FDA targets web sites selling unapproved drug
Virtual pharmacies get warning from the FDA
Although physicians and pharmacists have been concerned for some time about the emergence of "virtual" pharmacies that sell prescription drugs over the Internet, the situation has been made critical by some entrepreneurs’ response to the anthrax attacks.
On Nov. 1, the U.S. Food and Drug Administration (FDA) issued warnings to 11 international Internet vendors who were offering generic ciprofloxacin for sale to American consumers.
"The FDA is unable to determine whether these products were made in accordance with U.S. specifications and, therefore, their sale and distribution in the U.S. may be illegal," reads a statement issued by the administration.
A recent on-line search performed by Medical Ethics Advisor turned up more than 34 hits for sites offering Cipro prescriptions on-line. With names such as "www.2-buy-cipro-online-4-anthrax-bacteria-resistance.com/" and "www.cipro-anthrax-cure.com," many sites require no prior physician’s prescription and offer on-line consultations and approvals. After Nov. 1, many of the sites were no longer accessible or featured revised statements advising consumers to contact their private physician or public health department if they were concerned about anthrax exposure.
According to the FDA announcement, the agency is warning U.S. citizens that foreign drugs promoted on the Internet may not be approved for marketing in this country and may not be legally imported.
The agency is informing regulatory officials in the countries in which the Internet pharmacies operate that these potential violations are taking place, and it is advising the U.S. Customs Service that shipments from these vendors may be detained and refused entry.
In addition to the foreign web sites, some pharmacists are concerned about the proliferation of web sites in this country that offer prescription drugs on line, including sites that "bypass" the need for a doctor’s prescription by providing on-line "consultations," says Carmen Catizone, MS, RPh, executive director of the National Association of Boards of Pharmacy (NABP).
The association is asking consumers to buy only from on-line pharmacies that are approved through its Verified Internet Pharmacy Practice Sites (VIPPS) program.
The VIPPS seal on the pharmacy’s web site certifies that the pharmacy is properly licensed with the appropriate state boards of pharmacy and has met a rigorous criteria review that considers the site’s protection of patient confidentiality, the authenticity and validity of prescriptions, a quality assurance program, and patient-pharmacist consultation. The following on-line pharmacies are VIPPS certified:
• accuratepharmacy.com at www.accuratepharmacy.com;
• Caremark Inc. at www.rxrequest.com;
• Clickpharmacy.com at www.clickpharmacy.com;
• CVS Washington Inc. at www.cvs.com;
• drugstore.com at www.drugstore.com;
• Express Pharmacy Services/Eckerd.com at www.eckerd.com;
• familymeds.com at www.familymeds.com;
• Merck-Medco Managed Care LLC at www.merck-medco.com;
• Savon.com at www.Savon.com;
• Tel-Drug Inc./CIGNA at www.teldrug.com;
• VitaRx.com at www.VitaRx.com;
• Walgreens.com Inc. at www.Walgreens.com.
Even with the program, Catizone remains concerned about the ability to order large quantities of Cipro on line.
"More and more people are using the Internet. If there is a run on Cipro over the Internet and there is a shortage, innocent people could be harmed or killed because other people have stockpiled the medications for themselves," he says.
The NABP has been concerned about stockpiling and on-line orders of prescriptions before, but now the issue is more urgent because people are trying to order large quantities of drugs that are needed to treat life-threatening illnesses, he says.
"We have dealt with it before with the lifestyle’ drugs like Viagra and Propecia. But then, we were worried about individual patients harming themselves and taking medications they maybe should not," he explains. "When you look at it now, if hundreds of people order Cipro on line and deplete the local supply, [and] you or I or our families who need that medication and cannot get it, you are endangering our health."
Although the Atlanta-based Centers for Disease Control and Prevention maintains that it has sufficient antibiotics in its federally authorized pharmaceutical stockpile to provide treatment for anyone exposed to anthrax, stockpiling could still result in distribution worries in the event of a large-scale or multiple-site event, Catizone adds.
Regarding the on-line pharmacies offering generic ciprofloxacin, the FDA warns it is concerned about more than protecting the interests of U.S. pharmaceutical patents. Federal law prohibits the importation of drugs that are not approved in the United States, including foreign versions of U.S.-approved drugs, because they are not subject to FDA evaluation. Drugs ordered via these "rogue" sites could include any of the following:
- The drugs may be contaminated and harmful.
- They could be counterfeit and not contain the advertised drug’s active ingredient.
- They could contain the wrong dose.
- They may not be safe and appropriate for the user (in the absence of screening by a health care professional).
- The consumer may not have access to a health care professional if serious side effects occur.
- The consumer may not receive the product at all after sending payment.