Correspondence
Direct Sale of Sildenafil (Viagra) to Consumers over the Internet
N Engl J Med 2000; 342:740-742March 9, 2000
- Article
To the Editor:
The article by Armstrong et al. (Oct. 28 issue)1 highlights the use of the Internet to bypass traditional safeguards imposed by Congress and state legislatures to protect patients from dangerous drugs and the improper practice of medicine and pharmacy. As the authors mention, drug sales over the Internet pose challenges for regulatory and law-enforcement bodies at the federal and state levels. The laws in effect today were not enacted with the Internet in mind. Although the practice of medicine and of pharmacy is traditionally regulated by the states, on-line sales of drugs frequently cross state borders, making it difficult for states to bring effective enforcement actions against out-of-state sellers and prescribers. Although the Food and Drug Administration (FDA) does not generally regulate the prescribing of drugs, it does have the authority to take action when a prescription drug is sold without a valid prescription. Such a sale is both a federal and a state violation. The FDA maintains that prescribing a drug for the first time solely on the basis of a questionnaire is, in many cases, also illegal under federal law. Therefore, the FDA believes that the illegal domestic sale of drugs over the Internet can best be addressed through collaborative efforts between the FDA and the states.
The FDA is currently working with several state boards of medicine and pharmacy to investigate the illegal on-line selling and prescribing of prescription drugs. As part of this effort, in July 1999 the FDA signed principles of understanding with the National Association of Boards of Pharmacy and with the Federation of State Medical Boards, representing the commitment of these bodies to enforce federal and state laws against illegal domestic drug sales over the Internet. The FDA, the National Association of Boards of Pharmacy, and the Federation of State Medical Boards are drafting partnership agreements to formalize a process for prosecuting Internet drug cases and for sharing information.
Health care professionals and patients can also help curtail illegal and unethical Internet drug sales. Patients should avoid purchasing from Web sites that will sell a prescription drug without a prescription or that offer to prescribe such a drug for the first time without a physical examination. Physicians and pharmacists should educate their patients about dangerous on-line practices. The FDA also encourages health care professionals and patients to report any suspicious Web sites to the FDA or to the National Association of Boards of Pharmacy. Until fully effective safeguards are in place, patients and health care professionals should be cautious when using or recommending the use of the Internet for the purchase of prescription medications.
1 ReferencesJane E. Henney, M.D.
Jeffrey E. Shuren, M.D., J.D.
Food and Drug Administration, Rockville, MD 208571
Armstrong K ,Schwartz JS ,Asch DA . Direct sale of sildenafil (Viagra) to consumers over the Internet. N Engl J Med 1999;341:1389-1392
Full Text | Web of Science | Medline
To the Editor:
The recent article on the availability of sildenafil on the Internet is accurate as far as it goes (and its conclusions are undeniable). Perhaps because the researchers used only a 10-day sample, however, and were apparently not familiar with the way that this and other “lifestyle drugs” (e.g., orlistat [Xenical], levonorgestrel–ethinyl estradiol [Preven], minoxidil [Rogaine], and finasteride [Propecia]) are marketed on the Internet, they missed an even bigger story. Most of these drugs are not sold by the site owners. The sites the researchers visited were most likely to be “affiliates” of a “spider” linked to the site. These affiliates do not have possession of the product, and the “on-line consultation” offered is really a link to the spider's main consultation page. Thus, the percentages noted in the article are skewed because they do not account for multi-ple hits on the same consultation pages (albeit without the knowledge of the Internet user). Many of these consultation pages are, in turn, linked to offshore physicians who are paid a fee only if they prescribe the drug.
We have identified hundreds of sites offering lifestyle drugs and have concluded that most of them are affiliate sites. There are only a few score spiders on the Internet, but they replicate very quickly by offering commissions to affiliates for each order placed through them. This is even more insidious than the danger addressed by the authors.
Donald E. deKieffer, J.D.
deKieffer & Horgan, Washington, DC 20005Author/Editor Response
The authors reply:
To the Editor: Since the publication of our article on the prescription of sildenafil over the Internet, federal regulatory efforts in this area have increased considerably. The Clinton administration has asked for legislation that would regulate Internet prescription practices by requiring Internet pharmacies to obtain FDA approval, by imposing stiff fines for selling prescription pharmaceuticals without a prescription, and by enlarging the FDA staff devoted to Internet regulation.1 The U.S. Customs Service reports having seized 1.9 million pills from foreign sources in 1999, almost eight times more than in 1998.2 Although consumers may find scores of Internet sites offering pharmaceuticals for sale without a prescription or an examination, deKieffer points out that the regulation process may be able to focus on a limited number of “spider” organizations that provide the actual drugs or physician consultations.
At the same time, Internet-based prescribing and dispensing of pharmaceuticals may offer some important advantages that need to be protected as new regulations are developed. Convenience and perhaps cost reductions may accompany Internet dispensing, and automated, Web-based procedures for Internet prescribing may actually reduce medical errors of other kinds. Internet health care will continue to evolve, and we must recognize that these changes bring both opportunities to preserve as well as dangers to avoid.
2 ReferencesKatrina Armstrong, M.D.
University of Pennsylvania School of Medicine, Philadelphia, PA 19104-6021David A. Asch, M.D.
Philadelphia Veterans Affairs Medical Center, Philadelphia, PA 19104- Citing Articles (1)
Citing Articles
1
C. H. Fung, H. E. Woo, S. M. Asch. (2004) Controversies and Legal Issues of Prescribing and Dispensing Medications Using the Internet. Mayo Clinic Proceedings 79:2, 188-194
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