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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.