March 15, 2002

 

 Internet pharmacies and compounding are high-priority areas, FDA says - March 15, 2002

Posted on March 1, 2002

 

Since prior coverage on the issue of Internet pharmacies (see JAVMA, June 1, 2001, and Aug. 15, 2001), the AVMA continues to receive complaints and queries on the subject. With the development of the AVMA Pharmacy Complaint Form, more than 125 veterinarians have copied the AVMA on their comments to the Food and Drug Administration, boards of pharmacy, and boards of veterinary medicine.

Sample complaints against Internet pharmacies include the sale of prescription medication directly to consumers without a veterinarian-client-patient relationship, and some pharmacies operating within the United States selling products that come from countries that may not have the same kinds of quality and purity assurance the United States does. It is generally illegal to dispense foreign drugs in the United States, including foreign versions of U.S. products.

Compounding pharmacies, some of them Internet based, pose a twofold concern. The first involves the selling of compounded drugs directly to consumers rather than on the prescription of a veterinarian. The second concern is using bulk drug chemicals to prepare imitations of approved drugs.

The AVMA has been communicating to the FDA its concerns regarding illegal pharmacy practices that undermine the veterinarian-client-patient relationship and are contrary to best patient care. Dr. Steven F. Sundlof, director of the FDA Center for Veterinary Medicine, acknowledged that fact, saying, "The AVMA has been providing us with information they've been receiving on Internet pharmacies."

Dr. Sundlof said that the FDA-CVM has targeted the issues as high priority for investigation and enforcement. In January, the FDA announced that it began an investigation of Internet and compounding pharmacies and their compliance with regulations for prescription products.

"We will be sending people out into the field to try and make purchases; we will develop our own chain of evidence," Dr. Sundlof said. "We'll be working with the state boards of pharmacy in order to supplement where our jurisdiction ends and their jurisdiction can take over. We will probably be doing some surprise inspections, and if we find that the companies are in violation of any of our regulations, we will follow up with enforcement action."

Dr. Sundlof explained the nature of the investigations. "We will be looking at the firms that seem to have the most egregious practices—ones that are, for instance, coercing veterinarians to prescribe drugs, or [are] just prescribing them outside the veterinarian.

 

"These Internet pharmacies are appearing all over the place. They seem to be undergoing a fairly steep growth, and more and more, they are selling directly to consumers [without a prescription]."
Dr. Stephen F. Sundlof

 

"If we find they're importing drugs, then we'll have to stop that, because that is a practice where they need FDA's permission if they're going to import drugs from other countries."

According to Dr. Sundlof, among the challenges involved in regulating Internet sites are that, once they're shut down, they can appear under another name, and that at the moment, there are plenty of sites doing plenty of business.

"These Internet pharmacies are appearing all over the place," he said. "They seem to be undergoing a fairly steep growth, and more and more, they are selling directly to consumers [without a prescription]. We're aware of one operation that reported over $7 million in profits last quarter."

Relative to the compounding pharmacies, Dr. Sundlof noted that, in addition to the agency's food safety and animal safety concerns, "[Compounding pharmacies] undermine the legitimate companies that have gone through the approval process."

The FDA has a whole range of enforcement tools it can bring to bear against enterprises operating illegitimately, Dr. Sundlof said, beginning with warning letters and following up to make sure there is subsequent compliance with the Food, Drug, and Cosmetic Act. "If that is unsuccessful, we can go to other things, like seizure and enjoining the firms from continuing to do business. We can work through the court system to actually prosecute individuals and levy fines against them."

The AVMA is not a regulatory agency but is facilitating the reporting of firsthand complaints and is pleased with the regulatory attention. Prescription drugs are regulated by federal and state agencies. The FDA can take action if prescription drugs are sold without a valid prescription. The state boards of pharmacy regulate the practice of pharmacy in the state in which the Internet pharmacy is located and in states where consumers receive prescription drugs. The state boards of veterinary medicine regulate the practice of veterinary medicine, including the authorizing of prescription drugs by veterinarians without a veterinarian-client-patient relationship. The AVMA has been communicating its concerns to state regulatory authorities.

In addition to creating the Pharmacy Complaint Form, the AVMA has compiled a list of frequently asked questions, reported on rogue pharmacy activity, and approved a position statement that encourages veterinarians to honor client requests to prescribe rather than dispense a drug when a valid veterinarian-client-patient relationship exists and the drug is medically indicated. AVMA members can access information on "Addressing prescribing and dispensing in your practice" through the Resources tab at www.avma.org.

The Executive Board authorized the Prescribing and Dispensing Subcommittee of the AVMA Council on Biologic and Therapeutic Agents to meet March 3 and assemble representatives of pharmacy organizations along with state and federal regulators to further open lines of communication and heighten awareness of the issues and concerns related to appropriate prescribing and dispensing.

The AVMA encourages veterinarians who have had some experience with rogue pharmacies to use the AVMA Pharmacy Complaint Form, accessible on page 729 and the AVMA Web site. FDA-CVM Compliance Officer Sue Williams reminds veterinarians to provide as much information as possible on the forms, as they have received some forms submitted with missing state references and contact information.

Dr. Sundlof wants veterinarians to be aware that some Internet pharmacies are operating appropriately. "We recognize that there are some legitimate firms, so we're trying to make sure that we don't interfere with...their ability to...work through veterinarians in providing the clients with the needed drugs at a fair market price."

For more information, call Dr. Elizabeth Curry-Galvin, assistant director of the AVMA Scientific Activities Division, at (800) 248-2862, ext. 290, or Sue Williams of the FDA-CVM at (301) 827-0155.