01-15-2000

CONGRESS: Diagnosis Improves for Cyberpharmacy Bill

When Congress adjourned last November, Rep. Ron Klink, D-Pa., was feeling
downright gloomy about his chances of getting legislation passed to better
regulate the sale of prescription drugs over the Internet.


Klink was just about the only member of Congress fighting for the
legislation. His Republican colleagues said they did not want to stifle
the growth of electronic commerce and favored a more cautious approach to
the issue. And the Clinton Administration, also sympathetic to the
blossoming world of e-commerce, had been mostly silent.


But on Dec. 28, Klink's pessimism quickly turned to hopeful excitement
when President Clinton announced a plan to guard consumers against
unscrupulous online medicine sellers. Klink became even more optimistic
when Jane Henney, the head of the Food and Drug Administration, called and
asked him to help work on drafting bipartisan legislation. (This
invitation came despite the fact that Klink earlier had hammered the FDA
for failing to devote adequate resources to the problem.)


"It felt a little bit like being at the Alamo," Klink said in an
interview. "It was very exciting when the reinforcements arrived.
This is an incredible amount of relief for us."


Since then, the Senate Health, Education, Labor, and Pensions Committee
has also become involved. Sen. James M. Jeffords, R-Vt., the committee's
chairman, is planning three hearings to examine the issue and determine
whether legislation is merited. The first is scheduled for Jan. 25-during
the first week that Congress will be back in session.


Facing a potential legislative flurry, the largest cyberpharmacies have
already begun securing outside lobbying help to protect their booming
businesses. At least 400 cyberpharmacies are now open on the Internet; at
the beginning of 1999, around 50 such Web sites existed. (For an in-depth
look at online prescription drug sales, see NJ, 11/13/99, p. 3310.) Some
of these Web sites are legitimate and follow the same general rules that
corner drugstores must live by: They require the purchaser to send in a
written doctor's prescription before they'll dispense prescription drugs,
and they do business only in states where they are licensed.


Other cyberpharmacies, however, operate illegally, by handing out drugs
without a prescription. Some charge a fee to have their own anonymous
"cyberdoctor" write a prescription, with few questions asked; or
they sell prescriptions to people who live in states where they are not
licensed.


For consumers, it has become easy to purchase through the Internet
potentially dangerous or highly addictive prescription medicines, such as
codeine, without medical supervision. The American Medical Association has
complained that cyberdoctors cannot possibly write valid prescriptions
without having personally examined patients. Plenty of Web sites don't
disclose the identity of their cyberdoctors or their qualifications.
Moreover, the danger in buying prescription drugs from an unknown
pharmacy, or one that is based overseas, is that the medication may be
expired, it may be subpotent or superpotent, or it may even be
counterfeit.


State regulatory agencies already have some authority to go after
cyberpharmacies that sell prescription drugs illegally in their state. But
only a few states-Illinois and Kansas, for instance-have begun cracking
down on offenders. Part of the difficulty for state officials is that many
pharmaceutical Web sites don't say which states have licensed them, or in
which state they are physically located.


Legislation that Klink introduced last year would require cyberpharmacies
to disclose online whom they have received accreditation from and where
they are licensed to practice. The intention is to ensure that consumers
have enough information to make smart purchasing decisions. Klink also
hopes his bill would give state enforcers the help they need to track down
illegal operators.


Clinton went further in his plan, which he is expected to elaborate upon
in his fiscal 2001 budget proposal, due for release on Feb. 7. Klink has
told the FDA's Henney that he is willing to alter the language in his
legislation "if we could achieve the same kind of
goals."


Clinton wants Congress to pass legislation that would give the FDA new
authority to approve or deny all cyberpharmacies. Web sites would be
required to demonstrate to the FDA their compliance with both federal and
state laws on pharmaceutical sales. Cyberpharmacies that fail the test, or
ignore it, 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," said a Clinton Administration statement.


Clinton's plan would also institute federal penalties. Cyberpharmacies
that sell medicine without a valid prescription would have to pay $500,000
per violation in civil penalties. In addition, the FDA would get new
administrative subpoena authority to investigate potentially illegal
sales. And, as part of his fiscal 2001 budget, Clinton will propose giving
the FDA $10 million to develop a rapid-response team on the issue and to
upgrade its computer technology.


Neither Clinton's nor Klink's proposal addresses the cyberpharmacies that
are the hardest to oversee-those that are based overseas. "It's a
very difficult issue," said a White House official. Foreign Web sites
aren't required to follow our state requirements, and most foreign
countries have a more-relaxed set of rules by which to sell medicine. The
White House official suggested that simply requiring domestic sites to
become certified might, "in and of itself, decrease the appetite for
those sites that don't have certification, whether [they're] foreign or
not."


Klink said he believes that with Clinton's leadership, the chances are
greatly improved for passing a bill this year to regulate online
pharmacies. "Just the bully pulpit of the presidency, having him talk
about it, and motivate the FDA-he brings a lot of influence to the
process," Klink said.


Klink will need all the help he can get. House Commerce Committee Chairman
Tom Bliley, R-Va., whose panel has primary jurisdiction over the issue,
didn't support the legislation before Clinton made his announcement, and
he doesn't now, according to a panel spokesman. Bliley agreed, after a
little pressure from colleagues, to hold one hearing on the subject last
July, at which he and other Republican committee members made clear that
they intended to move slowly on the regulation of e-commerce.


Bliley is not planning on introducing or considering legislation on
cyberpharmacies in his committee this year, said his spokesman. The
chairman "is not going to be a quick draw to regulate when we don't
know in what way this is going to develop," said his aide.
"Certainly we don't want to regulate when the issue is that states
are not enforcing laws that are already on the books."


While Klink conceded that enthusiasm from Bliley would be helpful, he
contends that it is not essential to passing a bill. "Perhaps Mr.
Bliley will not be part of it," said Klink. "But eventually,
there will be Republican legislators who will understand the seriousness
of what we are all allowing to occur."


Proponents of cyberpharmacy legislation point out that Bliley at first was
slow to move a patients' bill of rights through the Commerce Committee
last year, but eventually gave in amid continuous pressure from the
panel's Democrats and a small handful of Republicans with medical
backgrounds. "There's an old saying that when the people lead, the
leaders follow," said Klink. "This may have to come from other
Republicans."


In the meantime, four of the biggest online pharmacies, CVS.com,
drugstore.com, Merckmedco.com, and PlanetRX.com, are gearing up for a
lobbying campaign on any proposed cyberpharmacy legislation. Those four
pharmacies have obtained voluntary certification in all 50 states from the
National Association of Boards of Pharmacy. That certification represents
the industry's efforts to-on its own-help distinguish legitimate from
illegal operators.


A spokeswoman for PlanetRX.com said that to combat problems with online
drug sales, Congress and the Clinton Administration should provide states
more funding for enforcement of existing state laws and for increased
consumer education. She said the company would probably oppose any new
federal rules. "We would not be in favor of usurping state
authority," she said. "But we do want to shut down the rogue
operators."


Debby Fry Wilson, legislative affairs director for drugstore.com, said her
firm made a special effort to reach out to policy makers before launching
its Web site last year. "We knew there were going to be illegal
players in the industry and we didn't want policy makers to confuse them
with us," she said.


Drugstore.com and the other big online pharmacies are cooperating with a
White House working group on e-commerce that is looking at online drug
sales. Wilson criticized the Administration for coming forth with its
legislative proposal before the working group completes its deliberations.
"We thought it was premature," she said. The company also fears
that any new laws will merely place "more administrative
burdens" on reputable online pharmacies while not effectively
attacking rogue dealers.


To help with the lobbying effort, CVS.com, drugstore.com, and PlanetRX.com
have all hired lobbying firms. CVS.com is working with Bruce D. Sokler,
the managing partner of the Washington office of Mintz, Levin, Cohn,
Ferris, Glovsky, and Popeo, a Boston-based law firm. PlanetRX has hired
the Dutko Group for lobbying assistance and its public affairs arm, the
DCS Group. Vice Presidents Kimberly M. Spaulding and Robert L. Watson are
handling the account. And drugstore.com has hired Florence W. Prioleau, a
partner at the Washington law firm of Patton Boggs.


Assistant Editor Shawn Zeller contributed to this story.



Marilyn Werber Serafini

National Journal