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Federal Document Clearing House
Congressional Testimony
May 24, 2000, Wednesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 2414 words
HEADLINE:
TESTIMONY May 24, 2000 RON KLINK, REPRESENTATIVE SENATE HEALTH,
EDUCATION, LABOR & PENSIONS GENE THERAPY
BODY:
Statement of the Honorable Ron Klink Enforcing the Laws on Internet
Pharmaceutical Sales: Where are the Feds? May 25, 2000 Thank you Mr. Chairman,
and thank you for having this important hearing. For the past eighteen months,
this Subcommittee has looked into a range of activities related to online
pharmacies, including how they operate; where they get their drugs from; what
potential benefits and threats they pose, and most importantly, who's overseeing
them. Indeed, we know that responsible sites operate online, and offer
beneficial services to the public. But that is not what this hearing is about.
Instead, today's focus will be on what the federal government is doing to
protect consumers from the "rogue" sites, or those sites that offer prescription
drugs in violation of both state and federal law, possibly at the expense of
public health and safety. During our investigation, we have met with a number of
federal authorities and have repeatedly sought detailed information on what is
being done to address this concern' Yet, with significant time having elapsed
since our last online pharmacy hearing, and after numerous document requests and
interviews, I believe we still lack a suitable approach to protecting the
public. Since last July's hearing, the number of sites selling prescription
drugs seems to have increased, not decreased. Moreover, the list of drugs
offered by some sites seems to be growing. For example, in response to a
February 28th, letter I sent to Customs seeking information on the types of
drugs they are finding being sent to the U.S. -- many of which they believe are
linked to Internet sites -- they report the following: Diazepam; various
painkillers with codeine; Xanax; Codigesic; Lorazepam; Fenfieuramine; Rohypnol,
and the list goes on. This agency also reports that they have experienced a
significant increase in the amount of pharmaceuticals being shipped to our
shores. Last year alone, Customs had a more than 400-percent increase over the
previous year. Much of this increase they believe is linked to online
pharmacies. At this pace, I wonder what next year will look like? These
statistics, Mr. Chairman, suggest that the problem is getting worse, not better.
Yet today, still no federal authority can explain who is coordinating this
effort, or what agency or Department is in charge. Why is that, Mr. Chairman? We
all appreciate the complexity of this problem. But with almost a year since our
last hearing, it is not even clear what the two main agencies on this front --
the Department of Justice (DOJ) and the Food and Drug Administration (FDA) --
are accomplishing. Here's an example: In February I wrote FDA Commissioner Hermy
seeking answers to these questions. After months of delay, and then having to
send a second letter demanding answers to my first letter, I finally got a
response on March 23. FDA reported that during the six month period ending at
the end of January 2000, they had spent more than 39,520 hours on this matter.
That's impressive. But when I asked if any prosecutions had occurred as a result
of this effort, here's what they said: 'TDA is not aware that any federal
prosecutions or convictions for Internet pharmacy violations
have occurred at this time." Again, I'll remind you that March 23rd, the date of
that letter, was only two months ago. So I'm confused. Ms is not a new issue or
one we know nothing about. We've all heard the stories of people being able to
obtain drugs online when posing as cats ' dogs, dead people, young children, or
as patients with contra-indicated conditions. What we don't hear is how the
federal government is aggressively attacking this problem. To their credit, many
of the states - with far fewer resources and limited jurisdiction - have
attempted to curtail the activities of some rogue sites. But why aren't we doing
the same at the -federal level? The FDA and DOJ repeatedly tell us, either
"we're working on it," or "it's an active criminal investigation, and therefore
we can't tell you anything." Staff from DOJ said they were "chomping at the bit"
to get these cases referred from FDA (whom they call the "foot soldier" on this
front). FDA tells us that they have referred cases to Justice. But where are the
indictments or prosecutions? Mr. Chairman, buying drugs online can be the health
care equivalent of trick-or-treating in a bad neighborhood. Counterfeit or
adulterated drugs can find their way into the U.S. via rogue sites, with
potentially devastating results. We've seen reports of arrests being made for
smuggling fake Viagra. We've seen accounts of arrests being made for the selling
of fake Xenical, made from only starch and a small amount of an anti- asthmatic
drug. We've even seen reports of fake arnpicillin and AZT made from cassava
starch and anti-mold powder. How prevalent are these bogus drugs? We don't know.
But if we don't get some control over the rogue Internet sites, we may find our
the hard way. Now we've heard talk about self-regulation when it comes to this
Industry. In fact, last July when we had our last hearing on this matter, the
two companies representing legitimate online pharmacies made a commitment to
this Subcommittee that they would have on online pharmacy summit to discuss how
to address these problems. At that time, and even to this day, many believe that
the National Association of Boards of Pharmacy's VIPPS program is the most
suitable approach for doing this. I generally applaud the concept and the
sincerity of that program. But after almost a year, only 5 sites have bothered
to obtain a VIPPS seal. Does this mean that only a tiny fraction are willing to
play by these rules? Should consumers feel safe shopping online when the vast
majority of sites don't have a VIPPS seal? In what other industry would such a
low compliance rate be tolerated? In other words, is that system working? Mr.
Chairman, the U.S. has very strict laws on how drugs can and cannot be dispensed
by doctors and pharmacists. It is a good system that has generally served us
well for decades. Yet many online pharmacies have managed to turn this system on
its head. A patient in state (A) has his prescription written by a mystery
doctor they've never seen or met. Their drugs are then sent by somebody - who
may not even be a licensed pharmacist - from a source that may not even be
located in the U.S. Is that what we envision as sound public health policy? Is
that legal? I'm hard- pressed to believe it is. In the near future, Mr.
Chairman, for some segments of our population, online pharmacies could
significantly affect how drugs are ultimately sold and purchased. So far, we've
seen a generally narrow range of drugs (mostly lifestyle drugs), sold through
the Internet and mostly at similar prices. But in the future, there will be
price competition. Some citizens already head to Mexico and Canada to buy their
drugs, even though that practice is not without risk. What makes us think people
won't buy from cheaper Internet sites that don't require a doctor or pharmacist,
once they begin to offer their drugs? What then? Will the Internet become a
global flea-market for those that can't afford today's high-priced
prescriptions, or for those looking for drugs of abuse? Will we be comfortable
with such system? We need to think about this, because that is what may be on
the horizon. Finally, Mr. Chairman, we still have the question of what role the
drug companies should be playing in this area. For the most part, they've
remained oddly quiet. But should they? After all, it is their products that are
being offered by many of these rogue sites. Are they comfortable with that? What
do we as policy makers think they should be doing and why? Are we prepared to
ask them? At the very least, should these companies post consumer information on
their official promotional sites -- such as at www.viaaa.com, wwwpropecia.com,
www.xenical.com -- warning patients about the potential risks of buying online?
What about providing a link to FDA's website where an in-depth discussion on
this matter can already be found? Because, this could be done almost
immediately, and would cost almost nothing, I'm asking each of the major drug
companies with a promotional site for a drug frequently being sold over the
Internet to consider doing this. Why not? Rather than using these sites only to
promote their drugs, what about using them also to help consumers make safer
decisions when buying online? Mr. Chairman, let me conclude by again thanking
you again for holding this hearing. As you clearly understand, the online
pharmacy world is already and will continue to challenge our public health
policies. While these sites offer many potential benefits, the potential
downside and risks are very real. We must begin to formulate a comprehensive
strategy to this matter before people get hurt. So far, I don't believe that the
federal government has lived up to this task. I once again look forward to
hearing from them as to how they intend to proceed. Thank you.
LOAD-DATE: June 1, 2000, Thursday
