Animal & Veterinary
On-Line Internet Sales of Animal Drugs: Good or Bad?
by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No II
No one would disagree that the Internet has changed our lives in countless ways. For many of us, it has become our primary means of research, communication, learning the news, and even shopping. What could be easier than the press of button to bring the world to our fingertips? Through secure Web sites, we freely offer up our e-mail address, personal information, and even our credit card numbers to make a purchase. Clearly, the Internet has become for many Americans the fastest, easiest, and most convenient way to shop, eliminating the need to get in a car, fight traffic, find a parking place, and sift through racks of merchandise only to find the product you want is out of stock.
Purchasing medications on line has become extremely popular in recent years. But along with the convenience, the anonymity, and the ability to shop in the privacy of our own home comes the need for care and attention to the pitfalls of on-line shopping, especially for something that affects our—or our pet’s— health. Purchasing approved drugs online through legitimate pharmacy sites on the Internet provides consumers with a convenient way to obtain needed medications for Fido, Fifie, and Flopsy, sometimes at more affordable prices. Many reputable Internet pharmacies allow pet owners to consult with a licensed pharmacist from the privacy of their home, and some of these pharmacies can provide customers with written product information.
Valid prescription required
However, a number of problems with some Internet pharmacies have been reported, such as sales of veterinary prescription medications without valid prescriptions; such sales are illegal and violate Section 512 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as well as 21 Code of Federal Regulations Section 530. These Federal sanctions require that a licensed veterinarian authorize a prescription only pursuant to a “valid veterinarian-client-patient relationship.” More importantly, animal drugs sold without a valid prescription could pose a health threat to pets and other animals. Unfortunately, the Internet makes it easy for unscrupulous people to sell human and animal drugs to consumers without Federal safeguards in place. A Web site may appear to be associated with a legitimate pharmacy, when in fact it is not. Web sites that sell prescription drugs without a valid prescription deny pet owners the protection provided by an examination conducted by a licensed veterinarian.
The National Association of Boards of Pharmacy has identified approximately 200 domestic Web sites that dispense prescription drugs but do not offer an online prescribing serv-ice whereby a prescription would first have to be mailed or FAXed. However, many of the Web sites that do offer both prescription drugs and a prescribing service are located in foreign countries (e.g., Namibia, Sri Lanka, and Thailand), and these pose a major problem for the Food and Drug Administration because it is so hard for the agency to control these overseas operations. Such “rogue” Internet sites think nothing of using deceptive practices to lure purchasers, and they can literally be in business today, close down tomorrow, and reopen the next day in a new location.
So, how does a pet owner identify a quality, legitimate Internet pharmacy? Admittedly, there really is no fool-proof way to ensure such an operation. But the National Association of Boards of Pharmacy has created a voluntary pharmacy certification program called VIPPS (Verified Internet Pharmacy Practice Sites) to help consumers evaluate Internet pharmacies. The VIPPS seal of approval identifies those online pharmacies that are appropriately licensed and prepared to practice pharmacy via the Internet, and that have successfully completed a rigorous criteria review and inspection. Pet owners who experience problems with any online pharmacy should report the pharmacy to the Board of Pharmacy in their home State as well as the pharmacy’s State, if it is different. Naturally, any adverse reactions suffered by a pet or other animal should be reported to either the veterinary drug sponsor or FDA (1-888-FDA-VETS).
On-going Federal efforts
FDA works closely with the States to determine the validity of online prescriptions and to bring enforcement actions under State law, Federal law, or both, as appropriate. FDA has worked with trade associations and the Association of Attorneys General to establish points of contact in all of the States specifically for Internet-related problems. Several States have taken or are thinking about taking action against illegitimate online sellers of prescription drugs. Fourteen States (Arizona, California, Colorado, Connecticut, Illinois, Michigan, Kansas, Nevada, New Jersey, Ohio, Texas, Washington, Wisconsin, and Wyoming) have already taken some action against physicians prescribing drugs over the Internet. Most of these cases involve cease and desist orders, but some States have imposed fines and are contemplating stiffer penalties.
Pet owners and all consumers need to understand that it is illegal for anyone, including a foreign pharmacy, to ship drugs that are not approved by FDA into the United States, even though the drug may be legal to sell in that pharmacy’s country. The FFDCA requires all drugs—including animal drugs—to be proven safe and effective before marketing in this country. U.S. law also requires that products approved for sale in the United States have their formulation approved by FDA, be made in a plant that is registered with FDA, and be produced under quality standards enforced by FDA.
The following categories of products cannot be legally sold in the United States:
- prescription drugs available from a foreign pharmacy that are products not approved by FDA;
- products with similar, but not identical formulations as FDA-approved products;
- products not made under the quality standards required by U.S. law or labeled according to U.S. requirements; and
- products not stored or distributed under the quality conditions required in the United States.
Reporting unlawful sales on the internet
Consumers who believe they have encountered a Web site that is illegally selling any medical products over the World Wide Web are encouraged to select one of the three options below to report to FDA.
If the report:
- involves a life-threatening situation due to an FDA-regulated product you purchased from a Web site, call 1-866-300-4374 or 301-796-8240 immediately. (Also contact your health professional/veterinarian for medical advice.)
- involves a serious reaction or problem with an FDA-regulated product, fill out FDA’s MedWatch reporting form. (Also contact your health professional/veterinarian for medical advice.)
- involves a problem Web site that does not involve a life-threatening or otherwise serious reaction, fill out the online form located on FDA’s Web site at http://www.fda.gov/oc/buyonline/buyonlineform.htm. To report e- mails promoting medical products that you think might be illegal, forward the email to email@example.com.
Caution always urged
The agency cautions pet owners who want to buy their pet’s medication over the Internet to proceed cautiously, to talk with their veterinarian, and to insist on the same quality expected from a veterinary clinic or pharmacy. Fido, Fifie, and Flopsy deserve nothing less.