FCIC - Buying Drugs Online

The version below is from a reprint of the original article and containsrevisions made in June 2000.

by John Henkel

The scene is becoming increasingly common in the United States: Consumers arereplacing a trip to the corner drugstore with a click onto the Internet, wherethey find hundreds of Websites selling prescription drugs and other healthproducts.

Many of these are lawful enterprises that genuinely offer convenience,privacy, and the safeguards of traditional procedures for prescribing drugs. Forthe most part, consumers can use these services with the same confidence theyhave in their neighborhood pharmacist. In fact, while some are familiar largedrugstore chains, many of these legitimate businesses are local "mom andpop" pharmacies, set up to serve their customers electronically.

But consumers must be wary of others who are using the Internet as an outletfor products or practices that are already illegal in the offline world. Theseso-called "rogue sites" either sell unapproved products, or if theydeal in approved ones, often sidestep established procedures meant to protectconsumers. For example, some sites require customers only to fill out aquestionnaire before ordering prescription drugs, bypassing any face-to-faceinteraction with a health professional.

"This practice undermines safeguards of a direct medical supervision andphysical evaluation performed by a licensed health professional," saysJeffrey Shuren, M.D., medical officer in the Food and Drug Administration'sOffice of Policy, Planning and Legislation. "The Internet makes it easy tobypass this safety net."

Skirting the system this way sets the stage for problems that includedangerous drug interactions and harm from contaminated, counterfeit or outdateddrugs. "Websites that prescribe based on a questionnaire raise additionalhealth concerns," says Shuren. "Patients risk obtaining aninappropriate medication and may sacrifice the opportunity for a correctdiagnosis or the identification of a contraindication to the drug."

To date, FDA has received only a few reports of adverse events related toInternet drug sales, but some of these cases point out the potential danger ofbuying prescription drugs on the basis of just a questionnaire. For example, a52-year-old Illinois man with episodes of chest pain and a family history ofheart disease died of a heart attack in March 1999 after buying the impotencedrug Viagra (sildenafil citrate) from an online source that required onlyanswers to a questionnaire to qualify for the prescription. Though there is noproof linking the man's death to the drug, FDA officials say that a traditionaldoctor-patient relationship, along with a physical examination, may haveuncovered any health problems such as heart disease and could have ensured thatproper treatments were prescribed.

FDA is investigating numerous pharmaceutical Websites suspected of breakingthe law and plans to take legal action if appropriate. The agency has madeInternet 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. Accordingto the market research firm Cyber Dialogue Inc., health concerns are the sixthmost common reason people go online. Internet drugstores, however, won't make"brick and mortar" pharmacies obsolete anytime soon. Over 3 billionprescriptions were dispensed in 1999, and though no reliable figures gaugingtotal online sales are yet available, industry sources say that number is likelystill fairly small.

For some people, buying prescription drugs online offers advantages notavailable from a local drugstore, including:

Internet drug shopping also purports to save consumers money. In some casesthis is true. A survey in the fall of 1999 by Consumer Reports showed thatbuyers could save as much as 29 percent by obtaining certain drugs online. Butanother study, conducted in 1999 by the University of Pennsylvania and publishedin the Annals of Internal Medicine, tracked Internet sales of Viagra andPropecia and found that the two drugs were an average of 10 percent moreexpensive online than at local Philadelphia-area pharmacies.

In another part of that study, researchers Bernard Bloom, Ph.D., and RonaldIannocone found that 37 of the 46 sites they examined either required aprescription from a personal physician or offered to prescribe a medicationbased solely on a questionnaire. But nine sites, all based outside the UnitedStates, did not require a prescription. The researchers also found that evenwhen Websites offered a questionnaire with the promise that a physician wouldreview 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 FDAofficials say are legally questionable. A number of them specialize in providingdrugs such as Viagra, the baldness therapy Propecia (finasteride), or theweight-loss treatment Xenical (orlistat). Others, based in foreign countries,promise to deliver prescription drugs at a much cheaper price than theirdomestic cost, but the drugs may be different from those approved in the UnitedStates or may be past their expiration dates. Still other sites make fraudulenthealth claims or blatantly advertise that a customer can buy drugs with noprescription. Online drug sites can now be located in nearly any state orcountry 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 tothe public," says Rep. Ron Klink (D-Pa.), who is sponsoring Internetpharmacy legislation. "Buyers have no way of knowing whether a site islicensed or if the site uses licensed doctors or pharmacists or even in whatstate they are located." Klink's bill would require Internet-basedpharmacies to list the name, address and phone number of the principal place ofbusiness, the name of each pharmacist and health professional who providesmedical consultation, and the states where the pharmacy, pharmacists, and otherhealth professionals are licensed.

Certain pharmacy industry representatives oppose legislation or additionalpowers for regulatory agencies on the premise that current laws are sufficientto address the problem. "There are [controls] already in place forregulating pharmaceutical sales," says Mary Ann Wagner, vice president ofpharmacy regulatory affairs for the National Association of Chain Drug Stores."That hasn't changed."

Overseeing Online Sales

Whether new legislation will improve oversight of online pharmacies remainsto be seen. For the moment, regulators have entered what FDA's Shuren calls"a whole new ball game" that cuts across the limited jurisdictions ofseveral federal and state agencies. State medical boards regulate medicalpractice, while state pharmacy boards oversee pharmacy practice. FDA and theFederal Trade Commission ensure that drug sellers make legal claims for theirproducts. 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 pharmaceuticaldrugs, as well as a part of the prescribing process. "It is a violation ofthe Food, Drug, and Cosmetic Act to sell a prescription drug without a validprescription," says Shuren. "Therefore, FDA can take action againstsites that bypass this requirement." He adds that the advantage of FDAbeing involved is that states have difficulty enforcing their laws across stateboundaries. If one state successfully shuts down an illegal Website within itsborders, the site theoretically still has 49 other potential locales in which tosell. However, if the federal government shuts down an illegal Website, thatoperation is out of business.

In July 1999, FDA announced that it was joining forces with state regulatoryagencies and law enforcement groups to combat illegal domestic sales ofprescription drugs. The agency signed agreements with the National Associationof Boards of Pharmacy and the Federation of State Medical Boards. Theseorganizations have made a commitment to help enforce federal and state lawsagainst unlawful Internet sellers and prescribers of drugs in the United States.

Though regulating Internet sales of health products is still fairly new, FDAhas successfully taken action in the past against illegal sites. For example, aCalifornia company called Lei-Home Access Care in 1996 and 1997 used theInternet to sell a home kit advertised as a blood test for the AIDS virus. Notonly was the kit unapproved, but the maker also fabricated test results given tousers who submitted a drop of blood. After an extensive FDA investigation, thesite was shut down, and its operator, Lawrence Greene, was sentenced to morethan 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 forproducts and treatments touted as cures for various diseases. Over two years,the FTC identified about 800 sites and numerous Usenet newsgroups containingquestionable promotions.

"Miracle cures, once thought to be laughed out of existence, have founda new medium," says Jodie Bernstein, director of FTC's Bureau of ConsumerProtection. "Consumers now spend millions on unproven, deceptively marketedproducts on the Web."

As part of the program, four companies settled FTC charges of deceptivehealth claims. These included sites that claimed to cure arthritis with a fattyacid derived from beef tallow, to treat cancer and AIDS with a Peruvian plantderivative, 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 ownregulatory actions, such as sending warning letters to help ensure that falseand misleading statements are removed from the Internet.

More than a dozen states also have taken some kind of action against Internetpharmacies, including Kansas, which in 1999 prohibited several pharmacies fromoperating illegal Web-based businesses within the state.

Industry Polices Itself

At the same time that regulatory agencies are stepping up enforcement effortsagainst illegal online drug sales, professional organizations are launchingprograms with the goal of cleaning house from within. In late 1999, the NationalAssociation of Boards of Pharmacy (NABP) unveiled its Verified Internet PharmacyPractice Sites (VIPPS) program, which provides consumers valuable informationabout the credentials of online pharmacies.

VIPPS is a voluntary certification program. The fairly rigid conditions theonline 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 oftenthe target of unscrupulous marketing ploys," says Kevin Kinkade, NABPexecutive committee chairman. "VIPPS will be of tremendous benefit toconsumers who need to be certain that the prescription medications they receiveare from legitimate online pharmacies." To date, six businesses have beenawarded VIPPS certification: drugstore.com, Merck-Medco Managed Care L.L.C.,planetRx.com, familymeds.com, CVS Washington Inc., and Tel-Drug Inc.

At its June 1999 annual meeting, the American Medical Association adoptedguidelines for doctors that specifically address Internet prescriptions. Thesevoluntary principles recommend that doctors who prescribe over the Internetfollow minimum standards of care. This includes examining a patient to determinethe medical problem, discussing the risks and benefits of a drug with thepatient, and following up to ensure the patient does not experience serious sideeffects.

Many in the pharmaceutical industry back the AMA's action. "Therelationship between physician and patient is critically important, " saysMartin Hirsch, public affairs director for Roche Laboratories Inc., maker ofXenical. "We support guidelines that will ensure that this relationshipcontinues."

With regulatory and voluntary actions in full swing, it still will be hard tostay 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 theissue," says Wagner of the National Association of Chain Drug Stores.

FDA plans to help increase public awareness with an education campaign thatinforms consumers about the health, economic and legal risks of online sales ofmedical products. The campaign also will target health-care practitioners andindustry. Other federal and private groups are conducting similar outreach.

"Consumers need to know the risks of buying prescription drugs online sothey can remain vigilant," says FDA's Shuren, " The public also needsto know," he adds, "that there's a price to pay for operating anillegal Internet pharmacy. Even bringing a few highly publicized cases into thepublic eye will send a powerful message that these illegal sites will not betolerated."

John Henkel is a member of FDA's Website Management Staff.

In general, legitimate online pharmacies operate this way:

--J.H.

With hundreds of drug-dispensing Websites in business, how can consumers tellwhich sites are legitimate ones, especially when it is very easy to set up asite that is very professional-looking and promises deep discounts or a minimumof hassles?

"Consumers need to be cautious," says Jeffrey Shuren, M.D., medicalofficer in FDA's Office of Policy, Planning and Legislation. "You shoulduse the same kind of common sense you use when buying from any business. Youlook for a reputable dealer. You get recommendations from friends. You check theplace 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 visiting theagency's website at www.fda.gov andusing the online reporting form.