussions.
“If pet health insurance catches on more in the U.S., owners focusing on cost before efficacy could be significantly reduced,” Fertig says. “The FDA is there to ensure any drug they approve is safe and efficacious.
“It sounds simple, but it’s extremely important. Dechra has about 1,000 products that are FDA approved, so we have some experience with this.”