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DRUGS |
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Testimony before the U.S. House of Representatives
Statement
of Joe Rannazzisi Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration
Committee on House Government Reform Subcommittee on Criminal Justice,
Drug Policy, and Human Resources
July 26, 2006
Chairman Souder, Ranking Member Cummings, and distinguished members
of Subcommittee, on behalf of Administrator Tandy and the Drug Enforcement
Administration (DEA), I appreciate your invitation to testify today
regarding DEA's efforts to address the issue of prescription drug
abuse.
Overview
Addressing the growing problem of the diversion and abuse of controlled
pharmaceuticals continues to be one of the top priorities of the Drug
Enforcement Administration. DEA has made great strides in dealing
with this ever-changing, global drug issue. We continue to concentrate
on identifying, targeting, and dismantling largescale organizations
that seek to divert and distribute controlled pharmaceuticals in violation
of the Controlled Substances Act (CSA). An illustration of the Administration's
focus on this problem occurred on June 1, 2006, when the Department
of Justice, along with the DEA, the Office of National Drug Control
Policy, the Department of Homeland Security, the Department of Health
and Human Services, and other agencies announced a comprehensive Synthetic
Drug Control Strategy, which among other significant drug threats,
specifically targets prescription drug abuse. The DEA is keenly aware
of this problem.
An examination of youth drug abuse data reveals that the percentage
of young Americans abusing prescription drugs is second only to marijuana
and ahead of cocaine, heroin, methamphetamine, and other drugs. DEA,
as the nation's primary law enforcement agency dedicated to enforcing
the Controlled Substances Act, plays an integral role in achieving
the goals of the Administration's Synthetic Drug Control Strategy.
As outlined in that Strategy, we have committed to an ambitious goal
of reducing the abuse of controlled pharmaceuticals by 15 percent
over the next three years.
DEA's obligation under the law and to the public is to ensure that
pharmaceutical controlled substances are prescribed and dispensed
only for legitimate medical purposes in accordance with the Controlled
Substances Act. By carrying out this obligation, DEA strives to minimize
the diversion of pharmaceutical controlled substances for abuse while
ensuring that such medications are fully available to patients in
accordance with the sound medical judgments of their physicians. In
this manner, DEA is committed to balancing the need for prevention,
education, and enforcement with the need for legitimate access to
these drugs.
In developing a strategy to balance these priorities, the Administration
has worked to obtain better data on how people acquire and abuse controlled
pharmaceuticals. It is important to understand that there are distinct
differences between drugs such as heroin or marijuana and controlled
pharmaceuticals. As we know, illegal drugs such as cocaine, heroin,
and marijuana often are obtained through secretive and dangerous transactions.
Typical drug control strategies used to attack organizations that
focus on distribution of clandestine drugs do not necessarily lend
themselves to attacking those organizations that illegally traffic
in controlled pharmaceuticals.
Controlled pharmaceuticals are readily available for legitimate purposes
through one's physician and pharmacy. Distribution channels that are
otherwise legal are often manipulated to acquire controlled substance
prescription drugs for illegal purposes.
Compounding this matter is the perception, particularly among teenagers
and young adults that controlled pharmaceuticals are safe even when
used "recreationally." Abusers of controlled pharmaceuticals are using
these medicines for non-medical purposes in a manner for which they
were never intended. This practice, coupled with the erroneous perception
of safety, makes these medicines much more dangerous.
DEA Initiatives
DEA has not remained idle in response to this growing threat. DEA
has made it a priority to disrupt and dismantle organizations that
illegally traffic in controlled pharmaceuticals. This priority is
reflected in the fact that diversion control is a strategic goal in
the DEA five-year Strategic Plan. Part of this strategy is to attack
the economic basis of the drug trade by inflicting upon the illicit
drug business what every legal business fears: escalating costs, diminishing
profits, and unreliable suppliers. To do so, DEA uses all of the tools
at its disposal. We have dismantled major pharmaceutical trafficking
and distribution organizations through criminal investigations. We
have also used our regulatory authority to take action against DEA
registrants found to be in violation of regulatory requirements under
the CSA. Through regulatory authority, DEA has subjected registrants
to significant civil fines, licensing restrictions, or even suspended
registrations. Such civil remedies have proven to be an effective
deterrent to potential violators.
As we have observed the pharmaceutical controlled substances abuse
problem grow, DEA has significantly increased the amount of resources
and manpower dedicated to investigating the diversion of controlled
pharmaceuticals. We continue to focus our drug enforcement efforts
on the most significant diverters in the drug supply chain. Specifically,
DEA has increased the number of Special Agent work-hours on diversion
investigations by 114 percent between FY-2003 and FY-2005. DEA has
increased the number of Intelligence Analyst work-hours by 234 percent
during that same period.
Enforcement efforts undertaken by the DEA are also aimed at the economic
base of drug traffickers, and strong emphasis is placed on seizures
of financial and other assets. In FY- 2002 DEA seized approximately
$1.8 million in assets related to diversion investigations. In FY-2005
that increased to approximately $32.4 million, an 1,800 percent increase.
In early FY 2005, the DEA began working with its industry partners
to develop public service announcements that now appear automatically
during Internet prescription drug searches. These announcements are
designed to alert consumers of the potential dangers and the illegality
of purchasing controlled substances, particularly pharmaceuticals,
over the Internet. Both Yahoo and Google have responded by instituting
voluntary compliance measures and corporate commitments to taking
affirmative steps to curtail the illicit sale of pharmaceuticals on
their networks.
In addition, DEA's Demand Reduction office has produced an anti- drug
website for teens, www.justthinktwice.com.
This site provides young people with straightforward information on
the consequences of drug use and trafficking, including health, social,
legal consequences. It is continually updated to provide current information
to teens and will be expanded and refined to reflect the needs of
teens. This site has been a valuable (and popular) resource for teens
seeking information on drugs for their own education or for school
research projects. The Demand Reduction Program also continues to
provide the public and school age children with a variety of demand
reduction presentations on a national and local level regarding the
abuse of controlled prescriptions.
Finally, the DEA has met with the leading certifying medical boards
and encouraged them to develop educational programs concerning the
prescribing of controlled substances, especially high-dose opioids.
Sources of Abused Pharmaceuticals
Pharmaceutical investigations and surveys of state and local law enforcement
agencies and state medical boards have revealed that the most common
methods of controlled substance prescription drug diversion include
"doctor shopping" or other prescription fraud, illegal online pharmacies,
theft and burglary (from residences, pharmacies, etc.), stereotypical
drug dealing (selling pills to others), receiving from friends or
family, and negligent or intentional over-prescribing by physicians
or other practitioners. What is not yet adequately understood is the
relative proportion of these methods.
Doctor Shopping and Prescription Fraud
"Doctor shopping" by drug addicts is one of the most common ways that
addicts get illegal controlled substances. Generally, this term refers
to the visit by an individual--who may or may not have legitimate
medical needs--to several doctors, each of whom writes a prescription
for a controlled substance. The individual will visit several pharmacies,
receiving more of the drug than intended by any single physician,
typically for the purpose of feeding an addiction.
Associated illegal activities may include the forgery of prescriptions,
or the sale or transfer of the drug to others. Unfortunately, in many
states, physicians and pharmacists have not been able to automatically
cross-check multiple prescriptions given to the same patient.
To address this problem, Congress first appropriated funds to the
Department of Justice in 2003 to promote the deployment of Prescription
Drug Monitoring Programs (PDMPs) by States. That commitment continues
as part of the Administration's National Drug Control Strategy for
2006. PDMPs help cut down on prescription fraud and doctor shopping
by giving physicians and pharmacists more complete information about
a patient's prescriptions for controlled substances.
While the specifics of these programs vary from state to state, they
generally share the characteristic of allowing prescribers (for example,
a physician) and dispensers (for example, a pharmacist) to input and
receive accurate and timely controlled substance prescription history
information while ensuring patient access to needed treatment. Most
states also have some mechanism for law enforcement to receive this
information in cases where criminal activity is suspected. Some states
also allow health care providers to use this information as a tool
for the early identification of patients at risk for addiction in
order to initiate appropriate medical interventions. In other states
the justice system can use this information to assist in the enforcement
of laws controlling the sale and use of controlled substance prescription
medication.
The PDMP program has steadily expanded through the Harold Rogers
Prescription Drug Monitoring Program, with a total of 33 states with
active or planned PDMPs as of July 1, 2006. These grants can be used
to implement or enhance PDMPs at the state level. The Administration
plans to continue its work with states that have PDMPs to obtain better
data as to the extent and nature of the controlled substance prescription
drug abuse threat, to encourage the expansion of the PDMP program
nationwide, and to share best practices information with states that
already have PDMPs (e.g., on cost effectiveness, the benefits to monitoring
all scheduled controlled substances, and measuring performance).
Improper Prescribing
Improper prescribing is another method of controlled substance diversion.
Improper prescribing differs from doctor shopping and prescription
fraud in that the latter situations, the abusers are attempting to
deceive or mislead the medical professionals who are doing their jobs
responsibly.
The overwhelming majority of prescribing in America is conducted responsibly.
Often these responsible doctors and pharmacists are the first to alert
law enforcement to potential prescription problems. However, the small
number of physicians who over prescribe controlled substances--carelessly
at best, knowingly at worst-- help supply America's second most widespread
drug addiction problem. Although the problem exists, the number of
physicians and pharmacists responsible for this problem is a very
small fraction (less than 1 percent) of those licensed to prescribe
and dispense controlled substances in the United States.
Sharing Among Family and Friends
As DEA increases its understanding of where abusers acquire prescription
drugs, preliminary data suggest that the most common method in which
controlled substance prescriptions are diverted may be through friends
and family. For example, a person with a lawful and genuine medical
need for a controlled substance may use only a portion of the prescribed
amount. A family member or friend may complain of similar symptoms,
and the former patient shares excess medication. Alternatively, for
someone addicted to controlled substance prescription drugs or to
an inquisitive youngster, the mere availability of unused controlled
substance prescriptions in the house may prove to be an irresistible
temptation.
The solution to this aspect of the problem lies both with the medical
community and the legitimate patient population. Greater educational
efforts are needed regarding quick and safe disposal of unused and
unneeded medications. Prescribers need to carefully consider the potential
for abuse of controlled substances and prescribe only the amount of
a controlled substance required medically. Patients must also be educated
about the legal and social ramifications of providing a controlled
substance to a friend or family member. It is not merely illegal,
but could feed, or lead to, an addiction, and place that loved one
in a life threatening situation.
Illegal Online Pharmacies
Perhaps the most potentially dangerous and increasingly used method
for the diversion of controlled pharmaceuticals is through the Internet.
As the number of Americans with Internet access has increased, so
too have opportunities for individuals to acquire controlled substance
prescription drugs over the Internet. There are strong societal benefits
to allowing individuals with a valid prescription to get their prescriptions
over the Internet, as long as the pharmacy that fills these prescriptions
is a legitimate one and there is a legitimate doctor-patient relationship.
This may be helpful in rural areas or for individuals who are homebound
due to illness or other factors. However, the anonymity of the Internet,
and the proliferation of websites that facilitate illicit transactions
in controlled substance pharmaceutical drugs, have given drug abusers
the ability to circumvent both the law and sound medical practice.
There are legitimate pharmacies that provide services over the Internet
and that operate well within the bounds of both the law and sound
medical practice. The National Association of Boards of Pharmacy has
established a registry of pharmacies that operate online and meet
certain criteria, including compliance with licensing and inspection
requirements of their state and each state to which they dispense
pharmaceuticals.
By contrast, other websites used by Internet facilitators will often
advertise themselves as pharmacies, but they do not operate in the
same manner as brick-andmortar pharmacies. Many of these websites
advertise controlled substances without a prescription, and none include
an in-person medical examination from a licensed physician.
Of particular concern is the cursory and abbreviated nature of the
medical interaction. Often, if there is any interaction with a medical
professional at all, the Internet facilitator will provide only a
cursory doctor consultation by computer or telephone for customers.
This brief interaction is not meant to elicit meaningful health information,
and is generally done by way of a "questionnaire" filled out by the
"patient" without any face-to-face meeting between the doctor and
the patient. Without this faceto- face interaction, it is not possible
for the doctor writing the prescription, who has never met the patient,
to verify the information provided by the individual and assess legitimate
medical need. This is particularly troubling in the context of youth
drug abuse. Unlike when the patient visits the doctor, a minor can
easily log onto a website and provide an inaccurate age.
Doctors, who are often paid by the number of prescriptions they sign
in these situations, have no incentive to spend time seeking additional
patient information. Law enforcement has discovered website-affiliated
doctors who sign hundreds or thousands of prescriptions a day. After
receiving the prescription from the doctor, the facilitator will then
submit the prescription to a cooperating pharmacy. Because there is
often no identifying information on these rogue websites, it is very
difficult for law enforcement to track any of the individuals behind
them.
The Administration is using all available tools to go after the operators
of these rogue Internet-facilitator websites. We are conducting investigations
and working to intercept controlled substance prescriptions illegally
sent into the United States through the mail system. For example,
the DEA's Internet investigation unit at its Special Operations Division
continues to coordinate Internet cases, and the DEA has issued a number
of immediate suspensions of the DEA registrations of doctors and pharmacies
operating illegally via the Internet. The Department of Justice has
prosecuted doctors and pharmacies who illegally distribute via the
Internet.
The tangible aspects of manufacturing, distributing, prescribing,
and dispensing pharmaceutical controlled substances remain squarely
under the jurisdiction of the CSA. Any legitimate transaction over
the Internet must be in compliance with these existing laws.
Additional clarification of the roles and responsibilities for professionals
seeking to use the Internet to meet the needs of clients would not
only allow us to more readily identify legitimate online pharmacies
and persons operating and promoting them, but it would also assist
in gathering information pointing to abuse patterns. Such clarification
would also help us investigate drug traffickers hiding behind the
facade of an otherwise legitimate practice.
Additionally, there exists no statutory definition of a valid "doctor/patient"
relationship. Finally, the penalties associated with the illegal sale
of Schedule III-V substances, which are those most commonly sold controlled
substances over the Internet, are not as significant as may be warranted.
States can play a significant role in addressing the problem of online
facilitators, particularly through PDMPs. As part of the Administration's
work with states regarding PDMPs over the next several years, states
will be encouraged to consider addressing, either by statute, regulation,
or interstate agreement, a number of scenarios that primarily involve
pharmacies dispensing or delivering controlled substance prescription
drugs to patients across state lines. To be effective, laws must be
updated to reflect the changing ways people live and in which business
is conducted.
Coordinating Regulatory Responsibilities
As the DEA fights against diversion and drug abuse across the nation,
the proper regulatory control of new pharmaceuticals is vital. Appropriate
control mechanisms are particularly important given the strength and
formulations of products as they become available to the consumer.
This is important to the DEA as we are seeing an overall increase
in the commercial dispersion of pharmaceuticals which results in a
significant increase of pharmaceutical doses available for diversion.
Understanding the differences- and the similarities-between prescription
drugs and controlled substances is an important aspect of evaluating
the causes and possible policy solutions regarding the rise in prescription
drug abuse.
Congress signaled its full recognition of the abuse potential of certain
prescription drugs in 1914, when it passed the Harrison Narcotic Act,
regulating the sale of opiates for the first time. With the passage
of the Federal Food, Drug and Cosmetic Act (FDCA) in 1938 and in subsequent
amendments, the United States Congress recognized the critical importance
of indicating the medically proven uses of prescription drugs for
legitimate medical needs.
The CSA is the legal foundation for the United States fight against
abuse of drugs and other substances. It was passed to minimize the
quantity of abuseable substances available to those likely to abuse
them, while providing for legitimate medical, scientific and industrial
needs for those substances in the United States. Control under the
CSA encompasses both licit and illicit substances and regulates chemicals
used in the clandestine production of controlled substances. The Department
of Justice (DOJ), through the DEA, and the Department of Health and
Human Services (HHS), through the FDA, both have a role in implementing
the CSA.
The CSA requires that substances be scheduled by a determination made
by the Attorney General, after a scientific and medical evaluation
and recommendation by the Secretary of HHS (See 21 USC 811(b)). Substances
with a substantial potential for abuse are considered for control
under Schedules II through V. Schedule II substances have the highest
abuse potential and dependence profiles with the most restrictive
regulatory requirements, while III through V drugs have progressively
less abuse potential and dependence profiles and are subjected to
less restrictive regulatory requirements.
The placement of a substance in a given schedule is based on its medical
use, safety, potential for abuse, or dependence liability, and consideration
of specific factors as listed in the CSA. For drug products containing
substances that are not already controlled under the CSA, as in the
case of new molecular entities, HHS will forward their scientific
and medical evaluation and a scheduling recommendation to the DEA.
FDA has the statutory responsibility to determine the safety and effectiveness
of new drug products for medical use in the United Sates. As a part
of their evaluation, FDA also examines the abuse potential of drug
products.
The CSA includes seven major control mechanisms. They are scheduling,
registration, quotas, records and reports, import and export authorizations,
security and investigational authority. These mechanisms allow DEA
to monitor and regulate a controlled substance and its movement: in
the case of the most potentially dangerous drugs, in Schedule II,
we register all persons who handle them; we inspect the documentation
of their distribution; we control their import and export; and we
control the amount produced, bought, sold, and otherwise transferred.
These controls have been extremely effective in preventing diversion
at the importer, manufacturer, and distributor levels. However, as
described earlier, the vast majority of diversion occurs at the retail
level, once the product is in the hands of practitioners and patients.
Conclusion
The diversion of pharmaceutical controlled substances continues to
be a significant challenge. Nevertheless, the DEA is committed to
using the necessary tools at its disposal to fight this growing problem
on all fronts, while simultaneously ensuring an uninterrupted supply
of pharmaceutical controlled substances for legitimate demands.
DEA's core competency, the disruption and dismantlement of drug trafficking
organizations impacting the United States, is an integral component
to the Synthetic Drug Control Strategy and we will continue to implement
this aspect of the Strategy with our inter-agency partners to combat
controlled substance pharmaceutical diversion.
Chairman Souder, Ranking Member Cummings, and distinguished Members
of the Subcommittee, thank you again for the opportunity to testify
before you today.
Prescription drug abuse is an increasing threat that we must face,
and DEA looks forward to working with you to address this important
issue. I'll be happy to answer any questions you may have.
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