Copyright 1999 Newsday, Inc.
Newsday (New York, NY)
December 29, 1999, Wednesday ALL EDITIONS
SECTION: NEWS; Page A03
LENGTH: 553 words
HEADLINE:
PLAN: REGULATE WEB PHARMACIES
BYLINE: THE ASSOCIATED
PRESS
DATELINE: Washington
BODY:
Washington-Citing a threat by "rogue
operators," President Bill Clinton yesterday proposed requiring that Internet
sites obtain federal approval for selling prescription drugs or face stiff
fines.
His plan, if approved by Congress, would give the Food and Drug
Administration unprecedented powers to review and certify hundreds of
drug-dispensing Web sites. Violators would face half-million-dollar fines for
each infraction. Clinton said prescription drug sites give consumers good
opportunities to obtain medicines more affordably. But, he said, they also leave
consumers vulnerable to exploitation by those who dispense drugs without
prescriptions or licenses.
"Rogue operators pose a threat to the health
of Americans," Clinton said. His proposal, he added, "sends a signal that we
have zero tolerance for prescription drug Internet sites that ignore federal and
state laws and harm patient safety and health." The move would mark a
significant shift in the regulation of both the Internet and pharmaceuticals.
The Internet has been largely unregulated, with policy-makers loath to stifle
its adolescent development. And the regulation of drug sales is largely the
province of state government.
In fact, the only pertinent federal law on
the books is a misdemeanor that carries a fine of just $ 1,000.
Several
states have moved against Web operators. But Dr. Jane Henney, the FDA
commissioner, said they're stymied by a system in which patients, pharmacists
and Web site operators may well be located in different states.
"Many of
the traditional safeguards that have been in place for many years are breaking
down," Henney said.
The initiative also includes a request for $ 10
million next year to hire about 100 investigators and upgrade computers. Like
the new laws, new money would have to be approved by Congress.
Several
cases have been publicized recently in which Web sites sent drugs out without a
valid prescription or dispensed drugs that were not legally available in the
United States. For instance, the FDA recently uncovered illegal at-home AIDS
tests sold over the Internet that didn't work.
The FDA also has pointed
to a 53-year-old Chicago man who died after taking Viagra he ordered over the
Internet. He never saw a doctor, who could have advised him that he was at risk
of heart disease, which makes taking Viagra dangerous.
Last week, the
FDA opened a consumer-advice Web page (www.fda.gov/oc/buyonline/default.htm) to
help patients ensure they're buying from legitimate stores instead of dangerous
quacks. And the National Association of Boards of Pharmacy is certifying
legitimate online pharmacies.
Customers can check www.nabp.net to see if
a particular Web pharmacy is safe.
But those are voluntary efforts. By
contrast, the federal plan would: Require online pharmacies to get FDA
certification that they are legally operating or face sanctions.
Impose
a $ 500,000 fine each time a site sells a prescription drug without a valid
prescription.
Give the FDA power to subpoena the records of online sites
while investigating these operators.
There remain some hurdles if the
legislation is going to become law. It may be tough getting Congress to give new
money or power to the FDA, which did not get most of its budget requests granted
this year.
LOAD-DATE: December 30, 1999
