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94–903 PDF 2004

A PRESCRIPTION FOR SAFETY: THE NEED FOR

H.R. 3880, THE INTERNET PHARMACY CONSUMER PROTECTION ACT

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

SECOND SESSION

MARCH 18, 2004

Serial No. 108–169

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

DAN BURTON, Indiana

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

DOUG OSE, California

RON LEWIS, Kentucky

JO ANN DAVIS, Virginia

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

ADAM H. PUTNAM, Florida

EDWARD L. SCHROCK, Virginia

JOHN J. DUNCAN, JR., Tennessee

NATHAN DEAL, Georgia

CANDICE S. MILLER, Michigan

TIM MURPHY, Pennsylvania

MICHAEL R. TURNER, Ohio

JOHN R. CARTER, Texas

MARSHA BLACKBURN, Tennessee

PATRICK J. TIBERI, Ohio

KATHERINE HARRIS, Florida

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. ‘‘DUTCH’’ RUPPERSBERGER, Maryland

ELEANOR HOLMES NORTON, District of

Columbia

JIM COOPER, Tennessee

——— ———

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

(III)

C O N T E N T S

Page

Hearing held on March 18, 2004 ............................................................................ 1

Statement of:

Hubbard, William K., Associate Commissioner for Policy and Planning,

Department of Health and Human Services, accompanied by John M.

Taylor III, Associate Commissioner for Regulatory Affairs, Food and

Drug Administration .................................................................................... 23

Thompson, Dr. James, M.D., president and chief executive officer, Federation of State Medical Boards of the United States; Carmen A. Catizone,

executive director/secretary, National Association of Boards of Pharmacy; Jerry W. Kilgore, attorney general, Commonwealth of Virginia;

Dr. Rebecca J. Patchin, M.D., trustee, American Medical Association;

and John M. Rector, senior vice president of governmental affairs and

general counsel, National Community Pharmacists Association .............. 52

Letters, statements, etc., submitted for the record by:

Catizone, Carmen A., executive director/secretary, National Association

of Boards of Pharmacy, prepared statement of .......................................... 61

Davis, Chairman Tom, a Representative in Congress from the State of

Virginia, prepared statement of ................................................................... 3

Hubbard, William K., Associate Commissioner for Policy and Planning,

Department of Health and Human Services, prepared statement of ....... 25

Kilgore, Jerry W., attorney general, Commonwealth of Virginia, prepared

statement of ................................................................................................... 70

Maloney, Hon. Carolyn B., a Representative in Congress from the State

of New York, prepared statement of ........................................................... 110

Patchin, Dr. Rebecca J., M.D., trustee, American Medical Association,

prepared statement of ................................................................................... 74

Rector, John M., senior vice president of governmental affairs and general counsel, National Community Pharmacists Association, prepared

statement of ................................................................................................... 85

Thompson, Dr. James, M.D., president and chief executive officer, Federation of State Medical Boards of the United States, prepared statement

of ..................................................................................................................... 55

Waxman, Hon. Henry A., a Representative in Congress from the State of

California, information concerning a Web page ................................................ 19

(1)

A PRESCRIPTION FOR SAFETY: THE NEED

FOR H.R. 3880, THE INTERNET PHARMACY

CONSUMER PROTECTION ACT

THURSDAY, MARCH 18, 2004

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:17 a.m., in room

2154, Rayburn House Office Building, Hon. Tom Davis of Virginia

(chairman of the committee) presiding.

Present: Representatives Tom Davis of Virginia, Shays, Souder,

Ose, Schrock, Duncan, Murphy, Turner, Carter, Harris, Waxman,

Towns, Clay, Watson, Van Hollen, and Norton.

Staff present: Melissa Wojciak, staff director; David Marin, deputy staff director and director of communications; Anne Marie

Turner, counsel; Drew Crockett, deputy director of communications;

Teresa Austin, chief clerk; Brien Beattie, deputy clerk; Susie

Schulte, professional staff member; Corinne Zaccagnini, chief information officer; Phil Barnett, minority staff director; Kristin

Amerling, minority deputy chief counsel; Josh Sharfstein, minority

professional staff member; Earley Green, minority chief clerk; and

Jean Gosa, minority assistant clerk.

Chairman TOM DAVIS. Good morning. A quorum being present,

the Committee on Government Reform will come to order.

I’d like to welcome everybody to today’s legislative hearing on

H.R. 3880, the Internet Pharmacy Consumer Protection Act. This

hearing will focus on how to curb, through legislation, the growing

sale of prescription drugs over the Internet without a valid prescription.

Prescription drugs are well regulated in this country by a system

that includes pre-market approval by the FDA, State licensure of

health care practitioners who are allowed to prescribe and State

oversight of pharmacists and pharmacies. However, as noted in

previous committee hearings and recent media reports, the Internet creates an easy environment for illegitimate pharmacy Web

sites to bypass traditional regulations and established safeguards

for the sale of prescription drugs.

I think all of us here today have opened our in-boxes to find dozens of e-mails advertising medications at low cost with no prescriptions required. The risks of this kind of self-medicating can include

adverse reactions from inappropriately prescribed medications,

dangerous drug interactions, use of counterfeit or tainted products

and addiction to habit forming substances.

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Mr. Waxman and I recently introduced H.R. 3880, because too

many people are finding ways to obtain medications online without

valid prescriptions. And regulating those Internet pharmacies can

be a challenge for Federal and State enforcement capabilities. H.R.

3880 amends the Food, Drug and Cosmetic Act to address this

problem in three steps.

First, the bill establishes disclosure standards for Internet pharmacies. These Web sites are required to display certain identifying

information, including the name of the business, pharmacist and

physician associated with the Web site. Second, the bill prohibits

Internet sites from selling or dispensing a prescription drug solely

on the basis of an online questionnaire. Online medical evaluations

don’t meet reasonable standards of care and create risks for the

consumers. And third, the bill provides additional authority for

States to take actions against illegal Internet pharmacies. The bill

allows States attorneys general to file an injunction in Federal

court to shut down a rogue site across the country.

The need for legislation is critical. And I say this as someone

who is normally more than a little hesitant to regulate the Internet

or hinder commerce. The illegal diversion and abuse of prescription

drugs is becoming an increasingly serious problem in this country.

Last March, several of the witnesses who are joining us again

today highlighted this problem in their testimony and asked for

help from Congress. Mr. Waxman and I gave it deliberate consideration and responded with legislation to help protect consumers and

aid Federal and State enforcement and regulatory capabilities.

As we hold this discussion on the legislation today, it’s important

to clarify that H.R. 3880 is intended to tackle domestic Internet

pharmacies that sell drugs without a valid prescription. The bill is

not intended to address international pharmacies that sell drugs at

a low cost to consumers who have a valid prescription from their

U.S. doctors. Although the debate over reimportation is an important one, it’s not the focus of this hearing.

I want to thank our ranking member, Henry Waxman, for his efforts and leadership on this legislation and his commitment to public health. I would also like to thank our witnesses for their participation today, and I look forward to their testimony. I’m happy to

extend a very specific welcome to my good friend, Jerry Kilgore,

who is the Attorney General of my home State of Virginia, who’s

here today representing the National Association of Attorneys General. Jerry, thanks for being with us.

[The prepared statement of Chairman Tom Davis follows:]

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Chairman TOM DAVIS. I will now yield to Mr. Waxman for an

opening statement.

Mr. WAXMAN. I’d like to thank Chairman Davis for holding this

hearing today on how to stop domestic Web sites from selling potentially dangerous medications without a valid prescription. These

Web sites occupy a dark and dangerous corner of the U.S. health

care system. But they are not hidden. A simple e-mail may entice

consumers, even children, to order potentially dangerous drugs prescribed on the basis of a cursory questionnaire by an anonymous

physician.

In fact, just last night, one of my staff members, in preparing for

the hearing today, received an unsolicited e-mail message offering

overnight delivery of Viagra. I have a poster over there that points

out the Web site and that the e-mail was linked to. This Web site

offers many potentially dangerous medications, including some controlled substances. The Web page promises ‘‘FDA approved drugs’’

and states ‘‘one of our U.S. licensed physicians will review your request and issue prescriptions for your medication.’’

I would note that the Web page does not state that a physician

will determine whether this medication is right for you. It does require that the user enter all credit card and shipping information

before any online consultation occurs.

[The information referred to follows:]

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Mr. WAXMAN. The growing number of illegitimate Internet pharmacies has alarmed State medical boards. Yet States which traditionally have regulated the practice of medicine and pharmacy

have been frustrated in their ability to shut these sites down. One

problem is that enforcement efforts are complicated. A Web site operator can be in one State, the pharmacy in a second State and the

prescribing physician in a third State. This may bring three different State standards into play.

A second problem is that even when they are successful, States

typically can only obtain an injunction that keeps an illegitimate

site from selling to residents of that State alone. And a third problem is that some State laws are too vague to allow boards of medicine and pharmacy to quickly crack down on these illegitimate

sites.

When States cannot solve a national problem, it is essential that

the Federal Government step in. In this case, however, the Department of Health and Human Services has been reluctant to venture

into an area traditionally handled by the States absent clear direction from Congress. It’s now time for Congress to provide that clear

direction. Last year, this committee held an investigative hearing

examining domestic Internet pharmacies. At the hearing, individuals representing State and medical pharmacy boards expressed

support for legislation that would create a Federal definition of

valid prescription for the purposes of Internet prescribing.

The Chief of Enforcement at the Food and Drug Administration

testified that such a standard would assist his agency with shutting down illegitimate sites. And the chairman of the Federal

Trade Commission described a successful model in the Federal

Telemarketing Sales Act that permits States to work with the Federal Government to protect consumers.

Since that hearing, we’ve worked together, Chairman Davis and

I, to craft a narrow, but effective legislative remedy. Our bill, H.R.

3880, creates a single national standard for valid prescription for

Internet prescribing, by barring Web sites from arranging prescriptions from doctors who have never seen the patients. It also provides that Internet pharmacies make basic disclosure of information to consumers, and it allows State attorneys general to obtain

nationwide injunctions against illegal sites, avoiding the need for

cumbersome State by State enforcement.

Our philosophy with this bill is that less is more. We have aimed

to define the minimum Federal standard necessary to accomplish

our goal, and we have encouraged enforcement by the States, the

traditional regulators of medicine and pharmacy. Our bill does not

affect the separate question of reimportation of prescription drugs,

and it would not alter the practice of telemedicine.

I look forward to hearing from the distinguished witnesses today

and to working with Chairman Davis and all the members of this

committee to improve this bill as necessary and move it through

the Congress. This is a good example of the legislative process at

its finest. After hearing from the witnesses at our first hearing on

the matter, we looked at what they had to say, we heard what they

suggested and we came up with a proposal. Now today we’ll hear

reactions to these proposals. Those reactions and the input help us

make sure that we’re working together on a bipartisan basis to

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make the bill as good as it possibly can be to protect the public interests.

I thank the chairman for setting the tone and working in this

way so that we can accomplish something that’s important for the

American people.

Chairman TOM DAVIS. Thank you, Mr. Waxman.

Do any other members wish to make statements? The gentlelady

from the District of Columbia.

Ms. NORTON. Mr. Chairman, I appreciate the way you and Ranking Member Waxman have worked together to try to deal with this

relatively new phenomenon. It is also a new phenomenon in our society that prescription drugs are advertised on the media. In fact,

some of the advertisements are truly laughable. After trying to entice you to, in this country I suppose, go to your doctor and get a

prescription for XYZ drug, then they list all the things it will do

to hurt you. I guess that’s because of regulations of the FDA. So

they become fodder for the late night talk shows, all these miracle

drugs are advertised along with all the things they could do to

harm you, so there will not be liability, in case you don’t understand that these drugs have both good and bad effects.

But of course, if you go to your doctor, you’re going to find that

out, and you’re going to have a professional that makes that judgment and advises you accordingly. But the Internet has opened up

a straight line path between the patient and somebody somewhere

who in fact will provide this drug that perhaps you have seen on

television that you think is exactly what you need to do what you

want, without any expert intervention. This, I cannot, first of all,

it amazes me that this has gone on this long without some action

at the Federal level. I understand that States have tried to do

something about this. But this of course cries out for ICC, for the

commerce clause intervention of the Federal Government.

I say that I’m surprised that no catastrophe has occurred with

people ordering these drugs. I’m sure there has. If problems have

occurred, I can’t imagine where the liability would lie, or if in fact

you would find somebody to sue and sue successfully, especially

since this goes on across international boundaries. This has already

gone on much too long. We have no way of knowing, no way of

knowing how many people have been hurt. We do know this is a

very enticing temptation, particularly when the drugs are advertised on legitimate television and you can eliminate some of the difficulties, especially with the cost of health care, and going to a doctor, by going straight to one of these Web sites and perhaps doing

yourself great harm.

Prescription drugs are the true miracle medicine for today, because they do so much good, I think the time has come to make

sure we don’t besmirch what these drugs can do by allowing this

matter to hang out there unattended. I thank you very much again,

Mr. Chairman, for this hearing.

Chairman TOM DAVIS. Thank you. Any other statements?

If not, we have our first panel. We have Mr. William Hubbard,

who is here testifying on behalf of the Food and Drug Administration. Mr. Hubbard is the Associate Commissioner for Policy and

Planning. He is accompanied by Mr. John M. Taylor, III, the AssoVerDate 11-MAY-2000 11:09 Aug 19, 2004 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 D:\DOCS\94903.TXT HGOVREF1 PsN: HGOVREF1
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ciate Commissioner for Regulatory Affairs. Mr. Taylor will be available to respond to questions posed by Members.

It is the policy of this Committee to swear in all witnesses before

they testify. Would you stand with me and raise your right hands?

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you.

Mr. Hubbard, your entire statement is a part of the record. What

we would like you to do is try to keep it to 5 minutes. We have

a light in front of you, when it turns orange, it means 4 minutes

are up and when it turns red 5 are up, and try to move to summary, because our questions are based on your entire testimony.

We welcome you and thank you for being with us. You too, Mr.

Taylor.

STATEMENT OF WILLIAM K. HUBBARD, ASSOCIATE COMMISSIONER FOR POLICY AND PLANNING, DEPARTMENT OF

HEALTH AND HUMAN SERVICES, ACCOMPANIED BY JOHN M.

TAYLOR III, ASSOCIATE COMMISSIONER FOR REGULATORY

AFFAIRS, FOOD AND DRUG ADMINISTRATION

Mr. HUBBARD. Thank you, Mr. Chairman. As you say, I do have

a written testimony.

I will just make a few brief remarks. We thank the committee

for holding this hearing. We believe you are recognizing a significant public health threat from unregulated Internet sites. The

Internet sales of drugs are a wonderful tool for pharmacists and

patients and physicians to use. However, only when they’re properly operated and regulated, and as you are pointing out, many of

these are not.

The public health threat, we believe, is real when patients unknowingly purchase these drugs from unknown Web sites. And the

disclosure concept that you have recognized we believe is an important one.

We appreciate that the committee is trying to identify some solutions to this problem, who and where these sites are, whether they

are licensed, whether they use one of these dubious questionnaires.

The concept of the intermediary is clearly very important in the

prescribing of drugs, and these sites often do skirt that.

FDA often monitors the Internet, and one of the sites that we’ve

just noticed very recently I’d like to point out to the committee, if

I could ask the clerk to bring it up to the Chair. This site is quite

interesting, because we believe it is emblematic of some of the

things that your bill is attempting to do and the committee is recognizing.

As speakers on the committee pointed out, many Americans get

e-mails offering to sell prescription drugs. This particular site, and

there’s a poster of it over here against the wall, offers to sell generic drugs. These particular generic drugs or alleged generic drugs

do not have generic versions. So we decided to investigate that a

bit more.

So we did a check on the location of the actual Internet site and

found that it was in China, in Xiandong Province, China. We

thought they might be selling Chinese counterfeits. So we actually

made a purchase. When the drug arrived, as you’ll see on the envelope there, it has a return address of Miami, FL. Yet the postmark,

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you may notice, is Dallas, TX. Then there’s a return address, if

someone needs to reorder, in the package that suggests that the

person should contact someone in the country of Belize. Then

there’s an 800 number which we called, and the person there said

they were located in the United States. When we called back a second time, they said they were in Belize.

We ordered three drugs, Ambien, a controlled substance, it’s a

sleep aid, Viagra and Lipitor. And we noted on the so-called online

questionnaire that we were taking erythromycin. Erythromycin is

a drug that’s contraindicated for Lipitor. So here you have the kind

of situation the committee is pointing out, you’ve got a so-called

questionnaire in which the patient has a consultation with some

potential physician in another country, and you’ve got a lack of disclosure, and in fact, this site has so many convoluted potential

sources that we don’t know where it is.

So the disclosure concept that is embodied in the bill we believe

would address these sorts of issues of the sites not being where

anyone knows about, and allowing people to buy or get a drug that

has no true prescription with it, there’s not really a doctor at the

other end that sees the patient, diagnoses the patient and makes

a rational prescription for the patient.

So with that, Mr. Taylor and I will be happy to take questions.

[The prepared statement of Mr. Hubbard follows:]

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Chairman TOM DAVIS. Thank you very much. I apologize, the

vice president was on the phone and I had to have Ms. Harris ably

take the Chair while I was there. I apologize for leaving in the middle of your testimony. I did read it last night, though.

Let me start the questioning. Historically, States have been the

primary enforcement authority with respect to the practice of medicine and the dispensing of prescription drugs. How do you find that

appropriate balance? And of course, the Internet raises a whole

new paradigm for us in terms of how you do this, because it’s so

ubiquitous.

Mr. HUBBARD. And many people have pointed out, because the

Internet crosses State lines, it’s more difficult for States to enforce

in these kinds of cases you have pointed out. Congress has given

FDA the authority to regulate the practice of medicine in only one

case that I’m familiar with. And the FDA itself has been reluctant

to step into the regulation of the practice of medicine, which has

been a State responsibility. Here you are identifying the potential

need, perhaps, to take one more step into that with the definition

of a valid prescription. And we certainly understand your thinking

in doing so.

Chairman TOM DAVIS. Both the AMA and the FSMB have guidelines that stipulate an appropriate medical relationship between

the patient and physician must exist before a prescription is written and dispensed. AMA and the FSMB define this relationship to

include a documented patient evaluation, including medical history

and a physical examination.

Do you agree these recommendations are also consistent with the

language in H.R. 3880?

Mr. HUBBARD. I believe they are, Mr. Chairman.

Chairman TOM DAVIS. Mr. Taylor, do you agree with that, too?

Mr. TAYLOR. Yes.

Chairman TOM DAVIS. Mr. Taylor, at the hearing last March, you

stated that a Federal standard for what constitutes a valid prescription would aid enforcement capabilities. Are you still of that

opinion?

Mr. TAYLOR. I did acknowledge that. To put it in context, I think

what I said last year was, a part of the complementary enforcement role of the States and Federal Government, we were often relying upon the State medical boards or boards of pharmacy to inform us what the proper standard of medical care is within a particular State. So when we’re building a case and there are differences from State to State, that raises some challenges, absolutely.

Chairman TOM DAVIS. FDA has indicated, in your testimony,

that it has the legal authority to take action against the sale of dispensing a prescription drug without a valid prescription. How often

has the FDA used this authority to take action against rogue Internet pharmacy sites?

Mr. TAYLOR. I can give you a recent example. Yesterday, we announced that we had brought indictment against an Internet pharmacy site, where indeed one of the charges was the fact that the

product was being dispensed in a manner that was outside the

proper standard of care, standard of medical care and the standard

of pharmacy in that particular State.

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It’s often an element of our criminal cases, what we will do is

consult with the States, figure out what the standard is within that

State and make that one of the charges. What we’ve seen in many

cases, especially two recent criminal cases, is that there often have

been attempts by those who have been indicted to either hide the

identity of those physicians that are supposed to be giving proper

care, or misrepresenting the fact that they are licensed within a

State, when in actuality they are not.

So it’s often a component of the cases that we bring.

Mr. HUBBARD. And Mr. Chairman, while we can do in some

States that have explicit laws, there are many, many States, in fact

the majority of States, where the State law does not explicitly define it in a way that FDA can use its authority.

Chairman TOM DAVIS. Mr. Taylor, also in the March hearing,

you noted that you couldn’t name a single State that qualifies the

use of an online questionnaire as a legitimate or appropriate medical relationship. Do you agree that online medical questionnaires

don’t constitute an adequate or appropriate medical relationship?

Mr. TAYLOR. Let me refine that answer. I’m aware of approximately 27 States that generally disallow Internet prescribing. I

think 7 of those States do so by explicit statute, I think 12 do so

based on medical board policy, and another 8 do so based on medical board rulings. There are another 13 States that have chosen to

make a determination that Internet prescribing is impermissible.

So now there are approximately 40 States that have taken a position that there is some means as to what constitutes proper Internet prescribing, and an online questionnaire falls outside that

arena. Mr. Chairman, one of the things that’s changed in the 5

years that we’ve been dealing with the Internet is the fact that

both on the Federal Government level and the State government

level, our statutes did not, quite frankly did not contemplate this

type of practice.

As time has gone by, the States have taken steps to address it

expressly through the medical boards and through their boards of

pharmacy. That’s why today we have 40 States that have taken

some stance. That has obviously enhanced our enforcement efforts

on the Federal level, too. So things have changed a little since last

year.

Chairman TOM DAVIS. AMA’s testimony today highlights the

need for something to be done at the Federal level to address the

myriad problems associated with the illegal use of Internet pharmacies. Do you agree with them?

Mr. TAYLOR. Well, I mean, traditionally the regulation of, or

what constitutes a proper medical standard or what constitutes a

proper or valid prescription is something that has resided at the

State level. I think to the extent that there is going to be any

change in that position, it needs to be done very carefully.

Chairman TOM DAVIS. OK. Thank you very much.

Mr. Waxman.

Mr. WAXMAN. Thank you, Mr. Chairman.

Mr. Hubbard, in your written testimony today, you expressed

FDA’s concern about the proliferation of sites that substitute a simple online questionnaire for a face to face examination and patient

supervision by a health care practitioner. Let’s assume for the moVerDate 11-MAY-2000 11:09 Aug 19, 2004 Jkt 000000 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 D:\DOCS\94903.TXT HGOVREF1 PsN: HGOVREF1
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ment that some of these Web sites employ licensed physicians to

write the prescription on the basis of the questionnaire.

When assessing whether these prescriptions are valid, does FDA

rely on a single Federal definition or defer to the States?

Mr. HUBBARD. We defer to the States.

Mr. WAXMAN. Are all State definitions alike?

Mr. HUBBARD. No, they are not, Mr. Waxman.

Mr. WAXMAN. Do the varying definitions complicate enforcement

actions?

Mr. HUBBARD. No question.

Mr. WAXMAN. H.R. 3880 would solve this problem by creating a

single national standard for what is a valid prescription related to

Internet pharmacies. We’re going to hear from the Virginia State

Attorney General on behalf of the National Association of Attorneys

General and the Federation of State Medical Boards and the National Association of Board of Pharmacy are going to endorse such

a standard.

Why do you think these key State organizations support having

a single Federal standard for prescription related to Internet prescribing?

Mr. HUBBARD. When the Internet emerged as a tool of this nature, drug prescribing became obvious at that time. I believe the

States thought they could, using their existing authority over physicians and pharmacies, appropriately regulate these businesses.

They realized fairly quickly, I think by the year 2000, that because these sites would be located in one State but the patient in

another that they would be unable to do so, and you needed, in

their view, and I believe they will express that for themselves, as

I understand it, they expressed the view that you needed some sort

of a more uniform national standard. I believe they are supportive

of that today.

Mr. WAXMAN. So it seems that a single national standard is

needed to address these rogue Web sites?

Mr. HUBBARD. It’s certainly their opinion.

Mr. WAXMAN. Our legislation provides this standard, while maintaining the key enforcement role for the States, as you well know.

Thank you very much for your testimony, both of you, and thank

you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much. Mr. Shays.

Mr. SHAYS. I’ll pass, thank you, Mr. Chairman.

Chairman TOM DAVIS. Any other questions on this side? The gentleman from Tennessee.

Mr. DUNCAN. Mr. Hubbard, as the chairman pointed out in his

first question, the primary enforcement role for prescribing drugs

is up to the States. But of course, the Internet does not recognize

State lines or moves across State lines, so it’s a difficult thing for

States to enforce this totally.

I’m just curious, how fast are these Internet prescriptions growing? Do we have any estimate of that? All the articles you read,

they say it’s growing very fast. But I just wondered if you have any

statistics of how many prescriptions are being issued over the

Internet now.

Mr. HUBBARD. There’s no certainty here. There are clearly estimates made by various groups. I think the National Association of

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Boards of Pharmacy has recognized at least 200. There are many

more foreign sites. We did a computer search just last week for one

particular set from one country, and this is the list. There’s well

over 1,000 here. And that’s just one locality. So worldwide, there

may be——

Mr. DUNCAN. Is that 1,000 prescriptions?

Mr. HUBBARD. It’s 1,000 different Web sites offering to sell drugs

in the kinds of ways that the committee is recognizing.

Mr. DUNCAN. I see. And do you know of instances where children

have been getting these drugs over the Internet? Have you heard

about that?

Mr. HUBBARD. Certainly there are drugs that children used being

prescribed. There’s a wide, wide range of drugs being prescribed.

Some sites limit themselves to just a few lifestyle drugs like

Viagra, but many sites sell a list of hundreds of different drugs.

Mr. DUNCAN. Have you been getting reports of people who have

been injured or been hurt or made sick or have been ripped off by

these prescriptions?

Mr. HUBBARD. We do have reports. Unfortunately, they are relatively sporadic. They depend on a patient who’s injured reporting

to us. There’s no good system for tracking some of these drugs that

are sold illegally. Because the medical system is designed to track

systems that are properly prescribed and dispensed by licensed

pharmacies in the United States.

Mr. DUNCAN. I know it’s difficult, but have you had 100 instances

or 1,000?

Mr. TAYLOR. I can’t give you a number, but I can give you a tangible example. Last summer, and the agency is continuing to investigate this, but last summer we had to assist in the recalling of

over 200,000 bottles of Lipitor, because we discovered that it had

been counterfeit. Obviously the benefit——

Mr. DUNCAN. Where was that?

Mr. TAYLOR. I’m sorry?

Mr. DUNCAN. Where was that you recalled——

Mr. TAYLOR. Actually, by the time the recall was finished, the

counterfeit Lipitor had spread throughout the country. In some

cases it was available through a brick and mortar pharmacy, but

in other cases it was available over the Internet. The reason I used

it as an example is because obviously the benefit of Lipitor is its

cholesterol lowering properties. And one of the——

Mr. DUNCAN. Was that Lipitor being sold by one Internet site or

many?

Mr. TAYLOR. It’s not clear how many sites it was sold over, but

we did get consumer complaints suggesting that it was at least sold

over two. What happened is when we put out the original talk

paper warning the public about the fact that we had discovered

this product, we began to get reports from people. A couple of people reported purchasing it over the Internet.

So I don’t know how many Internet sites it was available at, but

that’s a tangible situation where someone was purchasing a product thinking they were getting cholesterol lowering properties, and

because of the nature of the product, not only were they not necessarily getting the cholesterol lowering properties, you could argue

44

that indeed they were being ripped off, because they were paying

for something that they didn’t actually get.

Mr. HUBBARD. Let me give you an example, Mr. Duncan. I’ve got

one site here, there are 400 different Web sites, when we checked

them, they are all the same business. The same individual runs

them, from a small New England town. But they all have different

names, and they’re targeted at citizens in different countries, Houston, Phoenix, wherever. So the citizen thinks that’s a local business

in his hometown selling legal American drugs. In fact, it’s one business in New England saying 400 times in 400 cities, we’re legitimate, we’re legal and we’ll give you a drug if you’ll fill out a questionnaire.

Mr. DUNCAN. OK, well, thank you very much.

Mr. HUBBARD. You’re welcome.

Chairman TOM DAVIS. Thank you very much. Ms. Watson, any

questions?

Ms. WATSON. I’m waiting on a copy of the bill, Mr. Chairman.

But in the bill, this is a question to the Chair, does it require a

legitimate prescription from the doctor and how is that checked

out? You send this, if there’s a requirement by the company, you

send that in, how do they check it out to be sure it’s valid?

Chairman TOM DAVIS. A valid prescription is required to exist.

But we go further to define an adequate medical relationship, so

that the person who is prescribing it has done an appropriate examination and taken the history and has had a meeting with the

person, as opposed to calling up and a doctor just writing a prescription because you’re willing to pay money. That’s what’s critical

in these cases. A lot of these Web sites have people who will sign

prescriptions but they know nothing about the people who are taking the drugs, what they’re interacting with, and that’s where the

danger occurs.

Ms. WATSON. Let me ask Mr. Hubbard, certainly each State differs from the other. What would be the standard positions that you

would like to see in a piece of legislation that would be able to

monitor the abuse of the Internet prescriptions?

Mr. HUBBARD. As Chairman Davis said, FDA has a requirement

that there be a valid prescription. That’s Federal law.

Ms. WATSON. Yes.

Mr. HUBBARD. But then FDA relies upon each State to determine

whether a given prescription in that State is valid.

Ms. WATSON. Who’s the watchdog?

Mr. HUBBARD. Well, in the case of prescriptions, it’s actually the

State medical boards and pharmacy boards, not the FDA. Federal

law does have a requirement that there be a valid prescription, but

each State then determines what that is.

Ms. WATSON. Question to the Chair, I haven’t read the legislation yet. But is there a requirement that each State indicate who

the watchdog agency is and what they watch for?

Mr. HUBBARD. I believe it’s very clear, Ms. Watson, that the

State pharmacy and medical boards have that responsibility. They

accept that responsibility. But what they’re saying is that they

can’t utilize their law if the Web site is in another State, because

they can’t prosecute across State lines.

45

Ms. WATSON. So how do we at the Federal level get to that issue?

That’s the crux of this question, and maybe this is to the author.

Chairman TOM DAVIS. What happens in this case is we define an

appropriate medical relationship. That’s where this stuff goes afoul.

They can produce a doctor’s note on this, a doctor’s prescription,

but there’s no relationship. It’s almost like an auto pen. There is

no appropriate medical relationship, as we define the appropriate

medical relationship. It would be up to the State and their enforcement actions to go there, and the burden would be on the people

who are dispensing this to prove they had the relationship, which

of course they don’t, in many of these cases.

Ms. WATSON. Who oversees that, the FDA? Or the State attorney

general?

Mr. TAYLOR. Just to give you an example, there have certainly

been instances where more than one State has recognized behavior

that they deemed to be problematic. What the States have been

able to do is bring some type of action that is confined to their

State boundaries. But what we’ve also tried to do is work closely

with them so that we, the Federal Government, could bring a case

that is more global in nature and is complementary to the case that

the State is bringing, so there’s a more comprehensive approach to

dealing with problematic conduct that might be going beyond State

lines.

So there is a way to do it.

Chairman TOM DAVIS. Let me try to help you. Our bill allows,

the new enforcement authority that we give in this case is modeled

on the Federal Telemarketing Sales Act. So we have an appropriate

Federal model on this. That allows the State attorney general to

shut down a rogue site across the country rather than only bar

sales to customers or consumers in his or her State.

Ms. WATSON. If the Internet shows a location down in Central

America for controlled drugs, who then is—I see somebody shaking

their head—who then is in charge of overseeing that on the Internet?

Mr. TAYLOR. For controlled substances the Drug Enforcement

Administration has primarily jurisdiction over controlled substances. However, the FDA and the States will often work, again

with DEA, to help bring cases if we determine that those products

that are being marketed through the Web site that’s listed in Central America are actually making their way to the United States.

Ms. WATSON. May I ask who determines that? How is it triggered? How does the process start?

Mr. TAYLOR. Usually it’s triggered based on the working relationships that we’ve established over the years. We’ve been at this for

about 4 or 5 years. We recognized fairly early on that none of us

quite frankly had either the resources or the expertise to do it ourselves. So over the last 4 or 5 years, we’ve tried to work closely

with both our Federal and State partners that we could work together on a real time basis to address these situations when they

come to our attention.

So it’s really through our partnerships and working relationships. And over time, they’ve proved to be quite successful. So

that’s usually how it’s done.

46

Chairman TOM DAVIS. Thank you. Time has expired. Thank you

very much.

The gentleman from Connecticut, Mr. Shays.

Mr. SHAYS. Thank you, Mr. Chairman.

Mr. Chairman, thank you and Mr. Waxman for highlighting this

issue, thank you for having this hearing, thank you for coming forward with the legislation that we can consider. In my earlier life

I used to chair the subcommittee of this full committee that

oversaw the FDA. And I appreciate so much what FDA has to contend with.

At the same time, I do have some issues that I want to ask. We

talk about the questionnaire that has to be filled out for the Web

site. I sent a questionnaire to my constituents. And I had one

where I gave a statement, I said strongly agree, somewhat agree,

no opinion, somewhat disagree, strongly disagree. This was the

statement. Americans should be able to import less costly FDA approved prescription drugs from Canada.

I had an intuitive sense that they would probably agree; 62.7

percent strongly agree, 20.4 percent agree, 83.1 percent of my constituents believe that they should be able to import less costly FDA

approved prescription drugs from Canada. Does that statistic surprise you?

Mr. HUBBARD. Not at all.

Ms. SHAYS. The issue is, that’s illegal right now?

Mr. HUBBARD. Absolutely.

Ms. SHAYS. Constituents are doing it, correct?

Mr. HUBBARD. Absolutely.

Mr. SHAYS. I’m told the drug companies have basically exported

to Canada or allowed to come into Canada basically seven times

what Canada consumes, and it’s a growing market. How would you

begin to even reign in this illegal activity in Canada? Not that I

even know if I want you to, frankly. I’m having to deal with it.

Mr. HUBBARD. We cannot, under current law. The current law

was established for FDA to inspect a very large volume of an imported drug, say, millions of pills that Pfizer might bring in from

a plant in Ireland. And that process worked very well. But when

individuals buy these small 60 or 90 day supplies, and it comes in

huge quantities to the mail facilities in this country, neither the

Postal Service nor Customs nor the DEA nor FDA can in any rational way look at all those products and make any judgments

about whether they’re good or not.

Mr. SHAYS. Who’s breaking the law? Is Canada breaking the law

in exporting them, or are my constituents breaking the law when

they buy them?

Mr. HUBBARD. It may be a violation of Canadian law, but that

is would be for them to determine. The drugs themselves are clearly illegal. FDA, though, has never taken enforcement action——

Mr. SHAYS. But listen to my question. My question is, who’s

breaking the law in the United States?

Mr. HUBBARD. On some technical level you could argue that the

patient is breaking the law by buying those drugs, but the FDA

has never attempted to punish a patient for buying drugs.

Mr. SHAYS. So the reality is, whatever we do, we still have that

issue out there?

47

Mr. HUBBARD. The implication issue, as the chairman said at the

outset, will still be there.

Mr. SHAYS. And we need to bring some census, both here and

overseas. But what I’m wrestling with is, I happen to believe that

people should be able to import drugs if they’re FDA approved. And

what I also wonder about is, these aren’t drugs necessarily made

in the United States then sent to Canada, they’re sometimes made

elsewhere and sent to Canada, just as they would be sent to the

United States.

Tell me the logic of why my constituents shouldn’t be allowed to

buy the same drug, and if they can buy it overseas for less, why

they shouldn’t be able to?

Mr. HUBBARD. Because, Mr. Shays, the assumption people make

that those drugs are all U.S. made, high quality drugs, just coming

back, is wrong in our view.

Mr. SHAYS. Does it matter if it’s U.S. made? But they make an

assumption that the drugs they buy here are U.S. made, and they

are. So I don’t get your point.

Mr. HUBBARD. If you buy a drug here, it’s been made in an FDA

inspected facility under very strict FDA manufacturing controls.

These foreign drugs in many cases do not meet those criteria. So

that’s the problem. The patient can’t make a determination whether they’re getting that U.S. made drug you describe or the other

drug.

Mr. SHAYS. Do we have statistics that tell us that the drugs

they’re buying from Canada are mostly not FDA approved?

Mr. HUBBARD. Mr. Taylor can describe a process of screening

these shipments. He’s done two of those recently that found the

vast majority of these actual shipments from Canada are not FDA

approved drugs.

Mr. SHAYS. OK. So just tell me the statistics. I don’t need to

know the process.

Mr. TAYLOR. Sir, I’m not sure we have good statistics. We’ve tried

to determine the percentage, as have others. But the bottom line

is that we do believe that as demand here increases, or at least our

fear is that as demand here in the United States increases, that

the Canadian pharmacies that we now see will get their product

from sources that are less reputable than the sources——

Mr. SHAYS. But you’re not listening to my question. My question

is, do you have statistics that say that the vast majority of the

drugs, you’re saying it, but you’re not giving——

Mr. HUBBARD. We have sampling statistics, yes.

Mr. SHAYS. What is the statistic, that 90 percent, 50 percent, 20

percent, 80 percent, what is it?

Mr. HUBBARD. Well, it’s certainly over 90——

Mr. SHAYS. No, no, wait, wait——

Mr. TAYLOR. What the blitz showed was that 70 to 90 percent of

the products that were being imported were unapproved. We do not

have data——

Mr. SHAYS. Unapproved means not FDA approved?

Mr. TAYLOR. Correct. But we do not have data that tells us how

much of the product is manufactured in Canada versus manufactured in England versus manufactured in Asia.

48

Mr. SHAYS. Let me just finish this by just making a comment.

I know my light is on. This is hugely important, that people buy

drugs actually need the drugs they buy and have been shown by

a medical professional to need them. My only point is that we’re

saying this isn’t illegal, this is illegal from the United States, but

we’re not enforcing it. And you have ambivalence in Congress on

this law. This is a huge, gigantic issue that’s just only going to get

bigger.

With all due respect to your work, we don’t have statistics. We’re

making claims that we can’t back up with statistics.

Mr. TAYLOR. May I respond, sir?

Mr. SHAYS. Sure.

Mr. TAYLOR. We do not have statistics, but we certainly have

tangible information. For example, your first question relating to

what you should tell your constituents or why your constituents

should be concerned about purchasing products over the Internet,

3 weeks ago, and I know this isn’t about the——

Mr. SHAYS. Can I tell you this? I don’t want to keep—my red

light is on. But your bottom line is you don’t have statistics right

now. If I have a second round I would be happy to get more information.

Chairman TOM DAVIS. Let me just note again, I mean, this is an

important issue. But the bill really tackles domestic Internet pharmacies. We don’t really go after the other.

Mr. TAYLOR. That’s right. My point was that someone purchased

contraceptive patches over an Internet site that she thought was

a U.S. Internet site. In actuality, she received contraceptive patches that had no active ingredient in them. By the time we completed—and we’re not done with our criminal investigation yet—

but by the time we completed that investigation, sir, the origin of

those patches turned out to be India. We had to actually track

through about five or six different sites to determine the origin of

the product.

So my only point is that the reason why people need to be concerned is that even though it appears that you’re getting an FDA

approved product, we do have tangible examples of where people

have not received what they wished or hoped that they had purchased. And it was a consumer complaint by this particular consumer that led us to the discovery. What we did is we warned consumers to beware of other products purchased on these sites.

We were not saying that all sites are bad, but we had tangible

proof that these were problematic sites and we warned the public

that they needed to be careful and talk and consult with their

health care practitioner when making a decision whether or not to

purchase over some of these sites.

Chairman TOM DAVIS. Thank you.

Let me just ask if any other Members have questions for this

panel. Mr. Murphy.

Mr. MURPHY. Thank you, Mr. Chairman. I also compliment you

and Mr. Waxman for moving forward on this important legislation.

This is rather urgent, because it is such a major issue with regard

to abuse and use of the system for doing this.

I want to ask a couple of things. First of all, the physicians who

are involved with prescribing these drugs at the other end of the

49

Web site, in some cases they may not be physicians at all, and in

some cases, from other State or other countries, they’re not open

to any liability at all if they mis-prescribe, if they do not take an

accurate history, they’re not open to any liability, am I correct in

that?

Mr. HUBBARD. The next panel may be better set to answer that

question. But certainly we have pointed out that liability concerns

must exist here in these cases, because you’ve got people doing

things that are either outside the law or not proper medical practice.

Mr. TAYLOR. And sir, if we can determine that those physicians

are a part of a criminal conspiracy, because in some cases, the physicians have an agreement with the Internet pharmacy that’s supplying those products, we do include them as part of the defendants

in our criminal cases. So they do incur some criminal liability.

Mr. MURPHY. Another question I have with regard to FDA, is

there any requirement for pharmaceutical manufacturers to only

sell prescription medication to legitimate distributors who will ascribe to some sort of other laws or code of ethics with regard to how

those medications will be distributed?

Mr. HUBBARD. Well, in fact, we’ve been working with the wholesalers and distributors and manufacturers this year to set up

standards by which wholesalers will assure, and manufacturers can

assure that they are selling to legitimate wholesalers and that the

proper questions get asked about where the drug came from. There

are some instances in which wholesalers will buy from somewhat

fly by night sellers of drugs who offer a deep discount. And that

is a way for counterfeit drugs to get into the system.

Mr. MURPHY. There is something I want to bring to the committee’s attention, too, another important aspect of this, and that has

to do with, even when a physician has face to face contact with a

patient, particularly the elderly, there was a recent CDC study, the

National Ambulatory Medical Care Survey did a study in which

they reported that at least one drug considered inappropriate by

experts was prescribed at 7.8 percent of elderly patient visits.

That’s some 16 million visits a year. This one drug classified as

never or rarely appropriate was prescribed nearly 4 percent of the

time.

There’s a massive amount of medication errors that occur, even

when a physician is face to face with an elderly patient. When I

look at the charts here of what is available online, particularly

some of the anti-depression and pain relief drugs that may have

side effects, such as dizziness, etc., nothing is more fearful to an

elderly person than falling down, having a hip injury, being hospitalized and having subsequent problems with that.

I cannot possibly imagine a scenario by which someone would be

self-prescribing these things in any sort of a way that’s actually

good for their health. I understand situations in which a patient is

seeing a physician and has received a prescription from a physician, a legitimate physician in their area. But I do worry about people self-prescribing, and that is a huge concern. Relatives may say,

let’s help Mom or let’s help Grandma. Here is something that we

know helped someone else, let’s pursue that.

50

The consequences can be extremely harmful and deadly. Some 1

in 8 emergency room visits in this country are medication errors;

1 in 12 hospital admissions are related to medication errors. And

those are when patients are seeing physicians.

So moving forward on legislation such as this is extremely important. However, under the circumstances where a person is seeing

a physician it’s helpful. But under the circumstances where someone is still trying to self-prescribe or obtain drugs in unscrupulous

manners and use that, I’m very, very worried that there’s almost

nothing we can do to prevent that. Am I correct?

Mr. HUBBARD. You’re absolutely correct, Mr. Murphy. Someone

could say on one of these questionnaires, I have hypertension, high

blood pressure, when in fact they have hypotension, low blood pressure. And they could order exactly the wrong drug, because the patient is making that decision without the doctor’s involvement. Because we don’t believe in many cases there is a doctor at the other

end, and they certainly don’t seem to be asking the right questions

of the patient, and they’re certainly not meeting and seeing the patient and checking their blood pressure and all that.

So you’re absolutely right. This is a problem that needs to be

fixed.

Mr. MURPHY. On these, do they know the other medication the

patient may be on?

Mr. HUBBARD. It purports to ask some of those questions——

Mr. MURPHY. But they may not know them all, because patients

themselves may not know.

Mr. HUBBARD. One of the things we did here, we ordered a drug

that is contraindicated to be taken with a different drug called

erythromycin. So we said that on the questionnaire, we said, I’m

taking erythromycin, and we ordered Lipitor. They sent the Lipitor

anyway.

So it appears they didn’t even bother to read the questionnaire.

It appears in some cases these questionnaires are merely there as

a facade anyway.

Mr. TAYLOR. And just to add to that, I think we need to keep in

mind there are also different types of questionnaires. There are

some questionnaires that are basically all filled in for you, all you

have to do is insert your name and your address, and that’s it.

There are other questionnaires that ostensibly pretend to get all

the relevant information, but at the end of the day, as you noted,

because there isn’t really the proper health care practitioner-patient interaction, you’re absolutely right, that there might be critical information that should be gleaned from the patient that is not

done. That puts the patient at potential harm.

Mr. MURPHY. My hope is we continue on with these hearings and

move forward with this legislation, that Americans will pay attention to the idea that seeing a physician face to face has some room

for medication error there alone. Self-prescribing and going to sites

that are illegitimate is downright dangerous and deadly, and people have to avoid those sorts of sites, because that is something

that is going to end up killing and harming a lot of Americans.

Thank you.

Mr. HUBBARD. We agree, Mr. Murphy.

51

Chairman TOM DAVIS. Thank you. Are there any other members—Mr. Carter, any questions? No other questions. I don’t have

any others. Mr. Shays, did you want to ask a followup?

Mr. SHAYS. If someone is sent a drug that they didn’t have a prescription for and they were to become ill or die, could the pharmaceutical or the Internet organization be found guilty?

Chairman TOM DAVIS. If you can find them.

Mr. HUBBARD. I think you’re talking about a tort liability question. We certainly have raised those questions in the case of some

businesses that are promoting these. It’s not really an FDA question. But one would assume that there would be some liability

there.

Mr. SHAYS. I’m struck by the fact that this is so stunning that

I didn’t know, I mean, not that many of us didn’t know, but I’m

astounded that I didn’t know that you could get something without

having some kind of prescription. It tells me frankly that you all

have a responsibility as well. The mere fact that I asked you a

question about that issue, it would seem to me that FDA needs to

be much more proactive.

And they’re going to have to, I think, sort out, rather than saying, you know, what’s happening in Canada is illegal, but it’s still

going to continue. I happen to want to make it legal. I don’t like

people breaking the law, but I want to make it legal in a way that

works. But I want to do what the chairman wants to do. And I just

appreciate that he’s made this an issue that we need to be more

aware of.

But I’m saying as well, I think you all have a responsibility to

be a lot more proactive on this.

Mr. HUBBARD. Fair enough, sir.

Chairman TOM DAVIS. Thank you. Let me thank this panel very

much. We appreciate your questions. Obviously when we get you

up here we’re going to ask you a lot of things that Members have

questions about. But that’s not new to you.

Mr. HUBBARD. Thank you, Mr. Chairman.

Chairman TOM DAVIS. We appreciate your insights on the bill.

Thank you very much.

We’re going to move to our second panel. We have Dr. Jim

Thompson, of the Federation of State Medical Boards; Dr. Carmen

Catizone, of the National Association of Boards of Pharmacy; Virginia Attorney General Jerry Kilgore; Dr. Rebecca Patchin of the

American Medical Association; and representing the National Community Pharmacists Association, Mr. John Rector.

We may have votes, we’re going to try to get through everybody’s

testimony, we may have votes and have to take a brief recess in

between. I hope everybody’s time can accommodate that. But I will

swear everybody in and we’ll start the testimony and get as far as

we can before we have votes.

Please rise with me and raise your right hands.

[Witnesses sworn.]

Chairman TOM DAVIS. Thank you very much.

Dr. Thompson, we’ll start with you and move straight down.

52

STATEMENTS OF DR. JAMES THOMPSON, M.D., PRESIDENT

AND CHIEF EXECUTIVE OFFICER, FEDERATION OF STATE

MEDICAL BOARDS OF THE UNITED STATES; CARMEN A.

CATIZONE, EXECUTIVE DIRECTOR/SECRETARY, NATIONAL

ASSOCIATION OF BOARDS OF PHARMACY; JERRY W. KILGORE, ATTORNEY GENERAL, COMMONWEALTH OF VIRGINIA;

DR. REBECCA J. PATCHIN, M.D., TRUSTEE, AMERICAN MEDICAL ASSOCIATION; AND JOHN M. RECTOR, SENIOR VICE

PRESIDENT OF GOVERNMENTAL AFFAIRS AND GENERAL

COUNSEL, NATIONAL COMMUNITY PHARMACISTS ASSOCIATION

Dr. THOMPSON. Thank you and good morning to members of the

committee.

I’m Dr. James Thompson, I’m president and CEO of the Federation of State Medical Boards of the United States. The Federation

is a national, non-profit association established in 1912 which

serves as a collective voice for its 70 member State medical licensing and disciplinary boards. The Federation’s primary mission is to

improve the quality, safety and integrity of health care by promoting high standards for physician licensure and practice, as well as

supporting and assisting State medical boards and the protection

of the public.

As I indicated at the hearing this committee held in March 2003,

the Federation has been actively involved as a national leader in

the use of telecommunications and the Internet in the practice of

medicine for a number of years. In 1996, the Federation published

a model act to regulate the practice of medicine across State lines.

In 2000, it published guidelines for Internet prescribing. In 2002,

it published model guidelines for the appropriate use of the Internet in medical practice, one of the first national standards established for Internet medical practice.

Those guidelines which the Federation recommends be adopted

by State medical boards include a key provision, and I’ll quote from

that provision, a documented patient evaluation, including history

and physical evaluation adequate to establish diagnoses and identify underlying conditions and/or contraindications to the treatment

recommended and provided must be obtained prior to providing

treatment, including issuing prescriptions electronically or otherwise.

This has been the key interest of the Federation with respect to

Internet pharmacies. There must be an appropriate relationship

between the patient and the physician before a prescription is written and medication dispensed. In addition to issuing these guidelines, the Federation has aggressively sought to identify Internet

pharmacies that are dispensing drugs on the basis of prescriptions

written by health care providers whose relationship with the patient does not appear to meet minimal standards.

In September 2000, the Federation of State Medical Boards established the national clearinghouse on Internet prescribing to collect and disseminate information on rogue Internet sites offering

prescribing and dispensing services for prescription drugs to consumers. The clearinghouse is uniquely qualified to coordinate information between regulatory and enforcement entities because of its

formal relationship with all the State medical boards in the United

53

States and its territories and its well established lines of communication with State and Federal regulatory agencies, including the

Department of Justice, the Drug Enforcement Agency, the Food

and Drug Administration and the Federal Trade Commission, as

well as the National Association of Boards of Pharmacies, the National Association of Drug Diversion Investigators and the National

Association of Attorneys General, representatives of the pharmaceutical industry and the media.

To date, approximately 12 physicians have been the subject of

disciplinary action actions based on clearinghouse supplied information. The clearinghouse has supplied information for more than

127 cases at the Federal level and more than 200 cases on the

State level. Additionally, information regarding Internet prescribing has been shared with the Medical Counsel of New Zealand and

the Ministry of Health in Germany. The Federation strongly supports State based regulation of the practice of medicine.

With regard to Internet prescribing, however, State medical

boards have the authority to discipline licensed physicians prescribing and dispensing medications inappropriately. Several boards

have already taken action against licensees, adopted rules or policies or introduced legislation to clarify this authority. In addition,

State medical boards are communicating among themselves regarding physicians licensed in more than one State. These cooperative

efforts have been effective in closing several Internet sites and

causing a number of physicians to cease their affiliation with questionable operations.

That said, I also indicated in my testimony last March that there

were at least three issues that needed to be addressed through

Federal legislation in order to protect patients ordering prescriptions over the Internet. I’m very pleased that H.R. 3880, the Internet Pharmacy Consumer Protection Act, addresses each of those

issues.

First, I remarked that patients should know with whom they are

dealing. They should know the name and location of the pharmacy

that is dispensing the drug, and the name of the physician who will

be providing the medical consultation that will be the basis of that

prescription. I noted that almost without exception, a State would

find that such physician had violated practice standards if he or

she wrote a prescription on the basis of an online questionnaire

without having any pre-existing relationship with the patient.

Therefore, disclosure will not only be beneficial to patients but

will allow State medical boards to identify individuals against

whom they can take disciplinary action. H.R. 3880 specifically addresses the issue of disclosure by amending the Food and Drug and

Cosmetic Act with the addition of a new section.

Second, I stated that State attorneys general were not able to enjoin operations of an Internet pharmacy that affects citizens in

their particular States, if that pharmacy is operated out of another

State. Many of our member boards have indicated that they believe

that a number of Internet sites that dispense drugs in an appropriate manner could be shut down if the attorneys general had nationwide injunctive powers as well as the ability to pursue other

civil remedies, including damages, restitution or other compensation across State lines.

54

Third, I noted that while State medical boards have the authority to discipline physicians who are prescribing and dispensing

drugs over the Internet inappropriately and that many boards had

taken such action, State medical boards cannot take action against

operators of Internet sites that dispense drugs. I also remarked

that while State medical boards believe that the law and regulations governing the physicians in their State are clear as to what

constitutes an appropriate physician-patient relationship for purposes of writing a prescription, some courts and prosecutors believed that certain State laws and regulations were ambiguous in

this regard. I noted that because of that ambiguity, prosecutors had

not pursued certain legal actions.

Last, I offered to work with the committee in trying to craft language that would define an appropriate physician-patient relationship for purposes of regulating Internet pharmacies, while preserving the rights and responsibilities of State medical boards. The language in H.R. 3880, adding a new section to the Food, Drug and

Cosmetic Act, strikes a reasonable balance in requiring for the narrow purpose of regulating Internet pharmacies while regulating the

exclusive role of State medical boards and defining that relationship under other circumstances.

In conclusion, H.R. 3880 satisfactorily addresses the issues that

were raised last year by the Federation of State Medical Boards,

and we believe that its enactment into law will provide significant

protection for consumers who use the Internet to obtain pharmaceuticals.

I thank you for the opportunity to testify today, and I’ll be happy

to answer any questions.

[The prepared statement of Dr. Thompson follows:]

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Chairman TOM DAVIS. Thank you very much.

Dr. Catizone.

Mr. CATIZONE. Thank you, Mr. Chairman and good morning committee members. Thank you for the opportunity to be here today.

The National Association of Boards of Pharmacy, which I represent, its members are all the licensing jurisdictions in the United

States, Canada, Australia, New Zealand, and South Africa. The

VIPPS program is an integral component of the services we provide

to the States to help them regulate the Internet and protect the

public health.

Almost 1 year to the day, we appeared before this committee to

report on the activities of the Internet sites offering prescription

drugs for sale. Since that time, much has changed and must has

remained the same. Domestic, legitimate Internet pharmacies continue to provide valuable and innovative services to their patients.

Although not the focus of the proposed legislation, as Chairman

Davis indicated, illegal foreign importation represents a significant

threat to State regulation, and is an issue that should be addressed. Rogue or illegal Internet sites distributing prescription

drugs without a prescription and based in the United States, although a concern, can be identified, and following appropriate due

process, forced to cease operations. The limiting factor for the

States is our resources and nationwide injunctive relief.

The required posting of information by Internet sites outlined by

H.R. 3880 is an important component of identifying and eliminating rogue and illegal sites. However, NABP is concerned that simply mandating the posting without any credible verification of that

information could mislead consumers into believing that illegal or

rogue sites are operating legitimately. The required posting will

also not address foreign sites which pose the biggest problem for

State and Federal regulators.

Some of the examples given today by Mr. Hubbard and others indicate the steps which these rogue or illegal operators will take to

confuse the public and hide information. The simple posting of information without verification does not address this critical issue.

NABP applauds the sponsors of H.R. 3880 for addressing the patient-prescriber relationship and supports the language of the bill.

The proposed revisions, which identify and define a qualifying medical relationship, will close a regulatory loophole exploited by rogue

and illegal Internet sites. Equally as important, the proposed requirement of an in-person medical evaluation will not adversely impact the practices of telemedicine and telepharmacy.

NABP also strongly supports the provisions of H.R. 3880 which

allow States to bring civil action forth to enjoin the practices of illegal Internet sites and obtain nationwide injunctions against their

operations. NABP’s experience indicates that the operators of illegal and rogue sites are extremely knowledgeable about State and

Federal laws and will locate their operations to those States or

areas where their activities are not specifically prohibited, and may

in fact fall within a regulatory grey area. Nationwide injunctive relief will cease these practices and allow States to work together to

close regulatory loopholes and eliminate safe havens within the

United States for illegal and rogue sites.

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NABP and the State Boards of Pharmacy believe that Internet

service providers, advertising services and search engines play a direct role in abetting the activities of illegal and rogue Internet

sites. The inclusion of advertising on their sites from the rogue and

illegal pharmacies misinforms consumers that such sites are legitimate and safe and have been qualified in some way by the ISP, the

search engine or the advertising service. Such activity is a matter

of concern for the States, and at least one State is preparing a formal complaint against such entities for aiding and abetting in a

violation of State and Federal laws.

NABP also requests that the legislation seek to curb the actions

of illegal and rogue sites using credit card companies. NABP has

been informed that information provided to the House Committee

on Energy and Commerce indicates that any purchase made via

Web site using a credit card would allow the credit card company

to locate the merchant bank and other detailed information on the

seller. More importantly, the information presented to the Energy

and Commerce Committee notes that the credit card companies

could quickly terminate relationships with any vendors of such activities that are illegal.

NABP requests that the provisions of H.R. 3880 which hold

harmless interactive computer services or advertising services be

reconsidered, and these entities be required to assume responsibility for their acceptance of funding and services from illegal and

rogue sites which threaten the public health and safety.

Again, we appreciate the opportunity to share our comments

with the committee. We are hopeful that the proposed bill can be

revised to address the concerns of the State boards of pharmacy,

and we’re anxious to work with the sponsors and committee members in achieving this objective of ultimately ensuring that consumers can safely use the Internet to obtain prescription medications.

Thank you.

[The prepared statement of Mr. Catizone follows:]

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Chairman TOM DAVIS. Thank you very much.

General Kilgore, thanks for being with us.

Mr. KILGORE. Good morning. Thank you for inviting me and

thank you for the opportunity to testify today on behalf of attorneys general around the Nation.

In the National Association of Attorneys General, I serve as the

Chair of the Prescription Drug Abuse Task Force. Many of us have

been in Washington this week to discuss important issues facing

our States. The issue of prescription drugs being sold over the

Internet certainly is one of them.

As we all know, the Internet offers tremendous opportunities for

e-commerce, but it’s also a wireless trap for fraud and scams, including the health risks involving the online sales of prescription

drugs. In July of last year, we posted on our office Web site and

issued a media alert warning individuals of the perils of online prescription drugs, including links for information on consumer safety

for online prescription purposes.

Thousands of Virginians rely on prescription drugs for their

health. Seniors and working families struggle to afford prescription

drugs. It is my role as attorney general to ensure that consumers

are protected from online fabricated pharmacies whose main concern is the bottom line, not the health of the purchaser. It is necessary to have the law enforcement tools to shut down those rogue

pharmacies, and that is why I am here today.

Virginia prides itself on being a business friendly State. As Attorneys General, we often look for creative ways for the public and

private sector to work together. There is a legitimate purpose for

online prescription sales, but only when it is narrowly tailored to

provide the convenience and cost effective purchases following an

actual visit with a physician who then prescribes a patient medication that will improve the patient’s health. This legislation targets

those companies who use privacy concerns and convenience at the

expense of the health of the individual.

It is so easy to go to one of these sites and put in information

that doesn’t accurately portray the health condition, such as a

higher weight to allow an individual to purchase diet pills who

really doesn’t need those diet pills. It is also easy for a child to

make up their age to purchase prescription drugs without their

parents knowing. It is so easy to go to one of these sites, get a prescription for a self-prescribed condition, something an individual

may have read off another Internet site. No questionnaire can replace the diagnosis of a physician who knows the patient and understands their health history.

As attorneys general, we have worked together against rogue

pharmacies, but our current enforcement tools are lacking. Right

now, enforcement at the State level is limited to the practice of prescribing and dispensing medication through State laws and licensure agreement. Under this legislation, as attorneys general, we

need the additional enforcement authority to take these individuals

to court to shut down these illegal Internet pharmacies.

It is vital that the Davis-Waxman Internet Pharmacy Consumer

Protection Act be adopted to protect our citizens, because we believe the health care of our citizens is being jeopardized. An individual who is savvy with technology can easily startup one of these

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businesses and make it difficult for law enforcement authorities to

track them down. I want my computer crimes unit to have the authority to go to Federal court and shut down these illegitimate

businesses and get nationwide injunctions if necessary.

We need Congress to give us this authority, so that we can continue to protect the health of our citizens. I urge you to act favorably on this important health protection legislation for the constituents of each member of this committee and indeed, all Americans.

Thank you so much for allowing me to be with you today.

[The prepared statement of Mr. Kilgore follows:]

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Chairman TOM DAVIS. Mr. Kilgore, thank you very much for

being here.

Dr. Patchin.

Dr. PATCHIN. Good morning, Chairman Davis and members of

the committee.

My name is Rebecca Patchin, I’m a physician. I practice in Riverside, CA. I’m an anesthesiologist and I practice full time pain management in an outpatient setting.

In June 2003, I was elected to the AMA Board of Trustees and

we want to thank you for holding the hearing today on this important policy issue. The safety of Internet prescribing and pharmacies.

The AMA appreciates the opportunity to express our views on

Internet pharmacies, and the role of physicians in prescribing and

dispensing of medications through these pharmacies. The Internet

can be a valuable tool as a medical resource, and we support the

use of the Internet as a mechanism to prescribe and dispense medications, as long as appropriate safeguards are in place. These safeguards include ensuring high standards for quality medical care.

I would like to raise three points regarding the regulation of the

Internet as a means of obtaining prescription medications. The first

is the patient-physician relationship, the second is patient safety

regarding the medications they obtain, and the third is the balance

of State, Federal and private regulations. First, the AMA believes

that Internet pharmacy Web sites or physicians that sell or dispense prescription medications without a prescription or without a

valid patient-physician relationship fall well below accepted standards of high quality medical care. They are a threat to the public

health.

Any Internet communications between a patient and their physician should supplement and enhance but not replace the patientphysician relationship. The same must be true for Internet transactions between a physician and the pharmacy on behalf of the patient.

For physicians who prescribe via the Internet, a valid patientphysician relationship requires the following. Performing a physical

examination of the patient, appropriate to the nature and treatment of the problem that is presenting. Taking a complete and reliable medical history and adequate dialog, followup recordkeeping

in order to inform the patients and properly assess the outcome of

the therapeutic intervention.

Exceptions to the criteria that I stated above do exist. Those

would include covering for a partner on a night or weekend for an

existing patient, on call situations and ordering refills for your existing patients. The bottom line is that safeguards must be in place

to make sure that patients receive the appropriate medications

based on their medical history and physical exams.

Next, with respect to the medications obtained through the Internet, patient safety is paramount. Protections need to be in place to

make sure that patients get the medications they need from safe,

reliable and identifiable sources, not from fly by night sites that do

not meet today’s safety standards. The AMA asks that physicians

who practice medicine via the Internet disclose identifying informaVerDate 11-MAY-2000 11:09 Aug 19, 2004 Jkt 000000 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 D:\DOCS\94903.TXT HGOVREF1 PsN: HGOVREF1
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tion on their Web site, including the State or States in which they

are licensed.

This type of disclosure requirement should also apply to the

Internet pharmacies. In addition, patients need a reliable way to

distinguish safe and legitimate sites from fraudulent sites or sites

operating below pharmacy standards. To address this problem, the

AMA will continue to work with organizations such as the National

Association of Boards of Pharmacy to make legitimate sites more

easily identifiable.

In addition, the AMA, in conjunction with the State medical societies, will continue to urge our State medical boards to investigate,

and when appropriate, to take action against physicians who fail

to meet the accepted standards of medical care with regard to

Internet prescribing. We also expect that States will continue to explore various methods of regulating the manner and medium in

which prescription drugs may be prescribed.

Finally, on the Federal level there are currently several bills, including the chairman’s, that address many of the problems we have

cited here today in our written and oral testimony. While the AMA

has not yet taken a position on any particular piece of legislation,

we look forward to working with the Members of Congress to develop appropriate legislative solutions to counter the abusive Internet practices.

Together, we can protect our patients, prevent sub-standard and

illegal Internet prescribing and dispensing of medications, and

mostly, to ensure that the standards for high quality medical care

are fulfilled. Thank you for the opportunity to express our views

before this committee. I would be happy to answer any questions.

[The prepared statement of Dr. Patchin follows:]

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Chairman TOM DAVIS. Thank you, Dr. Patchin.

Mr. Rector.

Mr. RECTOR. Good morning, Mr. Chairman and members of the

committee. I’m particularly pleased to be here to testify on the

Internet Pharmacy Consumer Protection Act, which is directly focused on the domestic marketplace and the Internet traffic in the

United States.

The National Community Pharmacists Association was founded

in 1898. We represent the professional and proprietary interests of

the Nation’s community pharmacists, including the owners of

25,000 pharmacies. We are here to enthusiastically endorse H.R.

3880 and commend the Chair and Ranking Member Waxman for

the work they have done on this measure.

We especially value the disclosure requirements, the disclosure of

the licensure of the pharmacist in the State or States where he or

she is licensed. We further strongly support the focus on a bona

fide relationship with the physician and echo the testimony of several other witnesses this morning in favor of the injunctive relief

for the attorneys general to reach the extra-territorial conduct of

these Internet businesses.

I wanted to make just a few additional comments. Whatever is

done regarding importation, we think you should focus clearly and

in great depth on the domestic marketplace. Basically, Internet is

just another form of mail order pharmacy. Also we’d like to take

a second to put in context our point of view on these issues.

Only one State has enacted a statute requiring the extra-territorial pharmacies to license a pharmacist in their State. Just one

State does that, Arkansas. So it’s important to focus on that. So

disclosure is a step in the direction of informing the consumer so

he or she has the information to know whether or not the pharmacist, if in fact they’re dealing with a pharmacist, is someone licensed in their own State. If they had that information, it might

help them make the appropriate decision, along with the other criteria, as to whether or not they should be doing business with that

particular site.

In our attachment, we highlight a case brought by the U.S. Justice Department versus one of the major domestic mail order companies. We recommend a careful review by the committee members

and staff of the allegations there that have extensive implications

for the subject of this hearing and related issues.

I note that Florida, California, Illinois, Tennessee, Texas, Michigan, Louisiana, Nevada, Virginia, Massachusetts and D.C. are parties to this whistleblower case that the Justice Department has intervened in, which really highlights the weak infrastructure currently in place regulating domestic mail order.

I listened carefully to the comments of the National Association

of Boards of Pharmacy, and we caution the committee not to take

any steps in the bill that is eventually reported that would have

anti-competitive consequences with regards to various private sector initiatives trying to ferret out the rogue pharmacists and their

allies.

And last, we’d like to draw attention also to those that are facilitating these illegal transactions by unlicensed physicians and pharmacies and pharmacists, whether it be the credit card companies

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or those that facilitate the shipment to the ultimate consumer in

these illegal arrangements. We would encourage the various Federal agencies to address these issues, and frankly, we really don’t

think the FDA and HHS have aggressively pursued the enforcement of existing statutes. The Justice Department could take a

close look at the mail order fraud statutes, RICO and others in trying to address the problem that you have so appropriately highlighted.

Thank you.

[The prepared statement of Mr. Rector follows:]

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Chairman TOM DAVIS. Thank you very much.

Dr. Thompson, I understand you need to leave at 12:00?

Dr. THOMPSON. I’ll stay as long as you need me.

Chairman TOM DAVIS. We will not have an intervening vote, so

that’s good. Let’s start the questions, I’ll start with you, Dr.

Thompson. H.R. 3880 gives State attorneys general Federal injunctive relief against online pharmacies that are in violation of the

law. What impact do you think this injunctive relief will have on

shutting down the rogue Internet pharmacy Web sites?

Dr. THOMPSON. The principal problem that we’ve encountered,

quite frankly, is the hesitancy of a number of attorneys general and

the inability of them to go after these rogue sites. That’s only superseded by the fact that it’s very difficult to locate where they are.

Their location and change of location is as simple as changing a

Web page on a daily basis.

But it would significantly increase an attorney general’s ability

to close down pharmacies that are operating in not only other

States, but multiple States, and be able to go after those rogue

sites as well as allowing us to go after the physicians that are involved in this practice.

Chairman TOM DAVIS. Mr. Kilgore, do you agree with that?

Mr. KILGORE. I do, Mr. Chairman. It’s important that State attorneys general have this ability. How I envision it would work is

that we would join together with other attorneys general around

the Nation when we identify one of these sites to go in and shut

it down.

Chairman TOM DAVIS. You still have a problem identifying it,

but at least now you would have a legal recourse, which you really

don’t now.

Mr. KILGORE. That’s right. It’s much the way we have to do, Mr.

Chairman, with spammers under Virginia’s anti-spam law, under

the new one passed by Congress. It’s difficult to identify these individuals because criminals find new ways every day to go out and

make money. But we can do it just, the authority, the injunctive

authority gives us greater abilities to go into Federal courts and

shut them down.

Chairman TOM DAVIS. What we continue to see is consumers

going to these Web sites, though. What’s troubling is that consumers are going to the Web sites because they think they’re getting

cheaper drugs or whatever. And we today have heard a lot of testimony on how bogus a lot of these drugs are. Aside from the fact

that even if they were correct, they may or may not work and do

what they were prescribed to do, because you don’t have the physician-patient relationship, many of these drugs are actually bogus.

We passed some around up here that are routinely delivered over

the Internet.

What do we do to better inform consumers of the problems in

this?

Mr. CATIZONE. Mr. Chairman, I think that’s a major dilemma,

because we’re sending mixed messages to consumers. On one hand

we’re telling them it’s OK to import medications from Canada, and

we don’t know if those sources are truly Canada, and on the other

hand, we’re saying they’re very dangerous, and we have examples

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sumer complaints about medications ordered over the Internet, at

least $20,000 worth of consumer fraud where they ordered medications and didn’t receive those medications, and a number of complaints that the products were counterfeit or didn’t have any active

ingredient whatsoever.

So that’s a significant challenge for us, sending one message to

the consumer about using the distribution system that’s approved

and safeguarded by the FDA and State agencies.

Chairman TOM DAVIS. I guess if anybody, if they would counterfeit a prescription, with a physician writing a prescription, without

it, they’d certainly counterfeit the drug, I don’t know why there

would be any difference on that. Does anybody else have any observations on that?

Mr. KILGORE. Mr. Chairman, I would say that traveling around

Virginia and speaking with senior organizations, I’ve picked up on

the mixed messages that they are getting as well. That’s why we

felt it was important to weave into every presentation to senior organizations around Virginia the fact that you must be sure who

you are dealing with when you are ordering prescriptions online or,

and reminding our seniors that Virginia law does not allow the importation, and further making it clear that you need to retain that

doctor-patient relationship, so that they know exactly how each

drug interacts with other drugs.

Chairman TOM DAVIS. Dr. Patchin, let me ask you, you didn’t

specifically endorse any piece of legislation. I know your organization is careful not to do that. But do you think the provisions that

we have in this legislation that Mr. Waxman and I have drafted,

defining an appropriate medical relationship is consistent with

AMA guidelines regarding prescribing medications?

Dr. PATCHIN. Yes, they appear consistent. And on your last question, I might add, I practice in a border State, and a State where

the importation is not Canada, and where many of our imported

medications come in. I view it as patient education, something that

I work with one on one with my patients about the safety of the

medications that they may get from other areas by driving a few

hundred miles. Again, they need to look at safety and whether the

medication is really what they’re getting.

Chairman TOM DAVIS. My time is up, but real quick, does the

AMA think it’s important for Internet pharmacy sites to disclose

physician identifying information, like their licensure information

on their Web sites?

Dr. PATCHIN. Yes. In my testimony, I stated that the physician

and the pharmacy should have identifying information, so that the

patient could contact the pharmacy as well as the physician.

Chairman TOM DAVIS. Thank you very much. Mr. Waxman.

Mr. WAXMAN. Thank you very much, Mr. Chairman.

Mr. Kilgore, you testified about the importance of the provision

in this bill that would give State attorneys general the ability to

shut down illegitimate Internet pharmacies nationwide. Would

having the power to obtain nationwide injunctions encourage more

enforcement by State attorneys general against these Web sites,

and would this power be consistent with traditional State authority

over the practice of medicine and pharmacy?

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Mr. KILGORE. It absolutely would encourage us to take action.

The reluctance at this point, we can take action under State laws

sometimes, but we cannot find these individuals. We need this ability so that we can join with other attorneys general and shut these

down.

Mr. WAXMAN. So what we do is provide a nationwide opportunity

to deal with this problem but not take away the prerogative of the

States as they’ve traditionally dealt with some of these issues?

Mr. KILGORE. That’s correct. We appreciate that.

Mr. WAXMAN. Thank you. Mr. Catizone, you testified in strong

support of the two key provisions of the bill. You endorsed the establishment of Federal standards for what is a valid prescription

related to Internet prescribing. You also supported giving State attorneys general the authority to shut down these sites nationwide.

I’d like to ask you about two areas where you’ve made some suggestions for improvement in the legislation. First, you’ve expressed

concern about how the legislation deals with Internet service providers and search engines that might sell advertisements to illegitimate pharmacies. Are you aware of efforts by Yahoo, Google and

other Internet companies to refuse to sell advertisements by some

of these Internet pharmacies?

Mr. CATIZONE. Yes, I am, sir. We spoke to those search engines

and they’ve indicated they are interested in doing so. We’re not

convinced that their efforts go far enough. They seem to be accepting accreditation or approval processes that don’t involve a very serious inspection of those sites or very serious review of what they’re

doing. In fact, they probably will be accepting advertisements from

Canadian pharmacies which are operating illegally.

Mr. WAXMAN. What makes this a difficult issue is that the intent

of the legislation is to focus on those responsible for the illegitimate

Web sites, not those who make the sites available to the public. I

want to look over your suggestion, I think it’s one we need to carefully consider, and I appreciate that thought behind it.

You’ve also made the suggestion that Internet pharmacies should

participate in a formal disclosure and verification program such as

the VIPPS program, which is run by the National Association of

Boards of Pharmacy. You suggested that one benefit of such an approach might be better enforcement.

Are you suggesting that participating in VIPPS or in an equivalent program be required of all Internet pharmacies?

Mr. CATIZONE. Mr. Waxman, we’ve talked about this issue with

a variety of groups and yes, we’re recommending some mandatory

program. The voluntary program isn’t going far enough, and those

sites will do anything they can to confuse consumers and to hide

information. So simply requiring the posting of information that

will probably be fraudulent in many cases won’t help the consumers.

Mr. WAXMAN. How many participating Internet pharmacies does

VIPPS certify now?

Mr. CATIZONE. We currently have 13 sites representing 8,000 to

10,000 pharmacies in the United States.

Mr. WAXMAN. And if all the Internet pharmacies were required

to participate in VIPPS, how many do you think might apply?

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Mr. CATIZONE. They estimate that the Internet pharmacy market

is anywhere between 8 percent and 22 percent of existing pharmacies. There are probably right now 75,000 pharmacies licensed

in the United States. So that number would be 8 percent to 10 percent of that, upward to 7,500 pharmacies.

Mr. WAXMAN. I appreciate the advantages of the VIPPS program.

It’s a model we believe the Secretary should look at when considering how to implement this bill. However, regulating a few large

Internet pharmacies is not the same as monitoring what could be

hundreds of thousands of Internet pharmacies. This is an enforcement challenge for anyone, whether VIPPS or FDA or the State attorneys general. We’ll review this situation carefully. I think it’s

one that I’m pleased you brought to our attention.

Dr. Patchin, your testimony covered a wide variety of topics, but

I want to ask you about a couple of specifics. You testified that current AMA policy requires physicians to prescribe via the Internet

to clearly disclose physician identifying information on the Web

site. Are you aware that H.R. 3880 includes this requirement as

well as the requirement that pharmacies also be identified, and

would you agree that the disclosure provisions in this bill are consistent with AMA policy?

Dr. PATCHIN. At this time, yes.

Mr. WAXMAN. OK, good. And you testified that AMA policy prohibits prescribing medications without a valid doctor-patient relationship. This includes performing a physical examination adequate

to establish the diagnosis, having sufficient dialog with the patient

regarding risks and maintaining a medial record that’s readily

available to the patient.

In your judgment, is a doctor who churns out prescription after

prescription on the basis of little or no information through an arrangement with an Internet pharmacy in compliance with AMA

policy? And are you aware that this bill prohibits Internet pharmacies from arranging for doctors to write prescriptions to consumers without ever seeing them?

Dr. PATCHIN. The physician who writes a prescription without

the patient-physician relationship as we described would be in violation of AMA policy, correct.

Mr. WAXMAN. Do you think this is a good provision for accomplishing that goal?

Dr. PATCHIN. Yes.

Mr. WAXMAN. Thank you very much.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much. Mr. Carter, any

questions?

Mr. CARTER. Thank you, Mr. Chairman.

When we’re dealing with lawsuits in the United States, the

plaintiff’s bar will argue that a lot of what they do as taking actions in the plaintiff’s bar is policing up organizations that don’t police themselves and targeted, as AMA. But the doctors don’t police

up their malpractice.

Now, what I’ve heard testimony here today is that you would

sanction, I would like to know exactly, if you were to identify a doctor who is operating this illegal procedure, what sanction would

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you take with that doctor? Would you punch his ticket and stop

him from practicing medicine?

Dr. THOMPSON. Yes, sir. The Federation of State medical boards

is the membership association of the Nation’s 70 licensing and territorial regulatory authorities. A number of licenses have been revoked and there have been disciplinary actions taken against a

number of physicians that have been involved in this kind of activity. It can be anything from a slap on the hand to a license revocation. But the kind of activity that we’ve seen more often than not

leads to revocation of a license.

Difficult, however to track these physicians down and very difficult to work across State lines in this kind of activity.

Mr. CARTER. I understand that we’re giving tools to the attorneys

general across the States to try to help do this. But part of the ultimate solution has to be, those people who are violating standards,

violating laws and threatening lives have to be taken out of the

system. If they’re not taken out of the system, they’re going to figure out another crooked way to do this thing.

Dr. THOMPSON. The most notorious of the individuals who deals

with Internet prescriptions had a license in 26 different States, and

to date has had 14 of those removed and by reciprocal action

through the information services that we provide through the Federation is soon on his way to having all of his licenses revoked.

Mr. CARTER. And the same question I would direct to the people

involved in pharmacy. Would the pharmacies also punch the ticket

on people who are doing this what I consider illegal operation?

Dr. THOMPSON. Yes, sir.

Mr. CARTER. That’s all the questions I have, Mr. Chairman.

Thank you.

Chairman TOM DAVIS. Thank you very much. Mr. Towns.

Mr. TOWNS. Thank you very much, Mr. Chairman.

Let me begin with you, Dr. Patchin. You used the term ‘‘safeguards must be in place’’ on two occasions. What do you mean by

safeguards must be in place?

Dr. PATCHIN. Safeguards regarding the Internet prescribing

would be to those that ensure that there is an approved supply of

drugs that are the right dose, the right drug for the right patient,

with the right, appropriate dosing interval and the right time. The

safeguards for prescribing would also include State laws that govern the practice of medicine as well as the prescribing in the community standard.

Mr. TOWNS. Thank you. My concern, and I guess this is to the

Attorney General, this legislation is dealing with domestic Web

sites, it doesn’t do anything with international Web sites. And I’m

sort of concerned about the fact that once the noose is tightened

that we might have a problem in terms of people going out of the

country and doing almost the same thing. So what do we do here?

I’m concerned, I’m in favor of shutting down all Internet pharmacy sites. However, it appears that better oversight and controls

are needed, but purchasing drugs through the Internet can offer incredible, no question about it, benefits for homebound patients.

And of course, patients that might have a disease of some sort that

might not want the world to know, there’s benefits there as well.

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But I am concerned, so I’d like to hear your comments about,

once we tighten the noose, what we might run into.

Mr. KILGORE. That very well could happen. This is a great first

step to control the domestic Internet companies. It’s a great first

step to give State attorneys general the ability to enforce the act.

We recognize that as we go about enforcing the act that, as we shut

down Internet pharmacies that we could see the effect you are talking about, i.e., the move overseas, they go international, then we

will have to address that through our relationship with the FDA

and work with the FDA and DEA on those important issues.

Mr. TOWNS. Thank you. I guess this is for the doctors on the

panel. In your experience, do health care professionals typically inquire about where a patient obtains his or her prescription drug before making changes or switching to an alternative product? Is that

question generally asked, where you get your medication from?

Dr. PATCHIN. Yes. Part of the assessment in obtaining the history

and physical would be questions to find out what medications they

are taking and who is prescribing them. You will find out where

they’re filling them. Many times I find out even the name of the

pharmacy or the provider that they’re getting their medications

dispensed from.

Dr. THOMPSON. Dr. Patchin is an anesthesiologist who deals in

pain management, so she’s more likely dealing with the type of

drugs that we’re talking about. I’m an ear, nose and throat doctor,

and I infrequently deal with heavy narcotics and so in my practice,

I would not necessarily have known where someone filled their prescription. I would, however, know what drugs they have been taking and for what reason they have been taking them.

Mr. TOWNS. Mr. Catizone, I want to hear from you on this.

Mr. CATIZONE. That’s a very critical question. We’re trying to

work with the physician groups to ask patients that question. Because if their blood pressure is uncontrollable or their diabetes

worsens, the assumption made is that the medication is not working, so they increase the dose or change the medication, when it

could be a counterfeit product or a product that has no active ingredients.

So we would also ask that be a consideration of any of these discussions. We’re going to ask the FDA to change their Med Watch

form to allow for that information to be asked, so they can identify

whether it came from outside the U.S. distribution system.

Mr. TOWNS. Let me say, Mr. Chairman, I think this legislation

is good. But the question in my mind is, does it go far enough. I

would like to have an extra second or two just to run down the line

and ask each member in terms of what they might want to add to

make it better.

Chairman TOM DAVIS. Sure.

Dr. THOMPSON. First of all, let me say that for the purposes of

addressing the problem that this committee has been confronted

with, this legislation is excellent. I would applaud the Chair and

the other leaders of this committee for I think superb legislation

that will deal with the issue.

Chairman TOM DAVIS. Take as much time as you need. [Laughter.]

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Dr. THOMPSON. There are a number of other issues, however,

that relate to the technology, and we in this Nation have seen a

situation in which the technology has far superseded our ability to

deal with the ethics or the regulation of that technology. And quite

frankly, we’re playing catchup. This is a giant leap forward, I believe, for the citizens in this country. There remains much work to

be done, however.

Mr. CATIZONE. I would echo Dr. Thompson’s compliments on the

bill. Absent the fact that we believe the disclosure should be mandatory, should be verified, in regard to the patient and the question

of where the medication should be obtained from, that may not be

a matter for legislation. That’s a matter for the Federation and the

American Medical Association to work together and increase that

as a standard of care for patients as part of the diagnosis differential.

Mr. KILGORE. I totally support this legislation. It’s a great move

forward, and a great move to protect patients’ rights in the future,

and it gives certainly attorneys general around the Nation the ability to protect our consumers. The one issue I think we must deal

with in the future is the important issues, so that we avoid sending

mixed messages to our seniors and others in our State about

whether they should be able to import drugs from foreign countries. We need to, if we allow that we need to make sure those

drugs are safe, those drugs are accurate, and we continue to require a physician-patient relationship.

Dr. PATCHIN. I would like to make a plea for the patient’s safety.

The patient’s safety is ensuring that they’re getting the right drug,

in the right concentration, in the right vehicle and the right timing

as part of the patient-physician relationship in that prescribing.

Mr. RECTOR. We strongly endorse the legislation in each of its

key provisions. We think it’s carefully drawn to avoid any anti-competitive consequences by endorsing one private sector certification

program over another. But a related subject, not necessarily for

this committee, but perhaps, would be to carefully review the statutes that are available to prosecute those entities that are facilitating the illegal commerce, both foreign and domestic. That means

the shippers and the credit card companies and others. If the subject was stolen property, there would be no question. This is a lot

more serious, typically, than stolen property.

Mr. TOWNS. Thank you very much. Mr. Chairman, I don’t have

anything to yield back, so I’ll just stop. [Laughter.]

Chairman TOM DAVIS. Thank you very much, Mr. Towns. I just

want to ask a couple of followup questions.

Mr. Rector, you stated in your testimony that the regulation of

the practice of pharmacy by pharmacists rests exclusively with the

respective States. I just want you to reiterate again for the record

the need for H.R. 3880 as a Federal law when you already have

the State regulation from your perspective as a pharmacist.

Mr. RECTOR. We think that H.R. 3880 ideally complements the

jurisdiction that the States enjoy, both over the practice of medicine and the practice of pharmacy.

Chairman TOM DAVIS. And the world has basically changed with

the Internet, isn’t that what’s happened here, and everybody

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agrees, that the old rules don’t apply when you have such a ubiquitous communications device as the Internet?

Mr. RECTOR. Absolutely.

Chairman TOM DAVIS. And certainly, Mr. Kilgore, from an enforcement point of view it changes everything. You noted it’s hard

to find these people, and in many cases, you really want to join

with other attorneys general to shut them down, because you’re

chasing them all over the globe?

Mr. KILGORE. That’s true. The Internet has become the wild

west, if you will, and we need this added ability in our enforcement

tools to go after these rogue pharmacies.

Chairman TOM DAVIS. Let me ask you, with your experience on

spammers, I know you brought one of the first cases in the country

prosecuting spamming and so on, how is that going? You used one

of your strongest State laws, I know, which you and Senator Stiley

and Senator Devolites helped write. How has that helped and what

does your experience on that tell you about this?

Mr. KILGORE. Again, it confirms our fear in the State that these

cases take a lot of time, a lot of energy in our office to investigate

and track down these individuals that are committing crimes. We

have charts and charts that fill up a room where we’ve traced the

ISPs from, gone to the ISP to get their address only to find out

they’re operating in many different domains. It just takes a lot of

time and computer crunching. But we continue to investigate, just

like we will once we are given this authority under this legislation

to investigate and shut down these pharmacies.

Chairman TOM DAVIS. As I understand it, today, if someone is

selling Lipitor and it’s not Lipitor, or they’re selling Viagra and it’s

not Viagra, you can prosecute them for that if you can run them

down, is that right?

Mr. KILGORE. That is correct.

Chairman TOM DAVIS. But this gives you the additional tool, because they’re doing it without a prescription, and that’s probably

even easier to prove, is that probably——

Mr. KILGORE. Much easier.

Chairman TOM DAVIS. Everybody understands this is just an additional tool to try and get some of these folks. In addition to that,

without the appropriate medical authorization, people are at risk.

The new disclosure standards ought to help identify the offending

Web site, shouldn’t it? We talked about pharmacies and doctors,

talked about where you get it, wouldn’t that help disclose the offending Web sites as well?

Mr. KILGORE. I would think it would.

Mr. CATIZONE. We think it’s a first step. We think it’s not going

to address the issue entirely, though.

Chairman TOM DAVIS. OK. Well, thank you very much. This has

been very helpful to us. We’d like to do something about that, and

having the support and the testimony from your organizations is

very critical in this. Again, I want to thank all the witnesses for

taking their time to testify today. And the hearing is closed.

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Thank you.

[Whereupon, at 12:01 p.m., the committee was adjourned, to reconvene at the call of the Chair.]

[The prepared statement of Hon. Carolyn B. Maloney and additional information submitted for the hearing record follow:]

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