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Vioxx | Baycol Home | Why Drugs Get Recalled | Buying Drugs Online | Drugs To Watch Questions & Answers 
It's Convenient and Private, but Beware of 'Rogue Sites' 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way sets the stage for problems that include dangerous drug interactions and harm from contaminated, counterfeit or outdated drugs.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:
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. Fraudulent Products 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:
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." - From the January-February 2000 FDA Consumer magazine. 1. Why is FDA concerned about unlawful drug sales on the Internet? 2. Are there any benefits to purchasing approved drugs online? 3. How many web sites sell prescription drugs? 4. How many people have been harmed from drugs purchased over the Internet? 5. If FDA is not aware of adverse events associated with approved drugs sold online, why does the agency think that unlawful online sale is a big problem? 6. Why shouldn't the online pharmacy industry be self-regulated? 7. Some Websites offer to prescribe medication based only on a questionnaire. Is this a safe practice? Is it legal? 8. How many states have acted against web sites selling prescription drugs? 9. Who will FDA refer complaints to at the state level? 10. How will FDA integrate its efforts with the White House Electronic Commerce Working Group? 11. What are international organizations like WHO doing about Internet prescribing and dispensing? 12. Can an American patient get a medication not approved in the U.S. from a foreign dispenser? 13. Is it illegal for a foreign pharmacy to ship prescription medicines into the U.S.? 1. Why is FDA concerned about unlawful drug sales on the Internet? Patients who buy prescription drugs from Websites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs. The current system of federal and state safeguards for protecting patients from the use of inappropriate or unsafe drugs has generally served the country well. These laws require that certain drugs be dispensed only with a valid prescription because they are not safe for use without the supervision of a licensed health care practitioner. Generally, before the practitioner issues a prescription for a drug the patient has never taken before, he or she must first examine the patient to determine the appropriate treatment. Subsequently, the patient receives the drug from a registered pharmacist working in a licensed pharmacy that meets state practice standards. The Internet makes it easy for unscrupulous people to sell drugs to patients without these safeguards in place. A Website may appear to be associated with a legitimate pharmacy when in fact it is not. Websites that sell prescription drugs without a valid prescription deny consumers the protection provided by an examination conducted by a licensed practitioner. 2. Are there any benefits to purchasing approved drugs online? Yes. Legitimate pharmacy sites on the Internet provide consumers with a convenient, private, way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home. Moreover, Internet pharmacies can provide customers with written product information and references to other sources of information like the traditional storefront pharmacy. Finally, the increasing use of computer technology to transmit prescriptions from doctors to pharmacies is likely to reduce prescription errors. 3. How many web sites sell prescription drugs? 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 service. According to a recent Chicago Tribune article cited by the American Medical Association, there are at least 400 web sites that both dispense and offer a prescribing service -- half of these sites are located in foreign countries. Some have estimated that the number of Websites selling prescription drugs may now be closer to 1,000. The number of Websites, however, fluctuates from day to day, and seems to be growing. 4. How many people have been harmed from drugs purchased over the Internet? It is impossible to accurately quantify adverse event rates because FDA's postmarketing surveillance system receives reports on only a relatively small percentage of all adverse events caused by drugs. However, as a result of postmarketing surveillance data collected by FDA, we know that the sale of unapproved drugs and the illegal sale of approved drugs over the Internet poses a serious public health risk. We know, for example, of many adverse events resulting from the use of the drug GBL and the date rape drug GHB, which are unapproved drugs sold illegally over the Internet. FDA learned recently of a person who was harmed by the use of Viagra purchased from a Website without an examination by a healthcare professional. Unfortunately, the man had a family history of heart disease and died after taking the drug. We also know of cases where people choose the Internet for treatment to avoid consulting a health care professional. These consumers, however, run the risk of purchasing inappropriate drugs or unknowingly purchasing counterfeit or sub-potent drugs. 5. If FDA is not aware of adverse events associated with approved drugs sold online, why does the agency think that unlawful online sale is a big problem? We know that adverse events are under-reported and we know from history that tolerating the sale of unproven, fraudulent, or adulterated drugs results in harm to the public health. It is reasonable to expect that the illegal sale of drugs over the Internet and the number of resulting injuries will increase as sales on the Internet grow. Without clear and effective law enforcement, violators will have no reason to stop their illegal practices. Unless we begin to act now, unlawful conduct and the resulting harm to consumers most likely will increase. 6. Why shouldn't the online pharmacy industry be self-regulated? Industry self-regulation has a role to play when applied to legitimate businesses. However, self-regulation is an insufficient mechanism to control illegal practices. 7. Some Websites offer to prescribe medication based only on a questionnaire. Is this a safe practice? Is it legal? Unlike the traditional relationship between a patient and the patient's health care professional, some online practitioners issue prescriptions in the absence of a physical examination or direct medical supervision. According to the American Medical Association, a health care professional who offers a prescription for a patient the practitioner has never seen before and based solely on an online questionnaire generally has not met the appropriate medical standard of care. As a result, patients may receive a drug that is inappropriate for them to use and may sacrifice the opportunity for a correct diagnosis or the identification of an underlying medical condition for which use of the prescription drug may be dangerous. It is a violation of the Federal Food, Drug, and Cosmetic Act to dispense prescription drugs without a valid prescription. FDA will work with the states to determine the validity of online prescriptions and to bring enforcement actions under state law, federal law, or both, as appropriate. In addition, several state boards of medicine have ruled that such practice is medical misconduct and have fined and suspended the licenses of health care practitioners who have prescribed drugs in this manner. 8. How many states have acted against web sites selling prescription drugs? Several states have taken or are contemplating 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. Although most of these cases involve cease and desist orders, some states have assessed fines and are contemplating stiffer penalties. One state has issued a temporary restraining order against an Internet pharmacy selling drugs without a valid prescription. 9. Who will FDA refer complaints to at the state level? FDA has been working with the National Association of Boards of Pharmacy, the Federation of State Medical Boards, and the National Association of Attorneys General to establish points of contact in all states specifically for Internet related problems. Both the FDA and NABP Websites have online reporting forms for consumers to use in referring complaints to the appropriate regulatory authorities. 10. How will FDA integrate its efforts with the White House Electronic Commerce Working Group? FDA believes its activities will complement those of the White House working group and are consistent with the Administration's July 1997 Framework for Global Electronic Commerce and the President's November 1998 Memorandum on Successes and Further Work on Electronic Commerce. Effective consumer protection is necessary to foster legitimate electronic commerce. Because legitimate electronic commerce activities may involve the practice of medicine or the practice of pharmacy, FDA will work with state law enforcement and regulatory bodies to better define the boundaries of legitimate online practices. By reducing the availability of illegal and harmful products in the electronic commerce marketplace, FDA enforcement activities will increase consumer confidence in the Internet. 11. What are international organizations like WHO doing about Internet prescribing and dispensing? The World Health Organization is in the process of developing a guide entitled "Medical Products and the Internet." In addition to providing tips on finding reliable health and medical information on the Internet, it will provide advice on buying medical products online. FDA participated in the development of this guide. 12. Can an American patient get a medication not approved in the U.S. from a foreign dispenser? As a general matter, it is illegal to import an unapproved drug into the U.S. However, under FDA's personal importation policy, FDA has authorized its inspectors to use their enforcement discretion to allow U.S. residents to import certain products under certain limited conditions. Under this policy, FDA may allow a U.S. resident to bring into this country an unapproved drug for their personal use for a serious condition, if there has been no commercialization or promotion of the drug to U.S. residents. 13. Is it illegal for a foreign pharmacy to ship prescription medicines into the U.S.? It is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by FDA into the U.S. even though the drug may be legal to sell in that pharmacy's country. Under the scheme that Congress established to ensure that drugs are safe and effective, drugs are tested and test results are thoroughly reviewed by FDA scientists. 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 registered with FDA, and be produced under quality standards enforced by FDA. Prescription drugs available from a foreign pharmacy that are products that FDA has not approved; 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; or products not stored or distributed under the quality conditions required in the U.S. cannot be legally sold in the U.S.
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