by John Henkel
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 Web sites 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 pharmacist. 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, 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 direct medical supervision and a 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way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs. "Web sites 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, the FDA has received only a few reports of adverse events related to Internet drug sales, but there are potential dangers in buying prescription drugs on the basis of just a questionnaire. Many drugs should not be used in certain people or in combination with certain other drugs, or they require special monitoring. Bypassing the physician can lead to a failure to assure safe use of drugs. 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 in March 1999 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.
The FDA is investigating numerous pharmaceutical Web sites 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.
A Brave New World
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. Over 3 billion prescriptions were dispensed in 2000, 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 compared to purchasing drugs from a local drugstore, including:
- the privacy and convenience of ordering medications from their homes
- greater availability of drugs for shut-in people or those who live far from the pharmacy
- the ease of comparative shopping among many sites to find the best prices
- greater convenience and variety of products
- easier access to written product information and references to other sources than in traditional storefront pharmacies
Internet drug shopping is said to save consumers money. In some cases this is true. A survey in the fall of 1999 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 either 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 Web sites 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 the antibiotic Cipro (ciprofloxacin), 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. Whether new legislation will improve oversight of online pharmacies remains to be seen. For the moment, regulators have entered what the FDA's Shuren calls "a whole new ball game" that cuts across the limited jurisdictions of several federal and state agencies.
Overseeing Online Sales
State medical boards regulate medical practice, while state pharmacy boards oversee pharmacy practice. The 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.
The 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 the FDA being involved is that states have difficulty enforcing their laws across state boundaries. If one state successfully shuts down sales of products by an illegal Web site 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 Web site, that operation is out of business in all states.
In July 1999, the 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. These organizations have made a commitment 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, the 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 given 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.
In July 1999, 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 FTC 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 the 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. The FDA is working closely with the FTC on Operation Cure.All by issuing "cyber letters" to advise and educate operators of Web sites that may not know that the products they are marketing may not be in compliance with federal law. In addition to sending warning letters, the FDA has also taken more serious regulatory actions by seeking permanent injunctions against the marketing of four unapproved drug products being illegally promoted as treatments for cancer.
More than a dozen states also have taken some kind of action against Internet pharmacies, including Kansas, which in 1999 prohibited several pharmacies from operating illegal Web-based businesses within the state.
Industry Polices Itself
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. In late 1999, 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:
- maintaining all state licenses in good standing
- allowing information about the pharmacy to be posted and maintained on the VIPPS Web site.
- allowing an NABP-sanctioned team to inspect its operations, given reasonable notice
- displaying and maintaining the VIPPS seal with a link to the VIPPS Web site
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 its June 1999 annual meeting, the American Medical Association adopted guidelines for doctors that specifically address Internet prescriptions. These voluntary principles recommend that doctors who prescribe over the Internet follow minimum standards of care. This includes examining a patient to determine the medical problem, discussing the risks and benefits of a drug with the patient, and following up to ensure the patient does not experience serious side effects.
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.
The FDA has launched a public education campaign to increase consumer awareness of the risks and benefits of buying prescription drugs online. The campaign uses several different approaches--including the FDA Web site, radio and print public service announcements, a newspaper article, a brochure, and outreach by public affairs specialists based in the FDA's field offices around the country--to broadcast the FDA's message.
"Consumers need to know the risks of buying prescription drugs online so they can remain vigilant," says the 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 member of FDA's website management staff.
How Online Sales Work
In general, legitimate online pharmacies operate this way:
- Users open an account with the pharmacy, submitting credit and insurance information. The pharmacy is licensed to sell prescription drugs by the state in which it operates and in those states to which it sells, if an out-of-state license is required.
- After establishing an account, users must submit a valid prescription. Doctors can call it in or in some states e-mail it, or users can deliver it to the pharmacy by fax or mail. The site then verifies each prescription before dispensing the medication. A written verification policy is usually posted on the site.
- Some online pharmacies send products from a central spot, while others allow users to pick the prescription up at a local drugstore. Prescriptions usually are delivered within three days, often for no shipping charge. For an extra fee, many sites will deliver overnight.
- Sites typically have a mechanism for users to ask questions of the pharmacist, either through e-mail or a toll-free number.
What Consumers Can Do
With hundreds of drug-dispensing Web sites 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 the 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 check the place out."
The FDA offers these tips to consumers who buy health products online:
- Check with the National Association of Boards of Pharmacy to determine if the site is a licensed pharmacy in good standing (visit the Web site at www.nabp.net, or call 847-698-6227).
- Don't buy from sites that offer to prescribe a prescription drug for the first time without a physical exam, sell a prescription drug without a prescription, or sell drugs not approved by the FDA.
- Use sites that provide convenient access to a licensed pharmacist who can answer your questions.
- Avoid sites that do not identify with whom you are dealing and do not provide a U.S. address and phone number to contact if there's a problem.
- Beware of sites that advertise a "new cure" for a serious disorder or a quick cure-all for a wide range of ailments.
- Be careful of sites that use impressive-sounding terminology to disguise a lack of good science or those that claim the government, the medical profession, or research scientists have conspired to suppress a product.
- Steer clear of sites that include undocumented case histories claiming "amazing" medical results.
- Talk to your health-care practitioner before using any medication for the first time.
If you suspect a site is illegal, you can report it to the FDA by using the online reporting form on the agency's Web site.
Publication No. (FDA) 01-3235