http://www.fda.gov/oc/buyonline/onlinesalespr.html

                              THE WHITE HOUSE

                       Office of the Press Secretary
For Immediate Release                                December 28,1999
THE CLINTON ADMINISTRATION UNVEILS NEW INTIATIVE TO PROTECT CONSUMERS BUYING
PRESCRIPTION DRUG PRODUCTS OVER THE INTERNET
The White House today will announce that President Clinton is proposing a new
initiative to protect consumers from the illegal sale of pharmaceuticals over
the Internet. The initiative, which will be included in this year's budget,
would: establish new Federal requirements for all Internet pharmacies to
ensure that they comply with state and Federal laws; create new civil
penalties for the illegal sale of pharmaceuticals; give Federal agencies new
authority to swiftly gather the information needed to prosecute offenders;
expand Federal enforcement efforts; and launch a new public education
campaign about the potential dangers of buying prescription drugs online. The
President's FY 2001 budget will include $10 million to fund these and other
activities.

UNSUSPECTING CONSUMERS MAY FALL PREY TO FLY-BY-NIGHT INTERNET PHARMACIES.

Use of the Internet to buy medical products is growing rapidly, and many
consumers, including those in rural areas or those who cannot leave their
homes, benefit from the convenience and privacy of this new option.
Unfortunately, the safe use of the Internet by both consumers and businesses
is now being threatened by fraudulent or disreputable Internet pharmacies
that sell products illegally.

Internet Pharmacies Can Bypass Safeguards. Traditionally there have been
several safeguards to protect consumers against unsafe use of drugs,
including the requirement that drugs be dispensed only for valid
prescriptions and that new prescriptions be issued only after a physical
exam. The Internet makes it easy to bypass these safeguards. Unethical
doctors can illegally prescribe pills online to consumers they have never met
in states where they are not authorized to work. Unscrupulous, unlicensed
pharmacies can ship pills across state lines.

Fly-By-Night Internet Pharmacies Put Online Consumers at Increased Risk. In
cyberspace, consumers have no way of telling whether an online pharmacy is a
legitimate operation. Consumers who buy prescription drugs online from
illegitimate websites are at risk for adverse effects from inappropriately
prescribed medications, dangerous drug interactions, or contaminated drugs.
Some online pharmacies do not employ licensed pharmacists, removing an
important safety check. And because patients can easily provide false
information to obtain medications, the potential for serious abuse exists.

Federal Authority to Prosecute is Limited, Penalties are Inadequate. Because
of some limitations on Federal authority, it has been difficult for FDA to
take action against certain offenders, such as online corporations that
employ licensed physicians who prescribe drugs without taking a consumer's
medical history or checking for potential drug interactions. And even where
FDA has authority to prosecute, the penalties in most cases are not adequate
and may not be enough to deter these fly-by-night operations.


CLINTON-GORE ADMINISTRATION TAKES NEW STEPS TO PROTECT CUSTOMERS OF ONLINE
PHARMACIES.

Today, the Clinton-Gore Administration will unveil a new legislative proposal
that addresses these problems. Specifically, the initiative:

Enables Consumers to Identify Legitimate Pharmacy Sites. This proposal
establishes a new Federal requirement to enable consumers to identify
legitimate Internet pharmacy sites. Sites would have to demonstrate to FDA
their compliance with Federal and state law on pharmaceutical sales before
they received approval to operate. Sites operating without first
demonstrating FDA compliance would be subject to sanctions. This system would
allow for rapid, coordinated Federal-state investigations and prosecutions
without disturbing state systems regulating the practice of medicine and
pharmacy.

Strengthens the Current Penalty Structure For Illegal Pharmaceutical Sales
Over The Internet. This proposal creates new civil money penalties of
$500,000 per violation for the sale of prescription drug to an individual
without a valid prescription.

Provides New Authority to FDA in Order to Ensure Rapid and Effective
Investigation of On-Line Sites. In order to streamline the investigative
process, this proposal also provides FDA with administrative subpoena
authority when investigating potentially illegal Internet drug sales.
Administrative subpoenas would be issued in accordance with standards
established by the Administration's draft privacy regulations.


In addition, the White House will also:


Unveil A New $10 Million Investment to Target and Punish Those Who Engage in
Illegal Drug Sales Over the Internet. The FY 2001 budget will invest $10
million to develop a rapid response team and upgrade FDA's computer
technology to identify, investigate, and prosecute websites selling such
items as: prescription drugs without a valid prescription, unapproved new
drugs, counterfeit drugs, and expired or illegally diverted pharmaceuticals.
This initiative will also help crack down on the marketing of products based
on fraudulent health claims.

Announce Plans for a New Public Education Campaign on the Dangers Of Buying
Pharmaceuticals Online. In the beginning of the new year, FDA will launch a
new public education campaign about safe ways to purchase pharmaceutical
products over the Internet. The campaign will include: placing advertisements
on health related websites; taping public service announcements for
distribution to television stations nationwide; and developing a "safety
checklist" to be posted online and distributed through health care providers
and consumer advocacy organizations.



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http://www.fda.gov/oc/buyonline/onlinesalespr.html

--

FDA Homepage | Buying Medical Products Online
HHS NEWS
U.S. Department of Health and Human Services

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P99-33                                         FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE                          Print Media:
301-827-6242
December 20, 1999                              Broadcast Media:
301-827-3434
                                               Consumer Inquiries:
888-INFO-FDA
FDA ANNOUNCES NEW INTERNET WEBSITE
TO PROVIDE CONSUMERS WITH INFORMATION ABOUT BUYING
PRESCRIPTION DRUGS AND MEDICAL PRODUCTS ONLINE
The Food and Drug Administration today announced that it has established a
new Internet Website to provide consumers with useful, easy-to-understand
information about buying prescription drugs and medical products online. This
public outreach initiative is part of FDA's action plan to increase public
awareness about the health, economic, and legal risks of online sales of
prescription drugs and medical products.
Increasingly, consumers are using the Internet to purchase medical products.
Due to the ease with which a Website can be created, a site may appear to be
a legitimate pharmacy when in fact both the seller and the product sold are
illegitimate. Consumers need to know the risks, and how they can protect
themselves, when buying prescription drugs and medical products on the
Internet.

"The development of the Internet has opened up many new options for consumers
to purchase products more conveniently," said Dr. Jane Henney, Commissioner
of Food and Drugs. "However, the Internet has also provided unscrupulous
individuals with immense new opportunities to promote and sell prescription
drugs unlawfully to unsuspecting patients."

Under the Federal Food, Drug, and Cosmetic Act, FDA has the legal authority
to regulate the safety, effectiveness, manufacturing, labeling, and
advertising of prescription drugs.

By visiting FDA's Website at www.fda.gov and clicking on the "Buying Medical
Products Online?" banner, consumers can now obtain information on how to
protect themselves from dangerous online practices involving the sale of
FDA-regulated products; learn about FDA's enforcement efforts; find out how
to spot health fraud; and get a list of answers to the most commonly asked
questions about Internet drug sales.

Consumers who suspect that a Website is illegally selling human or animal
drugs, medical devices, biological products, foods, dietary supplements or
cosmetics over the Web can also fill out an electronic complaint form
provided at this site, and email it directly to FDA.


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==========================================================
To be GOVERNED is to be watched, inspected, spied upon,
directed, law-driven, numbered, regulated, enrolled,
indoctrinated, preached at, controlled, checked, estimated,
valued, censured, commanded, by creatures who have neither
the right nor the wisdom nor the virtue to do so.  To be
GOVERNED is to be at every operation, at every transaction
noted, registered, counted, taxed, stamped, measured,
numbered, assessed, licensed, authorized, admonished,
prevented, forbidden, reformed, corrected, punished.  It
is, under pretext of public utility, and in the name of
the general interest, to be placed under contribution,
drilled, fleeced, exploited, monopolized, extorted from,
squeezed, hoaxed, robbed; then, at the slightest
resistance, the first word of complaint, to be repressed,
fined, vilified, harassed, hunted down, abused, clubbed,
disarmed, bound, choked, imprisoned, judged, condemned,
shot, deported, sacrificed, sold, betrayed; and to crown
all, mocked, ridiculed, derided, outraged, dishonored.
That is government; that is its justice; that is its
morality.
    - P.J. Proudhon, GENERAL IDEA OF THE REVOLUTION
                     IN THE 19TH CENTURY
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