The scene is becoming increasingly common in the United States: Consumers are replacing a trip to the corner drugstore with a click onto the Internet, where they find hundreds of Websites selling prescription drugs and other health products.
Many of these are lawful enterprises that genuinely offer convenience, privacy, and the safeguards of traditional procedures for prescribing drugs. For the most part, consumers can use these services with the same confidence they have in their neighborhood druggist. In fact, while some are familiar large drugstore chains, many of these legitimate businesses are local "mom and pop" pharmacies, set up to serve their customers electronically.
But consumers must be wary of others who are using the Internet as an outlet for products or practices that are already illegal in the offline world. These so-called "rogue sites" either sell unapproved products, or if they deal in approved ones, they often sidestep established procedures meant to protect consumers. For example, some sites require customers only to fill out a questionnaire before ordering prescription drugs, bypassing any face-to-face interaction with a health professional.
"This practice undermines safeguards of a direct medical supervision and physical evaluation performed by a licensed health professional," says Jeffrey Shuren, M.D., medical officer in the Food and Drug Administration's Office of Policy, Planning and Legislation. "The Internet makes it easy to bypass this safety net."
Skirting the system this way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs. "Websites that prescribe based on a questionnaire raise additional health concerns," says Shuren. "Patients risk obtaining an inappropriate medication and may sacrifice the opportunity for a correct diagnosis or the identification of a contraindication to the drug."
To date, FDA has received only a few reports of adverse events related to Internet drug sales, but some of these cases point out the potential danger of buying prescription drugs on the basis of just a questionnaire. For example, a 52-year-old Illinois man with episodes of chest pain and a family history of heart disease died of a heart attack last March after buying the impotence drug Viagra (sildenafil citrate) from an online source that required only answers to a questionnaire to qualify for the prescription. Though there is no proof linking the man's death to the drug, FDA officials say that a traditional doctor-patient relationship, along with a physical examination, may have uncovered any health problems such as heart disease and could have ensured that proper treatments were prescribed.
FDA is investigating numerous pharmaceutical Websites suspected of breaking the law and plans to take legal action if appropriate. The agency has made Internet surveillance an enforcement priority, targeting unapproved new drugs, health fraud, and prescription drugs sold without a valid prescription.
More and more consumers are using the Internet for health reasons. According to the market research firm Cyber Dialogue Inc., health concerns are the sixth most common reason people go online. Internet drugstores, however, won't make "brick and mortar" pharmacies obsolete anytime soon. Industry figures predicted that 2.97 billion prescriptions would be dispensed in 1999, and though no reliable figures gauging total online sales are yet available, industry sources say that number is likely still fairly small.
For some people, buying prescription drugs online offers advantages not available from a local drugstore, including:
Internet drug shopping also purports to save consumers money. In some cases this is true. A survey last fall by Consumer Reports showed that buyers could save as much as 29 percent by obtaining certain drugs online. But another study, conducted in 1999 by the University of Pennsylvania and published in the Annals of Internal Medicine, tracked Internet sales of Viagra and Propecia and found that the two drugs were an average of 10 percent more expensive online than at local Philadelphia-area pharmacies.
In another part of that study, researchers Bernard Bloom, Ph.D., and Ronald Iannocone found that 37 of the 46 sites they examined required a prescription from a personal physician or offered to prescribe a medication based solely on a questionnaire. But nine sites, all based outside the United States, did not require a prescription. The researchers also found that even when Websites offered a questionnaire with the promise that a physician would review the form, nothing was generally known about the doctor's qualifications, and it was easy for users to provide false information to obtain a prescription.
Consumers seeking health products online can find dozens of sites that FDA officials say are legally questionable. A number of them specialize in providing drugs such as Viagra, the baldness therapy Propecia (finasteride), or the weight-loss treatment Xenical (orlistat). Others, based in foreign countries, promise to deliver prescription drugs at a much cheaper price than their domestic cost, but the drugs may be different from those approved in the United States or may be past their expiration dates. Still other sites make fraudulent health claims or blatantly advertise that a customer can buy drugs with no prescription. Online drug sites can now be located in nearly any state or country having phone lines.
Some feel new laws will be needed to improve this situation. "Currently, there is nothing to require a drug-dispensing Website to disclose anything to the public," says Rep. Ron Klink (D-Pa.), who is sponsoring Internet pharmacy legislation. "Buyers have no way of knowing whether a site is licensed or if the site uses licensed doctors or pharmacists or even in what state they are located." Klink's bill would require Internet-based pharmacies to list the name, address and phone number of the principal place of business, the name of each pharmacist and health professional who provides medical consultation, and the states where the pharmacy, pharmacists, and other health professionals are licensed.
Certain pharmacy industry representatives oppose legislation or additional powers for regulatory agencies on the premise that current laws are sufficient to address the problem. "There are [controls] already in place for regulating pharmaceutical sales," says Mary Ann Wagner, vice president of pharmacy regulatory affairs for the National Association of Chain Drug Stores. "That hasn't changed."
Whether new legislation will improve oversight of online pharmacies remains to be seen. For the moment, regulators have entered what FDA's Shuren calls "a whole new ball game" that cuts across the limited jurisdictions of several federal and state agencies. State medical boards regulate medical practice, while state pharmacy boards oversee pharmacy practice. FDA and the Federal Trade Commission ensure that drug sellers make legal claims for their products. Numerous other agencies such as the U.S. Customs Service and the U.S. Postal Service enforce laws regarding the shipment of drug products.
FDA regulates the safety, effectiveness and manufacturing of pharmaceutical drugs, as well as a part of the prescribing process. "It is a violation of the Food, Drug, and Cosmetic Act to sell a prescription drug without a valid prescription," says Shuren. "Therefore, FDA can take action against sites that bypass this requirement." He adds that the advantage of FDA being involved is that states have difficulty enforcing their laws across state boundaries. If one state successfully shuts down an illegal Website within its borders, the site theoretically still has 49 other potential locales in which to sell. However, if the federal government shuts down an illegal Website, that operation is out of business.
Last July, FDA announced that it was joining forces with state regulatory agencies and law enforcement groups to combat illegal domestic sales of prescription drugs. The agency signed agreements with the National Association of Boards of Pharmacy and the Federation of State Medical Boards representing the commitment of these organizations to help enforce federal and state laws against unlawful Internet sellers and prescribers of drugs in the United States.
Though regulating Internet sales of health products is still fairly new, FDA has successfully taken action in the past against illegal sites. For example, a California company called Lei-Home Access Care in 1996 and 1997 used the Internet to sell a home kit advertised as a blood test for the AIDS virus. Not only was the kit unapproved, but the maker also fabricated test results to users who submitted a drop of blood. After an extensive FDA investigation, the site was shut down, and its operator, Lawrence Greene, was sentenced to more than five years in prison.
Last July, the Federal Trade Commission announced a program called "Operation Cure.All," which aims to stop bogus Internet claims for products and treatments touted as cures for various diseases. Over two years, the program identified about 800 sites and numerous Usenet newsgroups containing questionable promotions.
"Miracle cures, once thought to be laughed out of existence, have found a new medium," says Jodie Bernstein, director of FTC's Bureau of Consumer Protection. "Consumers now spend millions on unproven, deceptively marketed products on the Web."
As part of the program, four companies settled FTC charges of deceptive health claims. These included sites that claimed to cure arthritis with a fatty acid derived from beef tallow, to treat cancer and AIDS with a Peruvian plant derivative, and to treat cancer and high blood pressure with magnetic devices. FDA is working closely with FTC on "Operation Cure.All" and has taken its own regulatory actions, such as sending warning letters to help ensure that false and misleading statements are removed from the Internet.
More than a dozen states also have taken some kind of action against Internet pharmacies, including Kansas, which last year prohibited several pharmacies from operating illegal Web-based businesses within the state.
At the same time that regulatory agencies are stepping up enforcement efforts against illegal online drug sales, professional organizations are launching programs with the goal of cleaning house from within. Late last year, the National Association of Boards of Pharmacy (NABP) unveiled its Verified Internet Pharmacy Practice Sites (VIPPS) program, which provides consumers valuable information about the credentials of online pharmacies.
VIPPS is a voluntary certification program. The fairly rigid conditions the online pharmacy must agree to for acceptance into the program include:
VIPPS officials say the program is especially beneficial to seniors. "There is particular concern among the elderly population, which is often the target of unscrupulous marketing ploys," says Kevin Kinkade, NABP executive committee chairman. "VIPPS will be of tremendous benefit to consumers who need to be certain that the prescription medications they receive are from legitimate online pharmacies." At press time, three businesses had been awarded VIPPS certification: drugstore.com, Merck-Medco Rx Services, and PlanetRx.com.
At its June 1999 annual meeting, the American Medical Association drafted guidelines for doctors that specifically address Internet prescriptions. Though these voluntary principles weren't finalized at press time, AMA officials say they are geared to ensure that doctors who prescribe over the Internet follow minimum standards of care. This includes actually examining patients to determine a diagnosis or ensure that a medical problem really exists.
Many in the pharmaceutical industry back the AMA's action. "The relationship between physician and patient is critically important, " says Martin Hirsch, public affairs director for Roche Laboratories Inc., maker of Xenical. "We support guidelines that will ensure that this relationship continues."
With regulatory and voluntary actions in full swing, it still will be hard to stay on top of illegal Internet drug sales. "Even if the state boards, FDA, and others do their jobs, consumers are going to need to be educated about the issue," says Wagner of the National Association of Chain Drug Stores.
FDA plans to help increase public awareness with an education campaign that informs consumers about the health, economic and legal risks of online sales of medical products. The campaign also will target health-care practitioners and industry. Other federal and private groups are conducting similar outreach.
"Consumers need to know the risks of buying prescription drugs online so they can remain vigilant," says FDA's Shuren, " The public also needs to know," he adds, "that there's a price to pay for operating an illegal Internet pharmacy. Even bringing a few highly publicized cases into the public eye will send a powerful message that these illegal sites will not be tolerated."
John Henkel is a staff writer for FDA Consumer.
How Online Sales WorkIn general, legitimate online pharmacies operate this way:
What Consumers Can DoWith hundreds of drug-dispensing Websites in business, how can consumers tell which sites are legitimate ones, especially when it is very easy to set up a site that is very professional looking and promises deep discounts or a minimum of hassles?
"Consumers need to be cautious," says Jeffrey Shuren, M.D., medical officer in FDA's Office of Policy, Planning and Legislation. "You should use the same kind of common sense you use when buying from any business. You look for a reputable dealer. You get recommendations from friends. You check the place out."
FDA offers these tips to consumers who buy health products online:
If you suspect a site is illegal, you can report it to FDA by sending an e-mail to firstname.lastname@example.org.