[Congressional Record Volume 153, Number 51 (Friday, March 23, 2007)]
[Senate]
[Pages S3708-S3718]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. OBAMA (for himself and Mr. Burr):
S. 976. A bill to secure the promise of personalized medicine for all
Americans by expanding and accelerating genomic research and
initiatives to improve the accuracy of disease diagnosis, increase the
safety of drugs, and identify novel treatments; to the Committee on
Health, Education, Labor, and Pensions.
[[Page S3709]]
Mr. OBAMA. Mr. President, I rise today joined by my colleague Senator
Richard Burr, to reintroduce the Genomics and Personalized Medicine Act
of 2007. This bill will expand and accelerate scientific advancement in
the field of genomics, which is already beginning to change the
paradigm of medical practice as we know it, and has profound
implications for health and health care in this nation.
The ``miracles of medicine'' have been demonstrated since early man.
Many of the traditional medicines used today, such as aspirin and
morphine, are derivatives of plants ancient people used to treat
illnesses and injuries centuries ago. Since those ancient times, our
knowledge of medicine and disease has expanded tremendously. Today,
modern breakthroughs in the fields of genetics and genomics have
uncovered another layer of complexity in the way we treat and prevent
disease.
Over the past decade, we have unlocked many of the mysteries about
DNA and RNA, their structure, and how their code is translated into the
proteins that make up the tissues and organs of the human body.
Researchers have also made discoveries about the various functions of
DNA such as replication, genetic recombination and regulation, just to
name a few, and have developed the necessary technologies to do all of
this work.
This knowledge isn't just sitting in books on the shelf nor is it
confined to the work benches of laboratories. We have used these
research findings to pinpoint the causes of many diseases, such as
sickle cell anemia, cystic fibrosis, and chronic myelogenous leukemia.
Moreover, scientists have translated this genetic knowledge into
several treatments and therapies prompting a bridge between the
laboratory bench and the patient's bedside.
We've made so many achievements and come a long way in our
understanding and application of genetics knowledge. And yet, we are
just beginning to realize the full potential of this science to predict
the onset of disease, diagnose earlier, and develop therapies that can
treat or cure Americans from so many afflictions.
Just 4 years ago, scientists at the National Institutes of Health and
the Department of Energy reached another major landmark, with the
completion of the sequencing of the entire human genome, our genetic
blueprint described by many as the Holy Grail of biology and hailed as
one of the greatest scientific achievements to date.
The completion of the Human Genome Project has paved the way for a
more sophisticated understanding of disease causation. The HGP has
expanded focus from the science of genetics, which refers to the study
of single genes, to include genomics, which describes the study of all
the genes in an individual, as well as the interactions of those genes
with each other. The role environmental factors play in promoting
disease and the potential influence they have at the genetic level is
also an area of interest.
We know that all human beings are 99.9 percent identical in genetic
makeup, but differences in the remaining 0.1 percent hold important
clues about the causes of disease and response to drugs. Simply put,
the study of genomics will help us learn why some people get sick and
others do not, and use this information to better prevent and treat
disease.
The relatively new field of genomics is key to the practice of
personalized medicine. Personalized medicine is the use of genomic and
molecular data to better target the delivery of health care, facilitate
the discovery and clinical testing of new products, and help determine
a patient's predisposition to a particular disease or condition.
Personalized medicine represents a revolutionary and exciting change in
the fundamental approach and practice of medicine
Pharmacogenomics, or the study of how genes affect a person's
response to drugs, is a critical component of personalized medicine.
Currently, so-called blockbuster drugs are typically effective in only
40 to 60 percent of patients who take them. Other studies have found
that up to 15 percent of hospitalized patients experience a serious
adverse drug reaction, causing an estimated 100,000 deaths each year.
Pharmacogenomics has the potential to dramatically increase the
effectiveness and safety of drugs, both of which are major health care
concerns.
We have a growing number of examples of how pharmacogenomics research
has helped to save lives. For example, the chemotherapy Purinethol is a
lifesaver for kids with leukemia, but in some cases, patients suffer
severe, sometimes fatal, side effects. In the 1990's, researchers
identified the gene variant that prevents affected patients from
properly breaking down Purinethol, allowing doctors to screen patients
and adjust dosages for safer use of the drug.
Herceptin, another example, is a breast cancer drug that initially
failed in clinical trials. However, researchers discovered that 1 in 4
breast cancers have too many copies of a certain gene, which helps
cells grow, divide and repair themselves. Extra copies of this gene
cause uncontrolled and rapid growth resulting in tumor formation. As it
turns out, Herceptin is an effective drug for patients with this type
of cancer, with significantly improved survival for affected women.
Herceptin offers a clear illustration of the power of personalized
medicine and highlights the importance of incorporating genetic
analysis in the development and application of new therapies.
Realizing the promise of personalized medicine will require continued
Federal leadership and agency collaboration; expansion and acceleration
of genomics research; a capable genomics workforce; incentives to
encourage development of genomic tests and therapies; and greater
attention to the quality of genetic tests, direct-to-consumer
advertising and use of personal genomic information.
The Genomics and Personalized Medicine Act of 2007 will address many
of these issues. The bill requires the Secretary of the Department of
Health and Human Services to establish the Genomics and Personalized
Medicine Interagency Working Group to expand and accelerate genomics
research through enhanced communication, collaboration and integration
of relevant activities.
Genetic and genomics research will be expanded, to increase the
collection of data that will advance both fields, through the support
of the biobanking initiative aimed at increasing and improving genomic
screening tools, diagnostics and therapeutics. The Secretary will also
establish a national distributed database so data finding can be
shared.
This bill requests that the Secretary support efforts to improve the
adequacy of genetics and genomics training through modernized curricula
and review of relevant certifications, and by identifying alternative
education options such as distance or on-line learning programs. In
addition, the Secretary will promote initiatives to increase the
integration of genetics and genomics into all aspects of medical and
public health practice, with specific focus on training and guideline
development for providers without expertise or experience in the field
of genomics.
This bill also requests the National Academies of Science to formally
study the development of companion diagnostic tests and to provide
expert guidance about the level of incentives and potential approaches
to really move this area forward.
Last but not least, the bill focuses on the safety, efficacy and
availability of information about genetic tests, including
pharmacogenetic and pharmacogenomics tests. The Secretary will contract
with the Institute of Medicine to conduct a study and make
recommendations regarding Federal oversight and regulation of genetic
tests. After this study is complete, the Secretary will develop a
decision matrix to help determine which types of tests require review
and the level of review needed for such tests as well as the
responsible agency. The Secretary will also establish a specialty area
for molecular and biochemical genetics tests at CMS and direct a review
by the CDC of direct-to-consumer marketing practices.
In conclusion, we stand at this new and expansive frontier of
personalized medicine we must explore and test the hypotheses and
innovations in the area of genomics that can protect and promote our
health. Genomics holds unparalleled promise for public health and for
medicine, and the Genomics and Personalized Medicine Act of 2007 will
help us to fulfill this promise. I
[[Page S3710]]
urge my colleagues to support me in passing this critical legislation.
______
By Mr. WYDEN (for himself and Mr. Kerry):
S. 979. A bill to establish a Vote by Mail grant program; to the
Committee on Rules and Administration.
Mr. WYDEN. Mr. President, on Election Day 2006 in Tillamook County,
OR, 13 inches of rain fell. Roads were closed. Parts of the county
became unreachable. Governor Kulongoski declared a state of emergency.
And yet--70 percent of the voters in the county still cast their
ballots.
Why? Because Oregonians in Tillamook County and all over the State
cast their votes by mail.
Even without weather like this, folks in other States around the
country had trouble casting their votes.
In Denver, CO, hundreds of voters were turned away when the database
of registered voters crashed.
Nearly a quarter of precincts in Indianapolis, IN, resorted to paper
ballots when poll workers couldn't figure out how to connect optical
scan voting machines with the new touch-screen models.
In Johnson County, KS, poll workers used hand lotion to prevent the
county's touch-screen voting machines from spitting out cards.
In Missouri, poll workers were demanding photo identification despite
a court ruling barring the practice.
In Shaker Heights, OH, voters were turned from the polls when
electronic voting machines failed to work.
Voters in Washington State received phone calls instructing them to
vote at the wrong precinct.
A polling location in New Mexico received 150 ballots instead of
1,500.
The list goes on and on.
The point is, vote by mail has worked in Oregon and not just in this
election, but in every election it has been used.
It's a pretty simple system. Voters get their ballots in the mail.
Wherever and whenever they would like, right up to Election Day, voters
complete their ballots and return them.
Vote by mail makes polling place problems a thing of the past--no
more polls opening late and no more long lines.
There's no more confusion about whether you are on the voter rolls.
Either you get the ballot in the mail, or you don't and if you don't,
you have ample time to contact your election officials to sort it out.
Vote by mail dramatically reduces the chance of voter fraud. Trained
election officials match the signature on each ballot against the
signature on each voter's registration card and no ballot is processed
or counted until officials are satisfied that the two signatures match.
Vote by mail ensures a paper trail--each voter marks up their ballot
and sends it in. That ballot is counted and then becomes the paper
record used in the event of a recount.
There's less risk of voter intimidation and that's why a 2003 study
of Oregon voters showed that those groups that would likely be most
vulnerable to coercion, including the elderly, actually prefer vote by
mail.
Vote by mail leads to more educated voters. Because folks get their
ballots weeks before the election, they have the time they need to get
educated about the candidates and the issues, and deliberate in a way
not possible at a polling place.
And vote by mail generates costs savings that can be spent on other
priorities like education, law enforcement and roads. Because there is
no longer any need to transport equipment to polling stations and to
hire and train poll workers, Oregon has reduced its election-related
costs by 30 percent since implementing vote by mail.
I think the Oregon experience can be copied elsewhere and that's why
I am introducing my Vote by Mail Act of 2007 today, which creates a
three year, $18 million grant program to help states adopt vote by mail
election systems like the one that Oregon voters have been successfully
using for some time now.
To participate in the grant program, States must demonstrate that the
vote by mail system they intend to implement includes the same elements
that have made Oregon's system so successful, including a system for
recording electronically each voter's registration and signature and a
process for ensuring that the signature on each VBM ballot is verified
against that voter's electronically recorded signature. States that
decide to participate in the program have the option of adopting vote
by mail State-wide, within a group of selected counties, or even in a
single county. States transitioning to vote by mail State-wide will
receive $2 million. States transitioning to VBM less than State-wide
will receive $1 million.
I think that vote by mail will improve the elections in every State
that adopts it. But to be sure, my bill instructs the Government
Accountability Office to evaluate the benefits of vote by mail and to
produce a study comparing traditional voting methods and vote by mail.
I urge my colleagues to lend their support to the Vote by Mail Act of
2007. I believe it can help ensure hassle-free elections and help
rebuild confidence in our election system.
Because right now, some folks feel like they are so powerless to do
anything to fix things that they throw their hands in the air and walk
away. And society suffers. For democracies to work there needs to be
public engagement. But that requires a sense of investedness--unless I
think of the government as my government, which means it's considering
my interests and, more importantly, trying to solve them, it's pretty
hard to stay invested.
The sense of resignation, of frustration, even dislocation, expressed
by some folks troubles me. And I consider it my job to foster a greater
sense of public investment. This means making sure that the government
works for everyone and that there are tangible results that you can
show people so that they understand that it's their government and that
it works for them.
I think election reform like my vote by mail bill accomplishes this
goal at the most basic level. Without fair, trouble-free elections,
you've got serious problems. You don't even get past go. The public
can't have confidence in its government if it doesn't have confidence
in the system that elected that government. As we saw in 2000 in
Florida, it is extremely difficult to untangle problems after Election
Day so you really have to get it right the first time. Vote by mail
helps ensures this.
I am pleased to have my esteemed colleague from Massachusetts,
Senator Kerry as an original co-sponsor. I am also pleased that
Congresswoman Susan David of California is introducing the House
companion bill. I am also happy to announce that the American
Association of People with Disabilities, the American Postal Workers
Union, Common Cause, and the National Association of Postal Supervisors
are publicly supporting this bill.
I ask unanimous consent that the text of the bill be printed in the
Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 979
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Vote by Mail Act of 2007''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) The Supreme Court declared in Reynolds v. Sims that
``[i]t has been repeatedly recognized that all qualified
voters have a constitutionally protected right to vote . . .
and to have their votes counted.''.
(2) In the 2000 and 2004 presidential elections, voting
technology failures and procedural irregularities deprived
some Americans of their fundamental right to vote.
(3) In 2000, faulty punch card ballots and other equipment
failures prevented accurate vote counts nationwide. A report
by the Caltech/MIT Voting Technology Project estimates that
approximately 1,500,000 votes for president were intended to
be cast but not counted in the 2000 election because of
equipment failures.
(4) In 2004, software errors, malfunctioning electronic
voting systems, and long lines at the polls prevented
accurate vote counts and prevented some people from voting.
For instance, voters at Kenyon College in Gambier, Ohio
waited in line for up to 12 hours because there were only 2
machines available for 1,300 voters.
(5) In 2006, election day problems plagued voters in a
number of States as well. For instance, in Denver, Colorado,
hundreds of voters were turned away when the database of
registered voters crashed. In Allegheny County, Pennsylvania,
malfunctioning machines and an inadequate number of
provisional ballots generated long lines, causing many voters
to leave without casting a vote.
[[Page S3711]]
(6) Under the Oregon Vote by Mail system, election
officials mail ballots to all registered voters at least 2
weeks before election day. Voters mark their ballots, seal
the ballots in both unmarked secrecy envelopes and signed
return envelopes, and return the ballots by mail or to secure
drop boxes. Once a ballot is received, election officials
scan the bar code on the ballot envelope, which brings up the
voter's signature on a computer screen. The election official
compares the signature on the screen and the signature on the
ballot envelope. Only if the signature on the ballot envelope
is determined to be authentic is the ballot forwarded on to
be counted.
(7) Oregon's Vote by Mail system has deterred voter fraud
because the system includes numerous security measures such
as the signature authentication system. Potential misconduct
is also discouraged by the power of the State to punish those
who engage in voter fraud with up to five years in prison,
$100,000 in fines, and the loss of their vote.
(8) Oregon's Vote by Mail system promotes uniformity and
strict compliance with Federal and State voting laws because
ballot processing is centralized in county clerk's offices,
rather than at numerous polling places.
(9) Vote by Mail is one factor making voter turnout in
Oregon consistently higher than the average national voter
turnout. For example, Oregon experienced a record voting-age-
eligible population turnout of 70.6 percent in the 2004
presidential election, compared to 58.4 percent nationally.
Oregon's turnout of registered voters for that election was
86.48 percent.
(10) Women, younger voters, and homemakers also report that
they vote more often using Vote by Mail.
(11) Vote by Mail reduces election costs by eliminating the
need to transport equipment to polling stations and to hire
and train poll workers. Oregon has reduced its election-
related costs by 30 percent since implementing Vote by Mail.
(12) Vote by Mail allows voters to educate themselves
because they receive ballots well before election day, which
provides them with ample time to research issues, study
ballots, and deliberate in a way that is not possible at a
polling place.
(13) Vote by Mail is accurate--at least 2 studies comparing
voting technologies show that absentee voting methods,
including Vote by Mail systems, result in a more accurate
vote count.
(14) Vote by Mail results in more up-to-date voter rolls,
since election officials use forwarding information from the
post office to update voter registration.
(15) Vote by Mail allows voters to visually verify that
their votes were cast correctly and produces a paper trail
for recounts.
(16) In a survey taken 5 years after Oregon implemented the
Vote by Mail system, more than 8 in 10 Oregon voters said
they preferred voting by mail to traditional voting.
SEC. 3. DEFINITIONS.
In this Act:
(1) Election.--The term ``election'' means any general,
special, primary, or runoff election.
(2) Participating state.--The term ``participating State''
means a State receiving a grant under the Vote by Mail grant
program under section 4.
(3) Residual vote rate.--The term ``residual vote rate''
means the sum of all votes that cannot be counted in an
election (overvotes, undervotes, and otherwise spoiled
ballots) divided by the total number of votes cast.
(4) State.--The term ``State'' means a State of the United
States, the District of Columbia, the Commonwealth of Puerto
Rico, or a territory or possession of the United States.
(5) Voting system.--The term ``voting system'' has the
meaning given such term under section 301(b) of the Help
America Vote Act of 2002 (42 U.S.C. 15481(b)).
SEC. 4. VOTE BY MAIL GRANT PROGRAM.
(a) Establishment.--Not later than 270 days after the date
of enactment of this Act, the Election Assistance Commission
shall establish a Vote by Mail grant program (in this section
referred to as the ``program'').
(b) Purpose.--The purpose of the program is to make
implementation grants to participating States solely for the
implementation of procedures for the conduct of all elections
by mail at the State or local government level.
(c) Limitation on Use of Funds.--In no case may grants made
under this section be used to reimburse a State for costs
incurred in implementing mail-in voting for elections at the
State or local government level if such costs were incurred
prior to the date of enactment of this Act.
(d) Application.--A State seeking to participate in the
program under this section shall submit an application to the
Election Assistance Commission containing such information,
and at such time, as the Election Assistance Commission may
specify.
(e) Amount and Awarding of Implementation Grants; Duration
of Program.--
(1) Amount of implementation grants.--
(A) In general.--Subject to subparagraph (B), the amount of
an implementation grant made to a participating State shall
be, in the case of a State that certifies that it will
implement all elections by mail in accordance with the
requirements of subsection (f), with respect to--
(i) the entire State, $2,000,000; or
(ii) any single unit or multiple units of local government
within the State, $1,000,000.
(B) Excess funds.--
(i) In general.--To the extent that there are excess funds
in either of the first 2 years of the program, such funds may
be used to award implementation grants to participating
States in subsequent years.
(ii) Excess funds defined.--For purposes of clause (i), the
term ``excess funds'' means any amounts appropriated pursuant
to the authorization under subsection (h)(1) with respect
to a fiscal year that are not awarded to a participating
State under an implementation grant during such fiscal
year.
(C) Continuing availability of funds after appropriation.--
An implementation grant made to a participating State under
this section shall be available to the State without fiscal
year limitation.
(2) Awarding of implementation grants.--
(A) In general.--The Election Assistance Commission shall
award implementation grants during each year in which the
program is conducted.
(B) One grant per state.--The Election Assistance
Commission shall not award more than 1 implementation grant
to any participating State under this section over the
duration of the program.
(3) Duration.--The program shall be conducted for a period
of 3 years.
(f) Requirements.--
(1) Required procedures.--A participating State shall
establish and implement procedures for conducting all
elections by mail in the area with respect to which it
receives an implementation grant to conduct such elections,
including the following:
(A) A process for recording electronically each voter's
registration information and signature.
(B) A process for mailing ballots to all eligible voters.
(C) The designation of places for the deposit of ballots
cast in an election.
(D) A process for ensuring the secrecy and integrity of
ballots cast in the election.
(E) Procedures and penalties for preventing election fraud
and ballot tampering, including procedures for the
verification of the signature of the voter accompanying the
ballot through comparison of such signature with the
signature of the voter maintained by the State in accordance
with subparagraph (A).
(F) Procedures for verifying that a ballot has been
received by the appropriate authority.
(G) Procedures for obtaining a replacement ballot in the
case of a ballot which is destroyed, spoiled, lost, or not
received by the voter.
(H) A plan for training election workers in signature
verification techniques.
(I) Plans and procedures to ensure that voters who are
blind, visually-impaired, or otherwise disabled have the
opportunity to participate in elections conducted by mail and
to ensure compliance with the Help America Vote Act of 2002.
Such plans and procedures shall be developed in consultation
with disabled and other civil rights organizations, voting
rights groups, State election officials, voter protection
groups, and other interested community organizations.
(J) Plans and procedures to ensure the translation of
ballots and voting materials in accordance with section 203
of the Voting Rights Act of 1965 (42 U.S.C. 1973aa-1a)).
(g) Best Practices, Technical Assistance, and Reports.--
(1) In general.--The Election Assistance Commission shall--
(A) develop, periodically issue, and, as appropriate,
update best practices for conducting elections by mail;
(B) provide technical assistance to participating States
for the purpose of implementing procedures for conducting
elections by mail; and
(C) submit to the appropriate committees of Congress--
(i) annual reports on the implementation of such procedures
by participating States during each year in which the program
is conducted; and
(ii) upon completion of the program conducted under this
section, a final report on the program, together with
recommendations for such legislation or administrative action
as the Election Assistance Commission determines to be
appropriate.
(2) Consultation.--In developing, issuing, and updating
best practices, developing materials to provide technical
assistance to participating States, and developing the annual
and final reports under paragraph (1), the Election
Assistance Commission shall consult with interested parties,
including--
(A) State and local election officials;
(B) the United States Postal Service;
(C) the Postal Regulatory Commission established under
section 501 of title 39, United States Code; and
(D) voting rights groups, voter protection groups, groups
representing the disabled, and other civil rights or
community organizations.
(h) Authorization of Appropriations.--
(1) Grants.--There are authorized to be appropriated to
award grants under this section, for each of fiscal years
2007 through 2009, $6,000,000, to remain available without
fiscal year limitation until expended.
(2) Administration.--There are authorized to be
appropriated to administer the program under this section,
$200,000 for the period of fiscal years 2007 through 2009, to
remain available without fiscal year limitation until
expended.
(i) Rule of Construction.--Nothing in this Act may be
construed to authorize or require
[[Page S3712]]
conduct prohibited under any of the following laws, or to
supersede, restrict, or limit the application of such laws:
(1) The Help America Vote Act of 2002 (42 U.S.C. 15301 et
seq.).
(2) The Voting Rights Act of 1965 (42 U.S.C. 1973 et seq.).
(3) The Voting Accessibility for the Elderly and
Handicapped Act (42 U.S.C. 1973ee et seq.).
(4) The Uniformed and Overseas Citizens Absentee Voting
Act(42 U.S.C. 1973ff et seq.).
(5) The National Voter Registration Act of 1993 (42 U.S.C.
1973gg et seq.).
(6) The Americans with Disabilities Act of 1990 (42 U.S.C.
12101 et seq.).
(7) The Rehabilitation Act of 1973 (29 U.S.C. 701 et seq.).
SEC. 5. STUDY ON IMPLEMENTATION OF MAIL-IN VOTING FOR
ELECTIONS.
(a) Study.--
(1) In general.--The Comptroller General of the United
States (in this section referred to as the ``Comptroller
General'') shall conduct a study evaluating the benefits of
broader implementation of mail-in voting in elections, taking
into consideration the annual reports submitted by the
Election Assistance Commission under section 4(g)(1)(C)(i)
before November 1, 2009.
(2) Specific issues studied.--The study conducted under
paragraph (1) shall include a comparison of traditional
voting methods and mail-in voting with respect to--
(A) the likelihood of voter fraud and misconduct;
(B) the accuracy of voter rolls;
(C) the accuracy of election results;
(D) voter participation in urban and rural communities and
by minorities, language minorities (as defined in section 203
of the Voting Rights Act of 1965 (42 U.S.C. 1973aa-1a)), and
individuals with disabilities and by individuals who are
homeless or who frequently change their official residences;
(E) public confidence in the election system;
(F) the residual vote rate, including such rate based on
voter age, education, income, race, or ethnicity or whether a
voter lives in an urban or rural community, is disabled, or
is a language minority (as so defined); and
(G) cost savings.
(3) Consultation.--In conducting the study under paragraph
(1), the Comptroller General shall consult with interested
parties, including--
(A) State and local election officials;
(B) the United States Postal Service;
(C) the Postal Regulatory Commission established under
section 501 of title 39, United States Code; and
(D) voting rights groups, voter protection groups, groups
representing the disabled, and other civil rights or
community organizations.
(b) Report.--Not later than November 1, 2009, the
Comptroller General shall prepare and submit to the
appropriate committees of Congress a report on the study
conducted under subsection (a), together with such
recommendations for legislation or administrative action as
the Comptroller General determines to be appropriate.
______
By Mrs. FEINSTEIN (for herself and Mr. Sessions):
S. 980. A bill to amend the Controlled Substances Act to address
online pharmacies; to the Committee on the Judiciary.
Mrs. FEINSTEIN. Mr. President, I am pleased to join with Senator
Sessions to re-introduce the Online Pharmacy Consumer Protection Act.
Our legislation protects the safety of consumers who wish to fill
legitimate prescriptions over the Internet, while holding accountable
those who operate unregistered pharmacies.
This legislation imposes basic, commonsense requirements on an
industry that presents both promise and peril.
First, this bill establishes disclosure standards for Internet
pharmacies.
Second, this bill prohibits an Internet pharmacy from dispensing or
selling a controlled substance without an in-person examination by a
physician.
Third, it allows a State Attorney General to bring a civil action in
a federal district court to enjoin a pharmacy operating in violation of
the law, and to enforce compliance with the provisions of this law.
The disclosure requirements contained in this bill will allow
patients to differentiate between shady off-shore pharmacies and
legitimate licensed ones. Under this legislation, pharmacies must
clearly disclose: the name and address of the pharmacy. Contact
information for the pharmacist-in-charge. A list of States in which the
pharmacy is licensed to operate.
They must also clearly post a statement that they comply with the
requirements in this legislation.
The bill states that pharmacies can dispense to patients only if they
have a valid prescription from a practitioner who has performed an in-
person examination. This requirement will ensure that doctors can
verify the health status of a patient and ensure that the drug he or
she will receive from the pharmacy is medically appropriate.
This legislation recognizes that in the case of an emergency, a
patient may not always be able to see his or her typical physician. For
that reason, it allows a doctor to designate a covering practitioner to
write a valid prescription if he or she is not available.
Finally, this bill contains real penalties to hold accountable those
who continue to operate pharmacies in violation of these requirements.
First, for Internet sales of controlled substances, the bill makes
clear that such activities are subject to the current Federal laws
against illegal distributions and the same penalties applicable to
hand-to-hand sales.
Second, the bill increases the penalties for illegal distributions of
controlled substances categorized by the DEA as Schedule III, IV and V
substances, with new penalties if death or serious bodily injury
results, and longer periods of supervised release available after
convictions.
The bill also allows a State's Attorney General to file a Federal
motion to stop these pharmacies from operating illegally, no matter
where the entity is headquartered. Previously, this type of enforcement
would require a filing in every state.
Prescription drug abuse is a growing front on the War on Drugs, with
15.1 million adults admitting to abuse of prescription drugs in a 2003
study. That's a 94 percent increase in the last decade.
Last month, the Centers for Disease Control and Prevention reported
that deaths from accidental drug overdoses nearly doubled from 1999 to
2004, increasing from 11,155 in 1999 to 19,838 in 2004. Accidental drug
overdoses are now the Nation's second-leading cause of accidental
death, behind automobile crashes.
The CDC attributed the rise in drug overdose deaths to a higher use
of prescription painkillers and increasing numbers of overdoses of
cocaine and prescription sedatives. These increases did not occur in
our inner cities; instead, the increase was described as being fueled
by prescription drug abuse in middle-class, rural America--with
overdose death rates doubling in 23 States, mostly in the South and
Midwest.
Ready access to controlled substances over the Internet is helping to
fuel these addictions. A study conducted by the National Center on
Addiction and Substance Abuse at Columbia University found at least 344
websites offering controlled substances.
89 percent of these pharmacies do not require a prescription from a
physician, accepting either an online consultation or no prescription
at all.
38 percent of these pharmacies claim their drugs are shipping within
the United States, putting them within the reach of U.S. law
enforcement.
We also know that internet pharmacies fill a disproportionate number
of prescriptions for controlled substances. According to data from the
National Community Pharmacy Association (NCPA)-Pfizer Digest,
controlled substances account for only 11 percent of the business at
community ``brick and mortar'' pharmacies. 89 percent of their business
consists of non-controlled prescription drugs. In contrast,
approximately 95 percent of the business done by internet pharmacies is
controlled substances.
To understand how many of these Internet pharmacy websites exist,
just visit any Internet search engine. Type in the name of any
controlled substance, like Vicodin, Oxycontin, codeine, or even
anabolic steroids. Several websites will appear, offering to sell you
these drugs without a prescription and without a medical examination.
Some of these websites simply ask patients to send copies of medical
records, with no verification of their validity. Patients use these
pharmacies to obtain addictive drugs like Vicodin and Oxycontin. They
can receive these dangerous drugs without a doctor performing a
physical exam to ensure that an underlying health condition will not
cause a dangerous side effect. Often, a credit card is all that is
required.
Law enforcement officials are well aware of this growing problem but
face many challenges in trying to find and prosecute rogue pharmacy
operators. Last year, Attorney General Alberto Gonzales appeared before
the Senate Judiciary Committee and warned at
[[Page S3713]]
that time how ``the purchase of . . . controlled pharmaceuticals on the
Internet is of great concern.'' He said that the Internet's wide
accessibility and anonymity ``give drug abusers the ability to
circumvent the law, as well as sound medical practice, a[s] they
dispense potentially dangerous controlled pharmaceuticals,'' and said
that, with ``no identifying . . . information on these websites, it is
very difficult for law enforcement to track any of the individuals
behind them.''
In January of this year, Attorney General Alberto Gonzales again
appeared before the Senate Judiciary Committee. The problem had only
grown worse. He described the non-medicinal use of controlled substance
prescription drugs as ``the fastest rising category of drug abuse in
recent years.'' He noted how ``[r]ogue pharmacies operating illicitly
through the Internet increasingly have become a source for the illegal
supply of controlled substances,'' and offered to work with Congress to
try to adopt additional enforcement tools that may be appropriate.
I believe that the bill I introduce today will address many of these
problems that the Attorney General has identified.
At the same time, receiving medications from a legitimate, licensed
Internet pharmacy is one of the new conveniences ushered in by the
Internet age. This bill preserves the ability of well run pharmacies
and well intentioned patients to access controlled substances by means
of the Internet.
In closing, I want to share with you the story of Ryan T. Haight of
La Mesa, CA. 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 is just one of many. Internet pharmacies are making it
increasingly easy for teens like Ryan to access deadly prescription
drugs. That is why I support this legislation. It creates sensible
requirements for Internet pharmacy websites that will not impact access
to convenient, oftentimes cost-saving drugs.
I urge my colleagues to join me in supporting this legislation and I
ask unanimous consent that the text of the legislation be printed in
the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
S. 980
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Online Pharmacy Consumer
Protection Act of 2007''.
SEC. 2. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING
TO THE DELIVERY OF CONTROLLED SUBSTANCES BY
MEANS OF THE INTERNET.
(a) In General.--Section 102 of the Controlled Substances
Act (21 U.S.C. 802) is amended by adding at the end the
following:
``(47) The term `Internet' means collectively the myriad of
computer and telecommunications facilities, including
equipment and operating software, which comprise the
interconnected worldwide network of networks that employ the
Transmission Control Protocol/Internet Protocol, or any
predecessor or successor protocol to such protocol, to
communicate information of all kinds by wire or radio.
``(48) The term `deliver, distribute, or dispense by means
of the Internet' refers, respectively, to any delivery,
distribution, or dispensing of a controlled substance that is
caused or facilitated by means of the Internet.
``(49) The term `online pharmacy'--
``(A) means a person, entity, or Internet site, whether in
the United States or abroad, that delivers, distributes, or
dispenses, or offers to deliver, distribute, or dispense, a
controlled substance by means of the Internet; and
``(B) does not include--
``(i) manufacturers or distributors registered under
subsection (a), (b), (c), or (d) of section 303 who do not
dispense controlled substances;
``(ii) nonpharmacy practitioners who are registered under
section 303(f);
``(iii) mere advertisements that do not attempt to
facilitate an actual transaction involving a controlled
substance; or
``(iv) a person, entity, or Internet site which is not in
the United States and does not facilitate the delivery,
distribution, or dispensing of a controlled substance by
means of the Internet to any person in the United States.
``(50) The term `homepage' means the first page of the
website of an online pharmacy that is viewable on the
Internet.''.
(b) Registration Requirements.--Section 303 of the
Controlled Substances Act (21 U.S.C. 823) is amended by
adding at the end the following new subsection:
``(i) Dispenser of Controlled Substances by Means of the
Internet.--(1) A pharmacy that seeks to deliver, distribute,
or dispense by means of the Internet a controlled substance
shall obtain a registration specifically authorizing such
activity, in accordance with regulations promulgated by the
Attorney General. In determining whether to grant an
application for such registration, the Attorney General shall
apply the factors set forth in subsection (f).
``(2) Registration under this subsection shall be in
addition to, and not in lieu of, registration under
subsection (f).
``(3) This subsection does not apply to pharmacies that
merely advertise by means of the Internet but do not attempt
to facilitate an actual transaction involving a controlled
substance by means of the Internet.''.
(c) Reporting Requirements.--Section 307(d) of the
Controlled Substances Act (21 U.S.C. 827(d)) is amended by--
(1) designating the text as paragraph (1); and
(2) inserting after paragraph (1), as so designated by this
Act, the following new paragraph:
``(2) A pharmacy registered under section 303(i) shall
report to the Attorney General the controlled substances
dispensed under such registration, in such manner and
accompanied by such information as the Attorney General by
regulation shall require.''.
(d) Online Prescription Requirement.--Section 309 of the
Controlled Substances Act (21 U.S.C. 829) is amended by
adding at the end the following new subsection:
``(e) Controlled Substances Dispensed by Means of the
Internet.--(1) As used in this subsection--
``(A) the term `valid prescription' means a prescription
that is issued for a legitimate medical purpose in the usual
course of professional practice that is based upon a
qualifying medical relationship by a practitioner registered
by the Attorney General under this part;
``(B) the term `qualifying medical relationship'--
``(i) means a medical relationship that exists when the
practitioner--
``(I) has conducted at least one medical evaluation with
the user in the physical presence of the practitioner,
without regard to whether portions of the evaluation are
conducted by other health professionals; or
``(II) conducts a medical evaluation of the patient as a
covering practitioner and is not prescribing a controlled
substance in schedule II, III, or IV; and
``(ii) shall not be construed to imply that one medical
evaluation described in clause (i) demonstrates that a
prescription has been issued for a legitimate medical purpose
within the usual course of professional practice; and
``(C) the term `covering practitioner' means, with respect
to a patient, a practitioner who conducts a medical
evaluation, without regard to whether the medical evaluation
of the patient involved is an in-person evaluation, at the
request of a practitioner who has conducted at least one in-
person medical evaluation of the patient and is temporarily
unavailable to conduct the evaluation of the patient.
``(2) In addition to the requirements of subsections (a)
through (c), no controlled substance may be delivered,
distributed, or dispensed by means of the Internet without a
valid prescription.
``(3) Nothing in this subsection shall apply to--
``(A) the dispensing of a controlled substance pursuant to
telemedicine practices sponsored by--
``(i) a hospital that has in effect a provider agreement
under title XVIII of the Social Security Act; or
``(ii) a group practice that has not fewer than 100
physicians who have in effect provider agreements under such
title; or
``(B) the dispensing or selling of a controlled substance
pursuant to practices as determined by the Attorney General
by regulation.''.
(e) Online Prescription Requirements.--The Controlled
Substances Act is amended by adding after section 310 (21
U.S.C. 830) the following:
``ONLINE PHARMACY LICENSING AND DISCLOSURE REQUIREMENTS
``Sec. 311. (a) In General.--An online pharmacy shall
display in a visible and clear manner on its homepage a
statement that it complies with the requirements of this
section with respect to the delivery or sale or offer for
sale of controlled substances and shall at all times display
on the homepage of its Internet site a declaration of
compliance in accordance with this section.
``(b) Licensure.--Each online pharmacy shall comply with
the requirements of State law concerning the licensure of
pharmacies
[[Page S3714]]
in each State from which it, and in each State to which it,
delivers, distributes, or dispenses or offers to deliver,
distribute, or dispense controlled substances by means of the
Internet.
``(c) Compliance.--No online pharmacy or practitioner shall
deliver, distribute, or dispense by means of the Internet a
controlled substance without a valid prescription (as defined
in section 309(e)) and each online pharmacy shall comply with
all applicable requirements of Federal and State law.
``(d) Internet Site Disclosure Information.--Each online
pharmacy site shall post in a visible and clear manner on the
homepage of its Internet site or on a page directly linked
from its homepage the following:
``(1) The name of the owner, street address of the online
pharmacy's principal place of business, telephone number, and
email address.
``(2) A list of the States in which the online pharmacy,
and any pharmacy which dispenses, delivers, or distributes a
controlled substance on behalf of the online pharmacy, is
licensed to dispense controlled substances or prescription
drugs and any applicable license number.
``(3) For each pharmacy identified on its license in each
State in which it is licensed to engage in the practice of
pharmacy and for each pharmacy which dispenses or ships
controlled substances on behalf of the online pharmacy:
``(A) The name of the pharmacy.
``(B) The street address of the pharmacy.
``(C) The name, professional degree, and licensure of the
pharmacist-in-charge.
``(D) The telephone number at which the pharmacist-in-
charge can be contacted.
``(E) A certification that each pharmacy which dispenses or
ships controlled substances on behalf of the online pharmacy
is registered under this part to deliver, distribute, or
dispense by means of the Internet controlled substances.
``(4) The name, address, professional degree, and licensure
of practitioners who provide medical consultations through
the website for the purpose of providing prescriptions.
``(5) A telephone number or numbers at which the
practitioners described in paragraph (4) may be contacted.
``(6) The following statement, unless revised by the
Attorney General by regulation: `This online pharmacy will
only dispense a controlled substance to a person who has a
valid prescription issued for a legitimate medical purpose
based upon a medical relationship with a prescribing
practitioner, which includes at least one prior in-person
medical evaluation. This online pharmacy complies with
section 309(e) of the Controlled Substances Act (21 U.S.C.
829(e)).'.
``(e) Notification.--(1) Thirty days prior to offering a
controlled substance for sale, delivery, distribution, or
dispensing, the online pharmacy shall notify the Attorney
General, in the form and manner as the Attorney General shall
determine, and the State boards of pharmacy in any States in
which the online pharmacy offers to sell, deliver,
distribute, or dispense controlled substances.
``(2) The notification required under paragraph (1) shall
include--
``(A) the information required to be posted on the online
pharmacy's Internet site under subsection (d) and shall
notify the Attorney General and the applicable State boards
of pharmacy, under penalty of perjury, that the information
disclosed on its Internet site under to subsection (d) is
true and accurate;
``(B) the online pharmacy's Internet site address and a
certification that the online pharmacy shall notify the
Attorney General of any change in the address at least 30
days in advance; and
``(C) the Drug Enforcement Administration registration
numbers of any pharmacies and practitioners referred to in
subsection (d), as applicable.
``(3) An online pharmacy that is already operational as of
the effective date of this section, shall notify the Attorney
General and applicable State boards of pharmacy in accordance
with this subsection not later than 30 days after the
effective date of this section.
``(f) Declaration of Compliance.--On and after the date on
which it makes the notification under subsection (e), each
online pharmacy shall display on the homepage of its Internet
site, in such form as the Attorney General shall by
regulation require, a declaration that it has made such
notification to the Attorney General.
``(g) Reports.--Any statement, declaration, notification,
or disclosure required under this section shall be considered
a report required to be kept under this part.''.
(f) Offenses Involving Controlled Substances in Schedules
III, IV, and V.--Section 401(b) of the Controlled Substances
Act (21 U.S.C. 841(b)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by striking ``1 gram of'' before
``flunitrazepam'';
(B) in subparagraph (D), by striking ``or in the case of
any controlled substance in schedule III (other than gamma
hydroxybutyric acid), or 30 milligrams of flunitrazepam'';
and
(C) by inserting at the end the following:
``(E)(i) In the case of any controlled substance in
schedule III, such person shall be sentenced to a term of
imprisonment of not more than 10 years and if death or
serious bodily injury results from the use of such substance
shall be sentenced to a term of imprisonment of not more than
20 years, a fine not to exceed the greater of that authorized
in accordance with the provisions of title 18, or $500,000 if
the defendant is an individual or $2,500,000 if the defendant
is other than an individual, or both.
``(ii) If any person commits such a violation after a prior
conviction for a felony drug offense has become final, such
person shall be sentenced to a term of imprisonment of not
more than 20 years and if death or serious bodily injury
results from the use of such substance shall be sentenced to
a term of imprisonment of not more than 30 years, a fine not
to exceed the greater of twice that authorized in accordance
with the provisions of title 18, or $1,000,000 if the
defendant is an individual or $5,000,000 if the defendant is
other than an individual, or both.
``(iii) Any sentence imposing a term of imprisonment under
this subparagraph shall, in the absence of such a prior
conviction, impose a term of supervised release of at least 2
years in addition to such term of imprisonment and shall, if
there was such a prior conviction, impose a term of
supervised release of at least 4 years in addition to such
term of imprisonment'';
(2) in paragraph (2) by--
(A) striking ``3 years'' and inserting ``5 years'';
(B) striking ``6 years'' and inserting ``10 years'';
(C) striking ``after one or more prior convictions'' and
all that follows through ``have become final,'' and inserting
``after a prior conviction for a felony drug offense has
become final,''; and
(3) in paragraph (3) by--
(A) striking ``2 years'' and inserting ``6 years'';
(B) striking ``after one or more convictions'' and all that
follows through ``have become final,'' and inserting ``after
a prior conviction for a felony drug offense has become
final,''; and
(C) adding at the end the following ``Any sentence imposing
a term of imprisonment under this paragraph may, if there was
a prior conviction, impose a term of supervised release of
not more than 1 year, in addition to such term of
imprisonment.''
(g) Offenses Involving Dispensing of Controlled Substances
by Means of the Internet.--Section 401 of the Controlled
Substances Act (21 U.S.C. 841) is amended by adding at the
end the following:
``(g) Offenses Involving Dispensing of Controlled
Substances by Means of the Internet.--(1) Except as
authorized by this title, it shall be unlawful for any person
to knowingly or intentionally cause or facilitate the
delivery, distribution, or dispensing by means of the
Internet of a controlled substance.
``(2) Violations of this subsection include--
``(A) delivering, distributing, or dispensing a controlled
substance by means of the Internet by a pharmacy not
registered under section 303(i);
``(B) writing a prescription for a controlled substance for
the purpose of delivery, distribution, or dispensation by
means of the Internet in violation of subsection 309(e);
``(C) serving as an agent, intermediary, or other entity
that causes the Internet to be used to bring together a buyer
and seller to engage in the dispensing of a controlled
substance in a manner not authorized by sections 303(i) or
309(e); and
``(D) making a material false, fictitious, or fraudulent
statement or representation in the submission to the Attorney
General under section 311.
``(3) This subsection does not apply to--
``(A) the delivery, distribution, or dispensation of
controlled substances by nonpractitioners to the extent
authorized by their registration under this title;
``(B) the placement on the Internet of material that merely
advocates the use of a controlled substance or includes
pricing information without attempting to propose or
facilitate an actual transaction involving a controlled
substance; or
``(C) any activity that is limited to--
``(i) the provision of a telecommunications service, or of
an Internet access service or Internet information location
tool (as those terms are defined in section 231 of the
Communications Act of 1934 (47 U.S.C. 231)); or
``(ii) the transmission, storage, retrieval, hosting,
formatting, or translation (or any combination thereof) of a
communication, without selection or alteration of the content
of the communication, except that deletion of a particular
communication or material made by another person in a manner
consistent with section 230(c) of the Communications Act of
1934 (47 U.S.C. 230(c)) shall not constitute such selection
or alteration of the content of the communication.
``(4) Any person who knowingly or intentionally violates
this subsection shall be sentenced in accordance with
subsection (b) of this section.''.
(h) Publication.--Section 403(c) of the Controlled
Substances Act (21 U.S.C. 843(c)) is amended by--
(1) designating the text as paragraph (1); and
(2) adding at the end the following:
``(2)(A) It shall be unlawful for any person to use the
Internet, or cause the Internet to be used, to advertise the
sale of, or to offer to sell, distribute, or dispense, a
controlled substance except as authorized by this title.
``(B) Violations of this paragraph include causing the
placement on the Internet of an advertisement that refers to
or directs prospective buyers to Internet sellers of
controlled substances who are not registered under section
303(i).
``(C) This paragraph does not apply to material that
either--
[[Page S3716]]
``(i) advertises the distribution of controlled substances
by nonpractitioners to the extent authorized by their
registration under this title; or
``(ii) merely advocates the use of a controlled substance
or includes pricing information without attempting to
facilitate an actual transaction involving a controlled
substance.''.
(i) Injunctive Relief.--Section 512 of the Controlled
Substances Act (21 U.S.C. 882) is amended by adding to the
end of the section the following new subsection:
``(c) State Cause of Action Pertaining to Online
Pharmacies.--(1) In any case in which the State has reason to
believe that an interest of the residents of that State has
been or is being threatened or adversely affected by the
action of a person, entity, or Internet site that violates
the provisions of section 303(i), 309(e), or 311, the State
may bring a civil action on behalf of such residents in a
district court of the United States with appropriate
jurisdiction--
``(A) to enjoin the conduct which violates this section;
``(B) to enforce compliance with this section;
``(C) to obtain damages, restitution, or other
compensation, including civil penalties under section 402(b);
and
``(D) to obtain such other legal or equitable relief as the
court may find appropriate.
``(2)(A) Prior to filing a complaint under paragraph (1),
the State shall serve a copy of the complaint upon the
Attorney General and upon the United States Attorney for the
judicial district in which the complaint is to be filed. In
any case where such prior service is not feasible, the State
shall serve the complaint on the Attorney General and the
appropriate United States Attorney on the same day that the
State's complaint is filed in Federal district court of the
United States. Such proceedings shall be independent of, and
not in lieu of, criminal prosecutions or any other
proceedings under this title or any other laws of the United
States.
``(B)(i) Not later than 120 days after the later of the
date on which a State's complaint is served on the Attorney
General and the appropriate United States Attorney, or the
date on which the complaint is filed, the United States shall
have the right to intervene as a party in any action filed by
a State under paragraph (1).
``(ii) After the 120-day period described in clause (i) has
elapsed, the United States may, for good cause shown,
intervene as a party in an action filed by a State under
paragraph (1).
``(iii) Notice and an opportunity to be heard with respect
to intervention shall be afforded the State that filed the
original complaint in any action in which the United States
files a complaint in intervention under clause (i) or a
motion to intervene under clause (ii).
``(iv) The United States may file a petition for appeal of
a judicial determination in any action filed by a State under
this section.
``(C) Service of a State's complaint on the United States
as required in this paragraph shall be made in accord with
the requirements of Federal Rule of Civil Procedure 4(i)(1).
``(3) For purposes of bringing any civil action under
paragraph (1), nothing in this Act shall prevent an attorney
general of a State from exercising the powers conferred on
the attorney general of a State by the laws of such State to
conduct investigations or to administer oaths or affirmations
or to compel the attendance of witnesses of or the production
of documentary or other evidence.
``(4) Any civil action brought under paragraph (1) in a
district court of the United States may be brought in the
district in which the defendant is found, is an inhabitant,
or transacts business or wherever venue is proper under
section 1391 of title 28, United States Code. Process in such
action may be served in any district in which the defendant
is an inhabitant or in which the defendant may be found.
``(5) No private right of action is created under this
subsection.''.
(j) Forfeiture of Facilitating Property in Drug Cases.--
Section 511(a)(4) of the Controlled Substances Act (21 U.S.C.
881(a)(4)) is amended to read as follows:
``(4) Any property, real or personal, tangible or
intangible, used or intended to be used to commit, or to
facilitate the commission, of a violation of this title or
title III, and any property traceable thereto.''.
(k) Import and Export Act.--Section 1010(b) of the
Controlled Substances Import and Export Act (21 U.S.C.
960(b)) is amended--
(1) in paragraph (4) by--
(A) striking ``or any quantity of a controlled substance in
schedule III, IV, or V, (except a violation involving
flunitrazepam and except a violation involving gamma
hydroxybutyric acid)'';
(B) inserting ``, or'' before ``less than one kilogram of
hashish oil''; and
(C) striking ``imprisoned'' and all that follows through
the end of the paragraph and inserting ``sentenced in
accordance with section 401(b)(1)(D) of this title (21 U.S.C.
841(b)(1)(E)).'';
(2) by adding at the end the following:
``(5) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule III,
such person shall be sentenced in accordance with section
401(b)(1)(E).
``(6) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule IV
(except a violation involving flunitrazepam), such person
shall be sentenced in accordance with section 401(b)(2).
``(7) In the case of a violation of subsection (a) of this
section involving a controlled substance in schedule V, such
person shall be sentenced in accordance with section
401(b)(3).''; and
(3) in paragraph (3), by striking ``, nor shall a person so
sentenced be eligible for parole during the term of such a
sentence'' in the final sentence.
(l) Effective Date.--The amendments made by this Act shall
become effective 60 days after the date of enactment of this
Act.
(m) Guidelines and Regulations.--
(1) In general.--The Attorney General may promulgate and
enforce any rules, regulations, and procedures which may be
necessary and appropriate for the efficient execution of
functions under this subtitle, including any interim rules
necessary for the immediate implementation of this Act, on
its effective date.
(2) Sentencing guidelines.--The United States Sentencing
Commission, in determining whether to amend, or establish
new, guidelines or policy statements, to conform the
guidelines and policy statements to this Act and the
amendments made by this Act, may not construe any change in
the maximum penalty for a violation involving a controlled
substance in a particular schedule as requiring an amendment
to, or establishing a new, guideline or policy statement.
Mr. SESSIONS. Mr. President, after working together with Senator
Feinstein, I am pleased to help introduce the Online Pharmacy Consumer
Protection Act of 2007. I have worked to take the lead in protecting
consumers specifically as it relates to the sale and distribution of
controlled substances over the internet and holding liable those who do
so via unregistered online pharmacies. I commend Senator Feinstein for
her leadership on this issue and look forward to working with her to
pass this important piece of legislation.
This bill would prohibit the distribution of controlled substances by
means of the Internet without a valid prescription and provides for the
legitimate online distribution of those drugs in certain circumstances.
This past January, Attorney General Gonzalez testified to the Judiciary
Committee that abuse of controlled substances is being fed by ``the
proliferation of illicit Web sites that offer controlled substances for
sale, requiring little more than a cursory online questionnaire and
charging double the normal price.'' Gonzales further testified that
``[w]e must preserve legitimate access to medications over the Internet
while preventing online drug dealers from using cyberspace as a haven
for drug trafficking. I look forward to working with the Congress to
ensure that controlled substances are dispensed over the Internet only
for legitimate medical purposes.'' The sale and distribution of
controlled pharmaceuticals on the Internet of great concern because is
gives those who abuse drugs the ability to circumvent the law, and
sound medical practice. This bill would go a long way in addressing the
concerns expressed by Attorney General Gonzalez by reigning in a
practice that has gone unregulated for far too long.
Recently, there has been an explosion in the number of online
pharmacies that provide controlled substances to users without valid
prescriptions. Most illegal drug abuse involving prescription drugs is
associated with Internet purchases, where users are given a
prescription without ever seeing a doctor. The most prominent abuse
occurs with regard to controlled substances such as Hydrocodone,
Valium, Xanax, OxyContin, and Vicodin.
A 2006 study reported that ``a staggering 89 percent of sites selling
controlled prescription drugs have no prescription requirements.''
According to the study, 15.1 million adults admitted to abusing
prescription drugs, including 2.3 million abusers between the ages of
12 and 17. Currently, there is no way to police this illegal activity.
The ease with which consumers may purchase controlled substances from
online pharmacies without a prescription is shocking. Often consumers
can obtain a prescription from physicians employed by the online
pharmacy by simply filling out a brief questionnaire on the pharmacy's
website. Most online pharmacies have no way to verify that the consumer
ordering the prescription is actually who they claim to be, or that the
medical condition the consumer describes actually exists. Thus, drug
addicts and minor children can easily order controlled substances and
prescription drugs over the internet simply by providing false
identities or
[[Page S3716]]
describing non-existent medical conditions.
In 2001, Ryan Haight, a California high school honors student and
athlete, died from an overdose of the painkiller hydrocodone that he
purchased from an online pharmacy. The doctor prescribing hydrocodone
had never met or personally examined Ryan. Ryan simply filled out the
pharmacy's online questionnaire, and described himself as a 25-year-old
male suffering from chronic back pain. Ryan's death could have been
avoided. I believe that Congress is in the best position to help
prevent teenagers from purchasing controlled substances and
prescription drugs from online rouge pharmacies.
I also believe that Congress has the ability to help prevent adult
prescription drug abuse by making it harder to purchase these drugs
online without a valid prescription. The Online Pharmacy Consumer
Protection Act would: (1) provide criminal penalties for those who
knowingly or intentionally (unlawfully) dispense controlled substances
over the Internet, (2) give state attorneys general a civil cause of
action against anyone who violates the Act if they have reason to
believe that the violation affects the interests of their state's
residents, and (3) allow the Federal Government to take possession of
any tangible or intangible property used illegally by online
pharmacies.
The Online Pharmacy Consumer Protection Act would also require online
pharmacies to: (1) file a registration statement with the Attorney
General and meet additional registration requirements promulgated by
him/her, (2) report to the Attorney General any controlled substances
dispensed over the Internet, and (3) comply with licensing and
disclosure requirements.
The Online Pharmacy Consumer Protection Act of 2007 takes a
substantial step towards plugging a loophole in our drug laws by
regulating the practice of distributing controlled substances via the
internet.
By holding unregistered online pharmacies accountable for their
activity, we are ensuring that those who seek to purchase prescription
drugs by using the internet are protected from those engaged in
reprehensible business practices.
Once again I thank Senator Feinstein for her leadership in addressing
this serious issue. I commend this bill to my colleagues for study and
I urge them to support this important legislation.
______
By Mrs. CLINTON (for herself, Ms. Collins, Mr. Bingaman, and Ms.
Mikulski):
S. 982. A bill to amend the Public Health Service Act to provide for
integration of mental health services and mental health treatment
outreach teams, and for other purposes; to the Committee on Health,
Education, Labor, and Pensions.
Mrs. CLINTON. Mr. President, today, Senator Collins and I are
reintroducing the Positive Aging Act, to improve the accessibility and
quality of mental health services for our rapidly growing population of
older Americans. I want to thank Senator Collins for her leadership on
aging issues, and for partnering with me on numerous pieces of
legislation and initiatives related to these and other important health
issues.
We are pleased to be reintroducing this important legislation in
anticipation of reauthorization of the Substance Abuse and Mental
Health Services Administration (SAMHSA).
I want to acknowledge and thank our partners from the mental health
and aging community who have collaborated with us and have been working
diligently on these issues for many years, including the American
Psychological Association, the American Association for Geriatric
Psychiatry, the National Association of Social Workers, the Alzheimer's
Association, the New York City Chapter of the Alzheimer's Association,
the American Association of Homes and Services for the Aging, the
American Academy of Child and Adolescent Psychiatry, the American
Mental Health Counselors Association, the American Society on Aging,
the Depression and Bipolar Support Alliance, the Geriatric Mental
Health Alliance of New York, the Gerontological Society of America,
Mental Health America, the National Association of State Mental Health
Program Directors, the National Council on Aging, Psychologists in Long
Term Care, the Older Women's League, the Society of Clinical
Geropsychology, the Suicide Prevention Action Network USA, and all the
other groups who have lent their support.
American society today has benefited tremendously from advances in
medical science that are helping us to live longer than ever before. In
New York State alone, there are an estimated two and a half million
citizens aged 65 or older. And this population will only continue to
grow as the first wave of Baby Boomers turns 65 in less than ten years.
According to a December 2006 report from the U.S. Census Bureau, the
number of older Americans aged 65 and over is expected to double over
the next 25 years, and nearly 20 percent of citizens will be 65 years
or older by the year 2030. Further, the fastest growing segment of the
U.S. population is the age group of Americans who are 85 and older.
Although it is encouraging that our Nation's citizens are living
longer than ever before, mental and behavioral health challenges
accompany this increased longevity. So as we look forward to leading
longer lives, we must also acknowledge the challenges that we face
related to the quality of life as we age.
Although most older adults enjoy good mental health, it is estimated
that nearly 20 percent of Americans age 55 or older experience a mental
disorder. In New York State alone, there are an estimated 366,000
adults aged 55 or older with mental health or substance abuse
disorders. Nationally, it is anticipated that the number of seniors
with mental and behavioral health problems will almost quadruple, from
4 million in 1970 to 15 million in 2030.
Among the most prevalent mental health concerns older adults
encounter are anxiety, depression, cognitive impairment, and substance
abuse. When left untreated, these problems can have severe physical and
psychological implications. In fact, men age 85 and older have the
highest rates of suicide in our country and depression is the foremost
risk factor.
The physical consequences of mental health disorders can be both
expensive and debilitating. Depression has a powerful negative impact
on ability to function, resulting in high rates of disability. The
World Health Organization projects that by the year 2020, depression
will remain a leading cause of disability, second only to
cardiovascular disease. Even mild depression lowers immunity and may
compromise a person's ability to fight infections and cancers. Research
indicates that 50-70 percent of all primary care medical visits are
related to psychological factors such as anxiety, depression, and
stress. Further, evidence suggests that an estimated 75 percent of
seniors who commit suicide have visited a primary care professional
within a month of their death.
Mental disorders do not have to be a part of the aging process
because we have effective treatments for these conditions. But despite
these effective treatments, too many American seniors go without the
services they need and deserve because of poor integration of physical
and mental health care. As of 2006, only 37 percent of New Yorkers who
suffer from depression had obtained mental health treatment.
The current divide in our country between health care and mental
health care manifests itself in many ways. Too often physicians and
other health professionals fail to recognize the signs and symptoms of
mental health problems. Even more troubling, knowledge about treatment
is simply not accessible to many primary care practitioners. As a
whole, we have failed to fully integrate mental health screening and
treatment into our health service systems.
These missed opportunities to diagnose and treat mental health
disorders are taking a tremendous toll on seniors and increasing the
burden on their families and our health care system.
It is within our power and our responsibility to bridge the gap
between physical and mental health care and help promote the well-being
of older Americans.
In last year's reauthorization of the Older Americans Act, Senator
Collins and I successfully enacted Title I of the Positive Aging Act of
2005, which authorized grants for the delivery of mental health
screening and treatment
[[Page S3717]]
services for older adults and grants to promote awareness and reduce
stigma regarding mental disorders in later life.
While this took an important step toward improving mental health
services for older adults, significant efforts are necessary to ensure
comprehensive geriatric mental health care.
That is why I am reintroducing the Title II provisions of the
Positive Aging Act of 2005 as the Positive Aging Act of 2007 with my
cosponsor Senator Collins. This legislation would amend the Public
Health Service Act to improve access to mental health services for our
nation's seniors by integrating mental health services into primary
care and community settings.
Specifically, the Positive Aging Act of 2007 would fund demonstration
projects to support integration of mental health services in primary
care settings.
It would fund grants for community-based mental health treatment
outreach teams to improve older Americans' access to mental health
services.
This legislation would also ensure that these geriatric mental health
programs have proper attention and oversight by: mandating the
designation of a Deputy Director for Older Adult Mental Health Services
in the Center for Mental Health Services; including representatives of
older Americans or their families and geriatric mental health
professionals on the Advisory Council for the Center for Mental Health
Services; and requiring state plans under Community Mental Health
Services Block Grants to include descriptions of the states' outreach
to and services for older individuals.
And because substance-related disorders require the same attention as
mental health conditions, the Positive Aging Act of 2007 will target
substance abuse in older adults in projects of national significance.
Today, we are fortunate to have a variety of effective treatments to
address the mental health needs of American seniors. I believe that we
owe it to older adults in this country to do all that we can to ensure
that they have access to high quality mental health care, so they can
enjoy their golden years.
The Positive Aging Act of 2007 takes a critical step in this
direction, and I look forward to working with my colleagues to enact
this legislation during the upcoming SAMHSA reauthorization.
Mr. President, I ask unanimous consent that letters of support be
printed in the Record.
There being no objection, the letters were ordered to be printed in
the Record, as follows:
National Association
of Social Workers,
Washington, DC, March 23, 2007
Senator Hillary Rodham Clinton,
Russell Senate Office Building
Washington, DC.
Senator Susan M. Collins,
Dirkson Senate Office Building,
Washington, DC.
Dear Senators Clinton and Collins: The National Association
of Social Workers (NASW) is the largest professional social
work organization, with 150,000 members nationwide. NASW
promotes, develops, and protects the practice of social work
and social workers, while enhancing the well-being of
individuals, families, and communities through its work,
service, and advocacy.
NASW fully supports the Positive Aging Act of 2007, which
you are introducing today, along with Representatives Patrick
Kennedy (D-MA) and Ileana Ros-Lehtinen (R-FL). Many older
adults are currently unable to obtain much-needed mental
health services for a variety of reasons, including lack of
access and the stigma attached to mental illness. The
Positive Aging Act of 2007 will help integrate primary care
with mental health care for older adults, particularly those
with low incomes, living in community settings.
Social workers are aware of the problems older people
encounter in obtaining necessary mental health care.
Frequently, they are called upon to address older adults'
mental health needs only after crises arise, when the
emotional toll on clients and their families is much higher,
and the costs to Medicare are much more significant.
Clinical social workers assess and treat many older
Americans with mental health needs. In fact, more than 39,000
social workers now participate in Medicare, delivering mental
health services and enabling many thousands of older
beneficiaries to lead more fulfilling and healthier lives.
NASW is particularly supportive of the multidisciplinary
teams of mental health professionals envisioned in this bill
as an integral part of primary care services. These teams,
which include professional social workers, will have the
training and competence to meet older Americans' diverse
physical and behavioral health needs. The Association
commends the senators and representatives for raising these
vital health issues, and urges Congress to move quickly to
enact this legislation.
Thank you for your leadership on this vital health care
issue.
Sincerely,
Carolyn Polowy,
General Counsel.
____
American Psychological Association,
March 23, 2007.
Hon. Hillary Rodham Clinton,
U.S. Senate,
Washington, DC.
Hon. Susan M. Collins,
U.S. Senate,
Washington, DC.
Dear Senators Clinton and Collins: On behalf of the 148,000
members and affiliates of the American Psychological
Association (APA), I am writing to applaud your ongoing
commitment to the mental and behavioral health needs of older
Americans and express our strong support for the Positive
Aging Act of 2007. This important legislation will improve
access to vital mental and behavioral health care for older
adults by supporting the integration of mental health
services into primary care and community settings.
An estimated 20 percent of community-based older adults in
the U.S. have a mental health problem. These disorders can
have a significant impact on both physical and mental health,
often leading to increases in disease, disability, and
mortality. Evidence suggests that up to 75 percent of older
adults who commit suicide have visited a primary care
professional within 30 days of their death. Although
effective treatments exist, the mental health needs of many
older Americans go unrecognized and untreated because of
poorly integrated systems of care to address the physical and
mental health needs of seniors.
The Positive Aging Act of 2007 takes an important step
toward improving access to quality mental and behavioral
health care for older adults by integrating mental health
services into primary care and community settings where older
adults reside and receive services. By supporting
collaboration between interdisciplinary teams of mental
health professionals and other providers of health and social
services, this legislation promotes an integrated approach to
addressing the health and well being of our nation's growing
older adult population.
We commend you for your leadership and commitment to the
mental and behavioral health needs of older adults and look
forward to working with you to ensure enactment of the
Positive Aging Act. If we can be of further assistance,
please feel free to contact Diane Elmore, Ph.D., in our
Government Relations Office at (202) 336-6104 or
[email protected].
Sincerely,
Gwendolyn Puryear Keita,
Executive Director,
Public Interest Directorate.
____
Positive Aging Act of 2007 Organizational Supporters--March 2007
Alzheimer's Association; Alzheimer's Association, New York
City Chapter; American Academy of Child and Adolescent
Psychiatry; American Association for Geriatric Psychiatry;
American Association of Homes and Services for the Aging;
American Association of Pastoral Counselors; American Group
Psychotherapy Association; American Mental Health Counselors
Association; American Occupational Therapy Association;
American Psychological Association; American Psychotherapy
Association; American Society on Aging; Anxiety Disorders
Association of America; Association for Ambulatory Behavioral
Healthcare; Bazelon Center for Mental Health Law; Clinical
Social Work Association; Clinical Social Work Guild 49,
OPEIU; Depression and Bipolar Support Alliance; Geriatric
Mental Health Alliance of New York; Gerontological Society of
America.
Kansas Mental Health and Aging Coalition; Mental Health
America; Mental Health and Aging Coalition of Eastern Kansas;
National Alliance for Caregiving; National Association for
Children's Behavioral Health; National Association of Mental
Health Planning and Advisory Councils; National Association
of Psychiatric Health Systems; National Association of Social
Workers; National Association of State Mental Health Program
Directors; National Council on Aging; Oklahoma Mental Health
and Aging Coalition; Older Adult Consumers Alliance Older
Women's League; Pennsylvania Behavioral Health and Aging
Coalition; Psychologists in Long Term Care; Society of
Clinical Geropsychology; Suicide Prevention Action Network
USA.
____
American Association
for Geriatric Psychiatry,
Bethesda, MD, March 20, 2007.
Hon. Hillary Rodham Clinton,
U.S. Senate,
Washington, DC.
Dear Senator Clinton: The American Association for
Geriatric Psychiatry (AAGP) is
[[Page S3718]]
pleased to endorse the ``Positive Aging Act of 2007.''
The ``Positive Aging Act'' will improve the accessibility
and quality of mental health services for the rapidly growing
population of older Americans. Through projects administered
by the Substance Abuse and Mental Health Services
Administration, this legislation will integrate mental health
services with other primary care services in community
settings that are easily accessible to the elderly.
Dementia, depression, anxiety and substance abuse among
Americans over age 65 are growing problems that result in
functional dependence, longterm institutional care and
reduced quality of life. Missed opportunities to diagnose and
treat mental diseases are taking a tremendous toll on the
elderly and increasing the burden on families and the health
care system. The ``Positive Aging Act'' will increase
opportunities for effective diagnosis and treatment of mental
disorders among the elderly.
AAGP is a professional membership organization dedicated to
promoting the mental health and well-being of older people
and improving the care of those with late-life mental
disorders. AAGP's membership consists of 2,000 geriatric
psychiatrists, as well as other health professionals who
focus on the mental health problems faced by senior citizens.
In addition, AAGP has an active Foundation which focuses on
reducing the stigma of mental disorders in the aging
population.
AAGP appreciates your leadership in addressing the mental
health needs of older Americans, and we look forward to
working with you on this legislation.
Sincerely,
Christine deVries,
Executive Director.
____________________