[Congressional Record Volume 156, Number 133 (Wednesday, September 29, 2010)]
[House]
[Pages H7316-H7318]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SECURE AND RESPONSIBLE DRUG DISPOSAL ACT OF 2010
Mr. INSLEE. Madam Speaker, I move to suspend the rules and pass the
Senate bill (S. 3397) to amend the Controlled Substances Act to provide
for take-back disposal of controlled substances in certain instances,
and for other purposes, as amended.
The Clerk read the title of the bill.
The text of the amendment is as follows:
Amendment:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Secure and Responsible Drug
Disposal Act of 2010''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) The nonmedical use of prescription drugs is a growing
problem in the United States, particularly among teenagers.
(2) According to the Department of Justice's 2009 National
Prescription Drug Threat Assessment--
(A) the number of deaths and treatment admissions for
controlled prescription drugs (CPDs) has increased
significantly in recent years;
(B) unintentional overdose deaths involving prescription
opioids, for example, increased 114 percent from 2001 to
2005, and the number of treatment admissions for prescription
opioids increased 74 percent from 2002 to 2006; and
(C) violent crime and property crime associated with abuse
and diversion of CPDs has increased in all regions of the
United States over the past 5 years.
(3) According to the Office of National Drug Control
Policy's 2008 Report ``Prescription for Danger'',
prescription drug abuse is especially on the rise for teens--
(A) one-third of all new abusers of prescription drugs in
2006 were 12- to 17-year-olds;
(B) teens abuse prescription drugs more than any illicit
drug except marijuana--more than cocaine, heroin, and
methamphetamine combined; and
(C) responsible adults are in a unique position to reduce
teen access to prescription drugs because the drugs often are
found in the home.
(4)(A) Many State and local law enforcement agencies have
established drug disposal programs (often called ``take-
back'' programs) to facilitate the collection and destruction
of unused, unwanted, or expired medications. These programs
help get outdated or unused medications off household shelves
and out of the reach of children and teenagers.
(B) However, take-back programs often cannot dispose of the
most dangerous pharmaceutical drugs--controlled substance
medications--because Federal law does not permit take-back
programs to accept controlled substances unless they get
specific permission from the Drug Enforcement Administration
and arrange for full-time law enforcement officers to receive
the controlled substances directly from the member of the
public who seeks to dispose of them.
(C) Individuals seeking to reduce the amount of unwanted
controlled substances in their household consequently have
few disposal options beyond discarding or flushing the
substances, which may not be appropriate means of disposing
of the substances. Drug take-back programs are also a
convenient and effective means for individuals in various
communities to reduce the introduction of some potentially
harmful substances into the environment, particularly into
water.
(D) Long-term care facilities face a distinct set of
obstacles to the safe disposal of controlled substances due
to the increased volume of controlled substances they handle.
(5) This Act gives the Attorney General authority to
promulgate new regulations, within the framework of the
Controlled Substances Act, that will allow patients to
deliver unused pharmaceutical controlled substances to
appropriate entities for disposal in a safe and effective
manner consistent with effective controls against diversion.
(6) The goal of this Act is to encourage the Attorney
General to set controlled substance diversion prevention
parameters that will allow public and private entities to
develop a variety of methods of collection and disposal of
controlled substances, including some pharmaceuticals, in a
secure, convenient, and responsible manner. This will also
serve to reduce instances of diversion and introduction of
some potentially harmful substances into the environment.
SEC. 3. DELIVERY OF CONTROLLED SUBSTANCES BY ULTIMATE USERS
FOR DISPOSAL.
(a) Regulatory Authority.--Section 302 of the Controlled
Substances Act (21 U.S.C. 822) is amended by adding at the
end the following:
``(g)(1) An ultimate user who has lawfully obtained a
controlled substance in accordance with this title may,
without being registered, deliver the controlled substance to
another person for the purpose of disposal of the controlled
substance if--
``(A) the person receiving the controlled substance is
authorized under this title to engage in such activity; and
``(B) the disposal takes place in accordance with
regulations issued by the Attorney General to prevent
diversion of controlled substances.
``(2) In developing regulations under this subsection, the
Attorney General shall take into consideration the public
health and safety, as well as the ease and cost of program
implementation and participation by various communities. Such
regulations may not require any entity to establish or
operate a delivery or disposal program.
``(3) The Attorney General may, by regulation, authorize
long-term care facilities, as defined by the Attorney General
by regulation, to dispose of controlled substances on behalf
of ultimate users who reside, or have resided, at such long-
term care facilities in a manner that the Attorney General
determines will provide effective controls against diversion
and be consistent with the public health and safety.
``(4) If a person dies while lawfully in possession of a
controlled substance for personal use, any person lawfully
entitled to dispose of the decedent's property may deliver
the controlled substance to another person for the purpose of
disposal under the same conditions as provided in paragraph
(1) for an ultimate user.''.
(b) Conforming Amendment.--Section 308(b) of the Controlled
Substances Act (21 U.S.C. 828(b)) is amended--
(1) by striking the period at the end of paragraph (2) and
inserting ``; or''; and
(2) by adding at the end the following:
``(3) the delivery of such a substance for the purpose of
disposal by an ultimate user, long-term care facility, or
other person acting in accordance with section 302(g).''.
SEC. 4. DIRECTIVE TO THE UNITED STATES SENTENCING COMMISSION.
Pursuant to its authority under section 994 of title 28,
United States Code, the United States Sentencing Commission
shall review and, if appropriate, amend the Federal
sentencing guidelines and policy statements to ensure that
the guidelines and policy statements provide an appropriate
penalty increase of up to 2 offense levels above the sentence
otherwise applicable in Part D of the Guidelines Manual if a
person is convicted of a drug offense resulting from the
authorization of that person to receive scheduled substances
from an ultimate user or long-term care facility as set forth
in the amendments made by section 3.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Washington (Mr. Inslee) and the gentleman from Pennsylvania (Mr. Pitts)
each will control 20 minutes.
The Chair recognizes the gentleman from Washington.
General Leave
Mr. INSLEE. Madam Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and include extraneous material in the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Washington?
There was no objection.
Mr. INSLEE. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise today in strong support of S. 3397, as amended,
the Secure and Responsible Drug Disposal Act of 2010. This bill is our
effort to respond to the very rapidly rising rate of prescription drug
abuse in our country where 2,500 teens a day are using prescription
drugs illegally for the first time. And this bill will help, we think,
significantly in helping remove prescription drugs from the illicit
drug pipeline by giving citizens an ability to get rid of their drugs,
their prescription drugs, in a legal fashion so that communities can
fashion a way to create drug take-back programs so citizens can get rid
of their unnecessary and no longer useful prescription drugs.
The House has previously passed a version. We have made some
improvements to the bill after it went through the Senate. I just want
to note some of those improvements.
Today, when people do not have ready access to drug disposal
programs, they often flush them down, and drugs ultimately end up in
the waterways. In order to ensure that the drug take-back programs that
we fashion under this bill are environmentally sound, it's important
that the Attorney General consider the environmental impacts of take-
back programs and work with the Environmental Protection Agency and
communities on appropriate ways to dispose of the collected
[[Page H7317]]
substance in an environmentally sound manner. We also have provided
ways to make sure communities are engaged in designing these programs
so that they meet the individual needs of specific communities.
I want to thank all the people who have worked on this bipartisan
legislation, particularly Representative Stupak who is ending his
congressional career having done some great work in this regard.
With that, I yield as much time as he may consume to the gentleman
from Michigan (Mr. Stupak).
Mr. STUPAK. I thank the gentleman for yielding, and I rise in support
of S. 3397.
Millions of Americans are prescribed narcotics for postoperative
pain, bone fractures, and other ailments each year. However, most
patients do not consume all the prescriptions they are prescribed.
These drugs remain in drug cabinets for years, easily accessible to
teens wishing to experiment with drugs.
But failure to dispose of prescription medications properly causes
several problems. First, there's the potential for a child to ingest
the drugs accidently. Second, we know that teen prescription drug abuse
is on the rise. Unused prescriptions in a house are easily accessible
to teens wishing to experiment with drugs. Third, there's a potential
for narcotics to be abused by the patient or sold to someone else to
abuse.
{time} 2010
The Controlled Substance Act regulates prescription narcotics through
a registration system. Currently there are roughly 1.3 million DEA
registrants who are legally allowed to handle or distribute narcotics
from the manufacturer to the distributor to the pharmacist to the
doctor. However, the Controlled Substance Act currently exempts
patients from this registration requirement. This legislation allows
individuals to dispose of unused prescription controlled substances to
a recipient authorized by the DEA, Drug Enforcement Administration.
The bill also authorizes the Attorney General to promulgate
regulations for the lawful disposal of prescription controlled
substances by a long-term care facility. S. 3397 also clarifies that
the DEA regulations set forth in this legislation may not require any
entity to establish a drug take-back program. It's a voluntary program.
I want to thank my friend and colleague Jay Inslee for all of his
hard work on this legislation and his staff over the past years, Lamar
Smith on the minority side, who worked closely with us, and colleagues
on both sides of the aisle and their staff for their hard work and
commitment to empower patients to prevent prescription drug abuse,
especially amongst young people.
I urge my colleagues to vote in support of this legislation.
Mr. PITTS. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, the Secure and Responsible Drug Disposal Act will
improve drug take-back programs where pharmacies and others accept
unused prescription drugs and dispose of them safely. Prescription
drugs provide valuable therapeutic benefits to tens of millions of
Americans, from treating disease to improving people's quality of life.
However, a segment of our society does not use these medications for
therapy but, rather, abuses them for some sort of dangerous high. Many
teenagers get their hands on these medications by stealing unused
medications from the family's medicine cabinet.
While some pharmacies, States, and localities have established
prescription drug take-back programs, these programs may not take back
controlled substances due a technical reading of the Controlled
Substances Act. By passing this legislation, these programs could help
further reduce the likelihood of prescription drugs being diverted to
those to whom they were not prescribed.
It is important to note that this bill does not require any entity to
establish a drug take-back program. But if a drug take-back program
currently operates, it only makes sense to allow that facility to take
back controlled drugs like oxycontin as well as noncontrolled
prescription drugs.
I urge my colleagues to support this bill.
I reserve the balance of my time.
Mr. INSLEE. I reserve the balance of my time.
Mr. PITTS. I yield such time as he may consume to the gentleman from
Indiana (Mr. Buyer).
Mr. BUYER. I thank the gentleman for yielding, and I want to
compliment the authors of the legislation in your work on this.
But I would like to point out something before we get too excited
about whether we are doing a good thing today. Number one, we are--but
what are we leaving on the table? If we are trying to address the issue
with regard to prescription drugs and making sure that that drug gets
in the hands of the right person and that the drug is safe, there is a
bigger issue out there. It is called the drug safety issue and whether
America's closed system is truly closed. And what we are leaving on the
table is an issue which this Congress has not addressed, and it's John
Dingell's drug safety bill. And not only is it that, its electronic
pedigree, red paper pedigree with regard to drug safety, but the
biggest one of all, I would say to the Colombian drug cartel, is that
you're in the wrong drug business. We have got all the laws imaginable
to whack you pretty hard for your cocaine and your marijuana. But the
great threat that is occurring right now to America are drugs coming
into the country that we know are not safe.
Now, let's do a quick little math because I am leaving Congress, and
this is an issue that those of you who are still here, we, as a Nation,
you, as legislators, must address this. We have 11 international mail
facilities, 11 of them. Our ports of entry. You add UPS at Louisville
and FedEx at Memphis, 13. Every day we have on average of 35,000
pharmaceutical packages coming into the international mail facilities.
They are coming in because people are getting them on the Internet, and
they are going to some drugsave.com out of Canada or whomever. They
think it is safe, and they think that that drug is just like what I can
get down at my local drugstore, and they order it. And it's coming
through illicit, bad operators who are preying on America's sick and
elderly.
Every time FDA goes out there and checks, we are finding that, on
average, 80 percent of those drugs are either adulterated, knock-off,
or they are counterfeit. Now let's do the math: 13 international mail
facilities times 35,000 average per day, that gives you 455,000 of
these pharmaceutical packages per day, times 365. Now we are in excess
of 160 million pharmaceutical packages. We are talking boxes of drugs,
not just little ones. We are talking boxes of drugs. And if 80 percent
of that number are counterfeit, knock-off, adulterated drugs, we are in
excess of 132 million.
Now, of a smaller percentage that the FDA actually finds and
discovers, we have a return-to-sender policy. That's why I wanted to
address this. Can you believe that? FDA has a return-to-sender policy.
So here we are--I compliment you. We are going to say, Okay, if these
drugs aren't good, we want to make sure they don't get into the hands
of the people that the doctor doesn't want them to. So we are going to
say, Let's destroy them. But as a Nation, our FDA has a return-to-
sender policy. So when they discover in an international mail facility
that the package is adulterated, knock-off, or counterfeit drugs, they
don't destroy them. They do not destroy them. They then take that
package and send it back to the bad actor. The bad actor must think,
America, what a great place. What a great place. I will steal people's
money; I will prey on the sick and the elderly; and the American
Government will actually send my counterfeit drugs back to me so I can
do it again.
So I just want to make this point. Your legislation is absolutely
wonderful. But I want to point out, there is a really large problem out
there. So before we get too excited that we are doing something really
good--and we are but on a much smaller level. Because if we are going
to allow millions of people to gain access to these types of drugs, we
know that these drugs do not metastasize in the body in the way in
which the doctors are intending them to do. And people actually think
that the drugs they are taking are exactly what they can get down at
CVS
[[Page H7318]]
or Walgreens or whatever, and it's not happening.
So my only point I appeal to all of you is, number one,
congratulations; number two, we have a really large issue that we need
to address in the next Congress. We really do. And let's get our arms
around this. I want to congratulate John Dingell on his drug safety
bill. And it's a shame that we actually weren't able to get this done
in the committee. Again, my compliments to you. But this is a big issue
as a Nation we must address and protect America.
Mr. INSLEE. I just want to thank Senators Klobuchar and Cornyn for
their work on this and say this is a good bipartisan effort. We are not
done on this, as Mr. Buyer pointed out, but this is a good start. I
urge passage.
Mr. INSLEE. I yield back the balance of my time.
Mr. PITTS. I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Jackson of Illinois). The question is on
the motion offered by the gentleman from Washington (Mr. Inslee) that
the House suspend the rules and pass the bill, S. 3397, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.