[CTRL] Clinton Pushes Net Drug Rules

[Shane A. Saylor, Eccentric Bard]

 -Caveat Lector-

Clinton Pushes Net Drug Rules
Plan Requires Web Sites to Get Federal Approval


By Laura Meckler
The Associated Press
W A S H I N G T O N, Dec. 27 —Hoping to stem illegal sales of prescription
drugs over the Internet, President Clinton is proposing new laws that would
require Web sites to get federal approval and that would stiffen fines for
violators.
     Clinton also wants $10 million for the Food and Drug Administration to
strengthen enforcement, officials said today.
     “Many of the traditional safeguards that have been in place for many
years are breaking down,” FDA Commissioner Jane Henney said. “We have to
have a way to keep some semblance of a safety net in place.”
     New laws and new money would have to be approved by Congress.
     Traditionally, states have regulated pharmacies. But the Internet poses
new, interstate challenges, in which a Web site operator may be in one
state, the pharmacist in another and a patient in a third, Henney noted.
     In many cases, legitimate online pharmacies make it easy and convenient
for consumers to get the drugs they need delivered to their doors,
particularly for people in rural areas and the homebound.
Drugs Sent Without Prescription
But there have been several cases in which Web sites sent drugs out without
a valid prescription or dispensed drugs that were not legally available in
the United States.
     The FDA recently uncovered illegal at-home AIDS tests sold via the
Internet that didn’t work, meaning some people may have thought they were
healthy when they had the deadly HIV virus.
     The FDA also has pointed to a 53-year-old Chicago man who died after
taking the impotence pill Viagra he ordered via the Internet. He never saw a
doctor who could have advised him that he had heart disease risks that make
taking Viagra dangerous.
     “Traditionally, there have been several safeguards to protect consumers
against unsafe use of drugs,” the White House said in a draft of a fact
sheet to be released Tuesday. “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.”
     The administration has said repeatedly it is not interested in
regulating the Internet, hoping to avoid stifling the growing medium. But
officials said they must protect consumers, who may not know whether an
online drugstore is legitimate or whether its pharmacists have been properly
trained.

FDA Launches Web Page
Last week, the FDA opened a consumer-advice Web page to help patients ensure
they’re buying from legitimate stores instead of dangerous quacks.
     But the agency has been frustrated in its crackdown effort. Under
current federal law, it is only a misdemeanor to improperly dispense drugs.
     Under Clinton’s proposal:
 Online pharmacies would be required to get FDA certification that they are
legally operating or face sanctions.
 Violators would face a $500,000 fine for each time they sold a prescription
drug to someone without a valid prescription.
 The FDA would get new power to subpoena the records of online sites while
investigating these operators.
 The FDA would get $10 million in the 2001 budget to hire investigators and
upgrade computer equipment.
     It is unclear how these rules, even if approved, would affect Web sites
operating out of other countries.

Congressional Response Unclear
The White House also plans a public education campaign, using $250,000 of
FDA money budgeted this year for a variety of other programs. It will
include ads on health Web sites and public service announcements for
television.
     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. But Henney
is optimistic. “We think Congress is interested in the Internet overall,”
she said.
     With the exception of child pornography, the Internet has been largely
unregulated by government.
     But other regulations will probably come as government tries to apply
long-standing laws to cyberspace, said Tara Lemmey, president of the San
Francisco-based Electronic Frontier Foundation, which tracks Internet public
policy.
     “This may be the first of a series of these that we see,” she said.


--
He who sees the truth, let him proclaim it, without asking who is for it or
who is against it. -Henry George

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