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The AVMA Council on Biologic and Therapeutic Agents held an informal meeting in Philadelphia on July 25 with representatives from several veterinary associations and the Food and Drug Administration to discuss the issues surrounding illegal drug compounding from bulk substances and how to address them. Several of the groups attending have already begun efforts to educate their members and curb illegal drug compounding, but they decided that, in addition to those efforts, it is important for veterinary organizations to collaborate to educate veterinarians.
The controversy surrounding veterinary drug compounding from bulk substances began heating up when the FDA published a revised Compliance Policy Guide on veterinary drug compounding in July 2003 (see page 804). Since then, the FDA has been aggressive in its enforcement of the drug compounding laws. The department has issued several warnings to veterinarians and compounding pharmacies. The renewed focus on drug compounding has brought to light the fact that many veterinarians are confused about what constitutes illegal drug compounding.
It is illegal, for example, for compounding pharmacies to circumvent the FDA's drug approval process and compound drugs from bulk ingredients; it is illegal for compounding pharmacies to use bulk drug substances to produce mimics of existing FDA-approved products, or to manufacture and distribute drugs in bulk quantities.
While the CPG is a perfect fit for food animal medicine, said the incoming chair of COBTA, Dr. Gatz Riddell, the council recognizes that there may be circumstances in other areas of practice when it may be necessary to compound from bulk ingredients to produce a medically necessary product—that is not otherwise available—for a specific patient. To ensure that the FDA is aware of these needs, COBTA has sent a letter to the FDA encouraging it to amend the CPG. And COBTA continues to discuss the issue with the FDA.
"It's apparent that [the FDA doesn't] want to restrict the use of medically necessary products," Dr. Riddell said. "They want to stop the illegal manufacturing, they want to stop counterfeiters, and they want to stop products that mimic FDA-approved products and subvert the FDA-approval process."
There are a lot of potential problems with illegally compounded veterinary drugs, according to the meeting attendees. For instance, there is 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.
"There's a lot out there that's sold, and not a lot that's very effective," said Dr. Lionel L. Reilly, a member of COBTA. "We just don't know."
Also, if compounding pharmacies are producing drugs that mimic FDA-approved products, and marketing them to veterinarians as a cheaper version of the same thing, Dr. Riddell said, it creates a disincentive for drug companies to spend money on research and development.
Dr. Riddell said that veterinarians are creating a market for these products.
"A little bit comes back to us as a profession and how we handle this, and how we educate our members. It wouldn't be an issue unless some in our profession are driving it," he said. "It's a failure of education."
The meeting attendees agreed that it is essential to educate veterinarians about their legal and ethical responsibilities with regard to using compounded drugs, and to ensure they are savvy enough to ask the right questions before buying compounded drugs.
"The most important thing is educating veterinarians, and training them that it's unethical to use some of these products," said Dr. Joe Bertone, a COBTA member.
Dr. Dennis Feinberg, the president of the American Animal Hospital Association, said practitioners also need more clarification from the FDA.
"I think we need a clarification, and we need a proactive education effort," Dr. Feinberg said.
Dr. Neal Bataller, an FDA veterinarian and regulatory policy analyst, said the FDA is willing to aid educational efforts, and FDA employees would be willing to speak to veterinary groups about these issues.
"We want to educate [veterinarians] effectively," Dr. Bataller said. "I think we do need to work together to educate veterinarians."
Some educational efforts have already begun. The AVMA, the American Association of Bovine Practitioners, the American Association of Equine Practitioners, and the American Association of Swine Veterinarians have taken a stance on illegal drug compounding. The AVMA's Council on Biologic and Therapeutic Agents has established a subcommittee on compounding, and has contributed to JAVMA News articles on the subject. The AABP has banned businesses or organizations that produce, advertise, promote, or sell products compounded from bulk drugs for use in food animals from exhibiting or advertising at the AABP convention or in any AABP publication. Dr. Tom Burkgren, the executive director of the AASV, has said practitioners should follow the Animal Medicinal Drug Use Clarification Act, and that the AASV would decline advertisements or exhibits from businesses that illegally compound drugs. The AAEP recently established a task force to address illegal drug compounding; see article below.
Now, meeting attendees say, it's time to work together and send out a unified educational message to veterinarians.
"We have an obligation to correct this in our profession," Dr. Feinberg said.
AAEP task force to tackle illegal compounding
In response to growing concerns about illegal drug compounding in the animal health industry, the American Association of Equine Practitioners has assembled a task force to educate its members about the ethical and legal issues surrounding drug compounding.
Over the past several months, the AAEP has been aggressive in its efforts to educate its members about drug compounding, publishing several newsletter articles and offering educational sessions and panel discussions at the AAEP's convention. Now, the AAEP has created the task force to establish a clear set of guidelines. Dr. James P. Morehead, who has been tapped to chair the AAEP's compounding task force, said these steps were necessary and urgent because too much illegal compounding was taking place, and too few veterinarians were educated about it.
"It was out of control," Dr. Morehead said. "The Compliance Policy Guide has many gray areas in it, and many compounding pharmacies were taking advantage (of veterinarians' confusion)."
Dr. Morehead said most veterinarians are unwilling to push the limit and do something illegal. But if they are not educated about what constitutes illegal compounding, they may fall prey to salespeople who promise cost savings on compounded drugs.
The AAEP guidelines will attempt to explain what constitutes illegal compounding. The task force also will educate the AAEP's membership about the potential animal health risks associated with the use of compounded products. Because compounded products do not go through approval by the Food and Drug Administration, their safety, efficacy, and even their concentrations may be questionable.
In addition to educating members, the AAEP has been discussing compounding issues with the FDA and AVMA. In fact, the AAEP invited officials from the FDA to attend the AAEP's convention sessions on compounding, and welcomed Dr. Elizabeth Curry-Galvin, an assistant director of the AVMA Scientific Activities Division, to serve on the AAEP compounding task force.
The AAEP also is requiring all compounding pharmacies that wish to exhibit at the AAEP convention to sign a compliance form stating that they are in compliance with the government regulations on drug compounding.
Dr. Morehead said cooperation between veterinary organizations is essential to solving this problem.
"If all veterinary organizations educate their members and address FDA compliance with compounding pharmacies exhibiting at their meetings, I think it will be a self-correcting problem," Dr. Morehead said. "But first, you have to educate veterinarians ... and they will do what's right."