[Congressional Record Volume 150, Number 72 (Thursday, May 20, 2004)]
[Senate]
[Pages S5983-S5985]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. COLEMAN:
  S. 2465. A bill to amend the Controlled Substances Act with respect 
to the seizure of shipments of controlled substances, and for other 
purposes; to the Committee on the Judiciary.
  Mr. COLEMAN. Mr. President, I rise to introduce two bills that expand 
Federal authority to prevent controlled substances from flooding into 
the U.S., authorizing states to shut down illegitimate virtual 
pharmacies, and bar Internet drug stores from dispensing drugs to 
customers referred to on-line doctors for a prescription.
  Americans are increasingly turning to the Internet for access to 
affordable drugs. In 2003, consumer spending on drugs procured over the 
Internet exceeded $3.2 billion. Unfortunately, rogue Internet sites 
have proliferated and rake in millions of dollars by selling unproven, 
counterfeit, defective or otherwise inappropriate medications to 
unsuspecting consumers. Even more dangerously, these sites are 
profiting by selling addictive and potentially deadly controlled 
substances to consumers without a prescription or any physician 
oversight. This must stop before more individuals die or become 
addicted to easily obtainable narcotic drugs.
  The first bill I am introducing was developed in close consultation 
with Senator Feinstein, who is an original cosponsor. In appreciation 
for her role in helping write this legislation it is named after a 
young man from her state who died from an overdose of drugs purchased 
over the Internet.
  17-year old Ryan Haight of La Mesa, CA was an honor roll student, and 
avid baseball card collector about to enter college. As his mom says, 
``he was a good kid.'' But in May of 2000 Ryan started hanging out with 
a different crowd of friends. He joined an online chat forum, which 
advocates the safe use of drugs, and he began buying prescription drugs 
from the Internet.
  He used the family computer late at night and a debit card his 
parents gave him to buy baseball cards on Ebay. You might ask, how did 
a healthy 17-year old obtain prescriptions for painkillers without a 
medical exam. He got them from Dr. Robert Ogle an ``online'' physician 
based out of Texas. With the prescriptions from Dr. Ogle, Ryan was able 
to order hydrocodone, morphine, Valium and Oxazepam and have them 
shipped via US mail right to his front door.
  In February 2001, Ryan overdosed on a combination of these 
prescription drugs. His mother found him dead on his bedroom floor.
  The Ryan Haight Internet Pharmacy Consumer Protection Act counters 
the growing sale of prescription drugs over the Internet without a 
valid prescription by 1. providing new disclosure standards for 
Internet pharmacies; 2. barring Internet sites from selling or 
dispensing prescription drugs to consumers who are provided a 
prescription solely on the basis of an online questionnaire; and 3. 
allowing State Attorneys General to go to Federal court to shut down 
rogue sites.
  The bill is geared to counter domestic Internet pharmacies that sell 
drugs without a valid prescription, not international pharmacies that 
sell drugs at a low cost to individuals who have a valid prescription 
from their U.S. doctors.
  Under current law, purchasing drugs online without a valid 
prescription can be simple: a consumer just types the name of the drug 
into a search engine, quickly identifies a site selling the medication, 
fills in a brief questionnaire, and then clicks to purchase. The risks 
of self-medicating, however, can include potential adverse reactions 
from inappropriately prescribed medications, dangerous drug 
interactions, use of counterfeit or tainted products, and addiction to 
habit-forming substances. Several of these illegitimate sites fail to 
provide information about contraindications, potential adverse effects, 
and efficacy.
  Regulating these Internet pharmacies is difficult for Federal and 
State authorities. State medical and pharmacy boards have expressed the 
concern that they do not have adequate enforcement tools to regulate 
practice over the Internet. It can be virtually impossible for States 
to identify, investigate, and prosecute these illegal pharmacies 
because the consumer, prescriber, and seller of a drug may be located 
in different States.
  The Internet Pharmacy Consumer Protection Act amends the Federal 
Food, Drug, and Cosmetic Act to address this problem in three steps. 
First, it requires Internet pharmacy websites to display information 
identifying the business, pharmacist, and physician associated with the 
website.
  Second, the bill bars the selling or dispensing of a prescription 
drug via the Internet when the website has referred the customer to a 
doctor who then writes a prescription without ever seeing the patient.

[[Page S5984]]

  Third, the bill provides States with new enforcement authority 
modeled on the Federal Telemarketing Sales Act that will allow a state 
attorney general to shut down a rogue site across the country, rather 
than only bar sales to consumers of his or her state.
  I am proud to say that the Ryan Haight Internet Pharmacy Consumer 
Protection Act is supported by the Federation of State Medical Boards, 
the National Community Pharmacists Association, and the American 
Pharmacists Association.
  The second bill I am introducing enables Customs and Border 
Protection to immediately seize and destroy any package containing a 
controlled substance that is illegally imported into the U.S. without 
having to fill out duplicative forms and other unnecessary 
administrative paperwork. The Act will allow Customs to focus on 
interdicting and destroying potentially addictive and deadly controlled 
substances. The Act is dedicated to Todd Rode, a young man who died 
after overdosing on imported drugs.
  Todd Rode had the heart and soul of a musician. He graduated from 
college magna cum laude with a major in psychology and a minor in 
music. The faculty named him the outstanding senior in the Psychology 
Department. He worked in this field for a number of years, but he 
constantly fought bouts of depression and anxiety.
  Unfortunately Todd ordered controlled drugs from a pharmacy and 
doctor in another country. These drugs included Venlafaxine, 
Propoxyphene, and Codeine. All were controlled substances and all were 
obtained from overseas pharmacies without any safeguards. To obtain 
these controlled substances all Todd had to do was to fill out an 
online questionnaire and with the click of a mouse they were shipped 
directly to his front door.
  In October of 1999, Todd's family found him dead in his apartment.
  A six-month investigation by the Permanent Subcommittee on 
Investigations has revealed that tens of thousands of dangerous and 
addictive controlled substances are streaming into the U.S. on a daily 
basis from overseas Internet pharmacies. For example, on March 15 and 
17, 2004, at JFK airport, home to the largest International Mail Branch 
in the U.S., at least 3,000 boxes from a single vendor in 
the Netherlands containing hydrocodone and Diazepam (Valium) were 
seized by Customs and Border Protection (Customs).

  In fact, senior Customs inspectors at JFK estimate that 40,000 
parcels containing drugs are imported on a daily basis. During last 
summer's FDA/Customs blitz, 28 percent of the drugs tested were 
controlled substances. Extrapolating these figures, 11,200 drug parcels 
containing controlled substances are imported through JFK daily, 78,400 
weekly, 313,600 monthly and 3,763,200 annually. top countries of origin 
include Brazil, India, Pakistan, Netherlands, Spain, Portugal, Canada, 
Mexico, and Romania.
  Likewise, as of March 2003, senior Customs officials at the Miami 
International Airport indicated that as much as 30,000 packages 
containing drugs were being imported on a daily basis. A large 
percentage of these are controlled substances as well. Customs is 
simply overwhelmed. At Mail facilities across the U.S., Customs 
regularly seizes shipments of oxycodone, hydroquinone, tranquilizers, 
steroids, codeine laced products, GHB, date rape drug, and morphine.
  In order to comply with paperwork requirements, Customs is forced to 
devote investigators solely to opening, counting, and analyzing drug 
packages, filling out duplicative forms, and logging into a computer 
all of the seized controlled substances. It takes Customs at least one 
hour to process a single shipment of a controlled substance. This 
minimizes the availability of inspectors to screen incoming drug 
packages. In fact, currently at JFK, there are 20,000 packages of 
seized controlled substances waiting processing. Customs acknowledges 
that, because of the sheer volume of product, bureaucratic regulations, 
and lack of manpower, the vast majority of controlled substances that 
are illegally imported are simply missed and allowed into the U.S. 
stream of commerce.
  The Act to Prevent the Illegal Importation of Controlled Substances 
is a simple bill to address this burgeoning and potentially lethal 
problem.
  I am confident that, if enacted as stand-alone measures, each of 
these bills will make on-line drug purchasing safer. However, I am 
working with Senator Gregg to ensure these safety features are included 
in his comprehensive reimportation bill and urge my colleagues to help 
make sure that this important piece of legislation becomes law this 
year.
  Mrs. FEINSTEIN. Mr. President, I rise today along with my colleague 
Senator Coleman to introduce the Internet Pharmacy Consumer Protection 
Act also called the ``Ryan Haight Act'', a bill which is vital to 
protect the safety of Americans who choose to purchase their 
prescription drugs legally over the Internet.
  This legislation is necessary because of a growing problem of illegal 
prescription drug diversion and abuse of prescription drugs. Coupled 
with the ease of access to the Internet, it has led to an environment 
where illegitimate pharmacy websites can bypass traditional regulations 
and established safeguards for the sale of prescription drugs. Internet 
websites that allow consumers to obtain prescription drugs without the 
existence of a bona fide physician-patient relationship pose an 
immediate threat to public health and safety.
  To address this problem, the Internet Pharmacy Consumer Protection 
Act makes several critical steps to ensure safety and to assist 
regulatory authorities in shutting down ``rogue'' Internet pharmacies.
  First, this bill establishes disclosure standards for Internet 
pharmacies.
  Second, this bill prohibits the dispensing or sale of a prescription 
drug based solely on communications via the Internet such as the 
completion of an online medical questionnaire.
  Third, it allows a State Attorney General to bring a civil action in 
a federal district court to enjoin a pharmacy operation and to enforce 
compliance with the provisions of this law.
  Under this bill, for a domestic website to sell prescription drugs 
legally, the website would have to display identifying information such 
as the names, addresses, and medical licensing information for 
pharmacists and physicians associated with the website.
  In addition, if a person wants to use the Internet to purchase their 
prescription drugs he or she will not be prohibited from doing so under 
this bill but, in order to do so, must already have a prescription for 
the drug that is valid in the United States prior to making the 
Internet purchase.
  Reliance on the Internet for public health purposes and the expansion 
of telemedicine, particularly in rural areas, make it essential that 
there be at the very least a minimum standard for what qualifies as an 
acceptable medical relationship between patients and their physicians.
  According to the American Medical Association, a health care 
practitioner who offers a prescription for a patient he or she has 
never seen before, based solely on an online questionnaire, generally 
does not meet the appropriate medical standard of care.
  Let me illustrate the situation facing our country today. If a 
physician's office prescribed and dispensed prescription drugs the same 
way Internet pharmacies currently can and do, it would look something 
like this: A physician opens a physical office, asks a patient to fill 
out a medical history questionnaire in the lobby and give his or her 
credit card information to the office manager. There is no nurse, and 
therefore no one to take the patients' height, weight, blood pressure, 
verify his or her medical history, and so forth and no one to answer 
the patient's questions regarding their health.
  The questionnaire is then slipped through a hole in the window; the 
office manager takes it to the physician, or person acting as the 
physician, who then writes the prescription and hands it to the 
pharmacist, or person acting as the pharmacist, in the next room. Once 
the patient signs his credit card, he is on his way out the door, drugs 
in hand.
  No examination is performed, no questions asked, and no verification 
or clarification of the answers provided on the medical history 
questionnaire.
  This illustration is not an exaggeration. It occurs every day all 
across the United States. The National Association of Boards of 
Pharmacy estimates

[[Page S5985]]

that there are around 500 identifiable rogue pharmacy websites 
operating on the Internet.
  According to the Federation of State Medical Boards, approximately 29 
states and the District of Columbia either have laws or medical board 
initiatives addressing Internet medical practice. Of the other 21 
States, 13 have medical or osteopathic medical boards that have taken 
disciplinary action against a physician for prescribing medication 
online.

  Many States have already enacted laws defining acceptable practices 
for qualifying medical relationships between doctors and patients and 
this bill would not affect any existing State laws.
  For example, California law was changed in 2000 to say:

       No person or entity may prescribe, dispense, or furnish, or 
     cause to be prescribed, dispensed, or furnished dangerous 
     drugs or dangerous devices [defined as any drug or device 
     unsafe for self-use] on the Internet for delivery to any 
     person in this state, without a good faith prior examination 
     and medical indication . . .

  I believe California's law is a perfect example of why this 
legislation is needed. The law only applies to persons living in 
California. As we all know, however, the Internet is not bound by State 
or even country borders.
  This legislation makes a critical step forward by providing 
additional authority for State Attorneys General to file an injunction 
in Federal court to shut down an Internet site operating in another 
State that violates the provisions in the bill.
  Under current law, in order to close down an Internet website selling 
prescription drugs prosecutors must take enforcement actions in every 
State where the Internet pharmacy operates, requiring a tremendous 
amount of resources in an environment where the location of the website 
is difficult, if not impossible, to determine or keep track of.
  This bill will allow a State Attorney General to bring a civil action 
in a Federal district court to enjoin a pharmacy operation and to 
enforce compliance with the provisions of the law in every jurisdiction 
where the pharmacy is operating.
  While this legislation pertains to domestic Internet pharmacies, the 
practice of international pharmacies selling low-cost drugs to U.S. 
consumers who have valid prescriptions from their doctors deserves to 
be discussed and debated on the Senate floor. It is my hope that the 
Senate will act this year on prescription drug importation legislation.
  In closing, I want to share with you the story of Ryan T. Haight of 
La Mesa, CA in whose memory this bill is named.
  Ryan was an 18-year old honor student from La Mesa, CA, when he died 
in his home on February 12, 2001. His parents found a bottle of Vicodin 
in his room with a label from an out-of-state pharmacy.
  It turns out that Ryan had been ordering addictive drugs online and 
paying with a debit card his parents gave him to buy baseball cards on 
eBay.
  Without a physical exam or his parents' consent, Ryan had been 
obtaining controlled substances, some from an Internet site in 
Oklahoma. It only took a few months before Ryan's life was ended by an 
overdose on a cocktail of painkillers.
  Ryan's story and others like it force us to ask why anyone in the 
U.S. would be able to access such highly addictive and dangerous drugs 
over the Internet with such ease?
  Why was there no physician or pharmacist on the other end of this 
teenager's computer verifying his age, his medical history and that 
there was a valid prescription?
  That is why I support this legislation. It makes sensible 
requirements of Internet pharmacy websites that will not impact access 
to convenient, oftentimes cost-saving drugs.
   With simple disclosure requirements for Internet sites such as 
names, addresses and medical or pharmacy licensing information, 
patients will be better off and state medical and pharmacy boards can 
ensure that pharmacists and doctors are properly licensed.
  Lastly, this bill will give State Attorneys General the authority 
they need to shut down rogue Internet pharmacies operating in other 
States. I urge my colleagues to support this bill.
                                 ______