THE WHITE HOUSE
Office of the Press Secretary
For Immediate Release December 28,1999
The Clinton Administration Unveils New Initiative
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.
Frequently Asked
Questions About White House Initiative
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