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counterfeit or outdated drugs.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:
- the privacy and convenience of ordering medications from
- 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
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
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
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.
is a voluntary certification program. The fairly rigid conditions
the online pharmacy must agree to for acceptance into the program
- maintaining all state licenses in good standing
- 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
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."
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
- 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
- Check with the National Association of Boards of Pharmacy
to determine if the site is a licensed pharmacy in good standing.
- 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
- 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