[Congressional Record Volume 145, Number 58 (Tuesday, April 27, 1999)]
[Senate]
[Pages S4275-S4277]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
By Mr. BIDEN:
S. 885. A bill to amend the Public Health Service Act and the Federal
Food, Drug, and Cosmetic Act to provide incentives for the development
of drugs for the treatment of addiction to illegal drugs, and for other
purposes; to the Committee on Health, Education, Labor, and Pensions.
the new medicines to treat addiction act of 1999
Mr. BIDEN. Mr. President, today I am introducing the New Medicines to
Treat Addiction Act of 1999, legislation that builds upon my efforts in
previous Congresses to promote research into and development of new
medicines to treat the ravages of hard core drug addiction.
Since the first call to arms against illegal drugs, we have learned
just how insidious hard-core drug addiction is, even as the ravages of
substance abuse--on both the addict and the addict's victims--have
become ever more apparent. The frustration in dealing with a seemingly
intractable national problem is palpable, most noticeably in the heated
rhetoric as politicians blame each other for the failure to find a
cure. What gets lost underneath the noise is the recognition that we
have not done everything we can to fight this problem and that, like
all serious ills, we must take incremental steps one at a time, and
refuse to be overwhelmed by the big picture.
Throughout my tenure as chairman of the Senate Judiciary Committee, I
called for a multifaceted strategy to combat drug abuse. One of the
specific steps I advocated was the creation of incentives to encourage
the private sector to develop medicines that treat addiction, an area
where promising research has not led--as one would normally expect--to
production of medicines. The bill I am introducing today, the New
Medicines To Treat Addiction Act of 1999, will hopefully change that.
It takes focused aim at one segment of the drug-abusing population--
hardcore addicts, namely users of cocaine and heroin--in part because
these addicts are so difficult to treat with traditional methods, and
in part because this population commits such a large percentage of
drug-related crime.
In December, 1989, I commissioned a Judiciary Committee report,
``Pharmacotherapy: A Strategy for the 1990's.'' In that report, I posed
the question, ``If drug use is an epidemic, are we doing enough to find
a medical `cure' for this disease?'' The report gave the answer ``No.''
Unfortunately, now a decade later, the answer remains the same.
Developing new medicines for the treatment of addiction should be among
our highest medical research priorities as a nation. Until we take this
modest step, we cannot claim to have done everything reasonable to
address the problem, and we should not become so frustrated that we
effectively throw up our hands and do nothing.
Recent medical advances have increased the possibility of developing
medications to treat drug addiction. These advances include a
heightened understanding of the physiologist and psychological
characteristics of drug addiction and a greater base of neuroscientific
research.
One example of this promising research is the recent development of a
compound that has been proven to immunize laboratory animals against
the effects of cocaine. The compound works like a vaccine by
stimulating the immune system to develop an antibody that blocks
cocaine from entering the brain. Researchers funded through the
National Institute of Drug Abuse believe that this advance may open a
whole new avenue for combating addiction.
Despite this progress, we still do not have a medication to treat
cocaine addiction or drugs to treat many other forms of substance
abuse, because the private sector is unsure of the wisdom of making the
necessary investment in the production and marketing of such medicines.
Privarte industry has not aggressively developed pharmacotherapies
for a variety of reasons, including a small customer base, difficulties
distributing medication to the target population, and fear of being
associated with substance abusers. We need to create financial
incentives to encourage pharmaceutical companies to develop and market
these treatments. And we need to develop a new partnership between
private industry and the public sector in order to encourage the active
marketing and distribution of new medicines so they are accessible to
all addicts in need of treatment.
While pharmacotherapies alone are not a ``magic bullet'' that will
solve our national substance abuse problem, they have the potential to
fill a gap in current treatment regimens. The disease of addiction
occurs for many reasons, including a variety of personal problems which
pharmaco therapy cannot address. Still, by providing a treatment
regimen for drug abusers who are not helped by traditional methods,
pharmacotherapy holds substantial promise for reducing the crime and
health crisis that drug abuse is causing in the United States.
The New Medicines To Treat Addiction Act of 1999 would encourage and
support the development of medicines to treat drug addiction in three
ways.
It reauthorizes and increases funding for Medications Development
Program at the National Institute of Health, which for years has been
at the forefront of research into drug addition.
The bill also creates two new incentives for private sector companies
to undertake the difficult but important task of developing medicines
to treat addiction.
First, the bill would provide additional patient protections for
companies that develop drugs to treat substance abuse. Under the bill,
pharmacotherapies could be designated `orphan drugs' and qualify for an
exclusive seven-year patent to treat specific addiction. These
extraordinary patent rights would greatly enhance the market value of
pharmacotherapies and provide a financial reward for companies that
invest in the search to cure drug addiction. This provision was
contained in a bill introduced by Senator Kennedy and me in 1990, but
was never acted on by Congress.
Second, the bill would establish a substantial monetary reward for
companies that develop drugs to treat cocaine and heroin addiction but
shift the responsibility for marketing and distributing such drugs to
the government. This approach would create a financial incentive for
drug companies to invest in research and development but enable them to
avoid any stigma associated with distributing medicine to substance
abusers.
The bill would require the National Academy of Sciences to develop
strict guidelines for evaluating whether a drug effectively treats
cocaine or heroin addiction. If a drug meets these guidelines and is
approved by the Food and Drug Administration, then the government must
purchase the patent rights for the drug from the company that developed
it. The purchase rights for the patent rights is established by
[[Page S4276]]
law: $100 million for a drug to treat cocaine addiction and $50 million
for a drug to treat heroin addiction. Once the government has purchased
the patent rights, then it is responsible for producing the drug and
distributing it to clinics, hospitals, state and local governments, and
any other entities qualified to operate drug treatment programs.
This joint public/private endeavor will correct the market
inefficiencies that have thus far prevented the development of drugs to
treat addiction and require the government to take on the
responsibilities that industry is unwilling or unable to perform.
America's drug problems is reduced each and every time a drug abuser
quits his or her habit. Fewer drug addicts mean fewer crimes, fewer
hospital admissions, fewer drug-addicted babies and fewer neglected
children. The benefits to our country of developing new treatment
options such as pharmacotherapies are manifold. Each dollar we spend on
advancing options in this area can save us ten or twenty times as much
in years to come. The question isn't ``Can we afford to pursue a
pharmacotherapy strategy?'' but rather, ``Can we afford not to?''
Congress has long neglected to adopt measures I have proposed to
speed the approval of and encourage greater private sector interest in
pharmaco therapy. We cannot let another Congress conclude without
rectifying our past negligence on this issue. I urge my colleagues to
join me in promoting an important, and potentially ground breaking,
approach to addressing one of our Nation's most serious domestic
challenges.
Mr. President, I ask unanimous consent that the text of the bill be
printed in the Record.
There being no objection, the bill was ordered printed in the Record,
as follows:
S. 885
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 ``New Medications to Treat
Addiction Act of 1999''.
TITLE I--PHARMACOTHERAPY RESEARCH
SEC. 101. REAUTHORIZATION FOR MEDICATION DEVELOPMENT PROGRAM.
Section 464P(e) of the Public Health Service Act (42 U.S.C.
285o-4(e)) is amended to read as follows:
``(e) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 2000 through 2002
of which the following amount may be appropriated from the
Violent Crime Reduction Trust Fund:
``(1) $100,000,000 for fiscal year 2001; and
``(2) $100,000,000 for fiscal year 2002.''.
TITLE II--PATENT PROTECTIONS FOR PHARMACOTHERAPIES
SEC. 201. RECOMMENDATION FOR INVESTIGATION OF DRUGS.
Section 525(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360aa(a)) is amended--
(1) in the first sentence, by striking ``States'' and
inserting ``States, or for treatment of an addiction to
illegal drugs,'';
(2) in the second sentence, by striking ``States'' and
inserting ``States, or for treatment of an addiction to
illegal drugs''; and
(3) by striking ``such disease or condition'' each place it
appears and inserting ``such disease or condition, or
treatment of such addiction,''.
SEC. 202. DESIGNATION OF DRUGS.
Section 526(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bb(a)) is amended--
(1) in paragraph (1)--
(A) by inserting before the period in the first sentence
the following: ``, or for treatment of an addiction to
illegal drugs'';
(B) in the third sentence, by striking ``rare disease or
condition'' and inserting ``rare disease or condition, or for
treatment of an addiction to illegal drugs,'';
(C) by striking ``such disease or condition,'' and
inserting ``such disease or condition, or treatment of such
addiction,''; and
(D) by striking ``such disease or condition.'' and
inserting ``such disease or condition, or treatment of such
addiction.''; and
(2) in paragraph (2)--
(A) by striking ``(2) For'' and inserting ``(2)(A) For'';
(B) by striking ``(A) affects'' and inserting ``(i)
affects'';
(C) by striking ``(B) affects'' and inserting ``(ii)
affects''; and
(D) by adding at the end the following:
``(B) For purposes of this subchapter, the term `treatment
of an addiction to illegal drugs' means treatment by any
pharmacological agent or medication that--
``(i) reduces the craving for an illegal drug for an
individual who--
``(I) habitually uses the illegal drug in a manner that
endangers the public health, safety, or welfare; or
``(II) is so addicted to the use of the illegal drug that
the individual is not able to control the addiction through
the exercise of self-control;
``(ii) blocks the behavioral and physiological effects of
an illegal drug for an individual described in clause (i);
``(iii) safely serves as a replacement therapy for the
treatment of abuse of an illegal drug for an individual
described in clause (i);
``(iv) moderates or eliminates the process of withdrawal
from an illegal drug for an individual described in clause
(i);
``(v) blocks or reverses the toxic effect of an illegal
drug on an individual described in clause (i); or
``(vi) prevents, where possible, the initiation of abuse of
an illegal drug in individuals at high risk.
``(C) The term `illegal drug' means a controlled substance
identified under schedules I, II, III, IV, and V in section
202(c) of the Controlled Substances Act (21 U.S.C.
812(c)).''.
SEC. 203. PROTECTION FOR DRUGS.
Section 527 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360cc) is amended--
(1) in subsection (a), by striking ``rare disease or
condition,'' and inserting ``rare disease or condition, or
for treatment of an addiction to illegal drugs,'';
(2) in subsection (b), by striking ``rare disease or
condition'' and inserting ``rare disease or condition, or for
treatment of an addiction to illegal drugs,'';
(3) by striking ``such disease or condition'' each place it
appears and inserting ``such disease or condition, or
treatment of such addiction,''; and
(4) in subsection (b)(1), by striking ``the disease or
condition'' and inserting ``the disease, condition, or
addiction''.
SEC. 204. OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS.
Section 528 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360dd) is amended--
(1) by striking ``rare disease or condition'' and inserting
``rare disease or condition, or for treatment of an addiction
to illegal drugs,''; and
(2) by striking ``the disease or condition'' each place it
appears and inserting ``the disease, condition, or
addiction''.
SEC. 205. CONFORMING AMENDMENTS.
(a) Subchapter Heading.--The subchapter heading of
subchapter B of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360aa et seq.) is amended by striking
``Conditions'' and inserting ``Conditions, or for Treatment
of an Addiction''.
(b) Section Headings.--The section heading of sections 525
through 528 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360aa through 360dd) are amended by striking
``conditions'' and inserting ``conditions, or for treatment
of an addiction''.
(c) Fees.--Section 736(a)(1)(E) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(a)(1)(E)) is amended--
(1) in the subparagraph heading, by striking ``orphan'';
(2) by striking ``for a rare disease or condition'' each
place it appears and inserting ``for a rare disease or
condition, or for treatment of an addiction to illegal
drugs,''; and
(3) in the first sentence, by striking ``rare disease or
condition.'' and inserting ``rare disease or condition, or
other than for treatment of an addiction to illegal drugs,
respectively.''.
TITLE III--ENCOURAGING PRIVATE SECTOR DEVELOPMENT OF PHARMACOTHERAPIES
SEC. 301. DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS
FOR THE TREATMENT OF ADDICTION TO ILLEGAL
DRUGS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by adding at the end the
following:
``Subchapter F--Drugs for Cocaine and Heroin Addictions
``SEC. 571. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR
COCAINE AND HEROIN ADDICTIONS.
``(a) In General.--Subject to subsections (b) and (c), the
Secretary shall, in cooperation with the Institute of
Medicine of the National Academy of Sciences, establish
criteria for an acceptable drug for the treatment of an
addiction to cocaine and for an acceptable drug for the
treatment of an addiction to heroin. The criteria shall be
used by the Secretary in making a contract, or entering into
a licensing agreement, under section 572.
``(b) Requirements.--The criteria established under
subsection (a) for a drug shall include requirements--
``(1) that the application to use the drug for the
treatment of addiction to cocaine or heroin was filed and
approved by the Secretary under this Act after the date of
enactment of this section;
``(2) that a performance based test on the drug--
``(A) has been conducted through the use of a randomly
selected test group that received the drug as a treatment and
a randomly selected control group that received a placebo;
and
``(B) has compared the long term differences in the
addiction levels of control group participants and test group
participants;
``(3) that the performance based test conducted under
paragraph (2) demonstrates that the drug is effective through
evidence that--
``(A) a significant number of the participants in the test
who have an addiction to cocaine or heroin are willing to
take the drug for the addiction;
[[Page S4277]]
``(B) a significant number of the participants in the test
who have an addiction to cocaine or heroin and who were
provided the drug for the addiction during the test are
willing to continue taking the drug as long as necessary for
the treatment of the addiction; and
``(C) a significant number of the participants in the test
who were provided the drug for the period of time required
for the treatment of the addiction refrained from the use of
cocaine or heroin, after the date of the initial
administration of the drug on the participants, for a
significantly longer period than the average period of
refraining from such use under currently available treatments
(as of the date of the application described in paragraph
(1)); and
``(4) that the drug shall have a reasonable cost of
production.
``(c) Review and Publication of Criteria.--The criteria
established under subsection (a) shall, prior to the
publication and application of such criteria, be submitted
for review to the Committee on the Judiciary, and the
Committee on Education and the Workplace, of the House of
Representatives, and the Committee on the Judiciary, and the
Committee on Health, Education, Labor, and Pensions, of the
Senate. Not later than 90 days after notifying each of the
committees, the Secretary shall publish the criteria in the
Federal Register.
``SEC. 572. PURCHASE OF PATENT RIGHTS FOR DRUG DEVELOPMENT.
``(a) Application.--
``(1) In general.--The patent owner of a drug to treat an
addiction to cocaine or heroin, may submit an application to
the Secretary--
``(A) to enter into a contract with the Secretary to sell
to the Secretary the patent rights of the owner relating to
the drug; or
``(B) in the case in which the drug is approved under
section 505 by the Secretary for more than 1 indication, to
enter into an exclusive licensing agreement with the
Secretary for the manufacture and distribution of the drug to
treat an addiction to cocaine or heroin.
``(2) Requirements.--An application described in paragraph
(1) shall be submitted at such time and in such manner, and
accompanied by such information, as the Secretary may
require.
``(b) Contract and Licensing Agreements.--
``(1) Requirements.--The Secretary may enter into a
contract or a licensing agreement described in subsection (a)
with a patent owner who has submitted an application in
accordance with subsection (a) if the drug covered under the
contract or licensing agreement meets the criteria
established by the Secretary under section 571(a).
``(2) Special rule.--The Secretary may, under paragraph
(1), enter into--
``(A) not more than 1 contract or exclusive licensing
agreement relating to a drug for the treatment of an
addiction to cocaine; and
``(B) not more than 1 contract or licensing agreement
relating to a drug for the treatment of an addiction to
heroin.
``(3) Coverage.--A contract or licensing agreement
described in subparagraph (A) or (B) of paragraph (2) shall
cover not more than 1 drug.
``(4) Purchase amount.--Subject to amounts provided in
advance in appropriations Acts--
``(A) the amount to be paid to a patent owner who has
entered into a contract or licensing agreement under this
subsection relating to a drug to treat an addiction to
cocaine shall not exceed $100,000,000; and
``(B) the amount to be paid to a patent owner who has
entered into a contract or licensing agreement under this
subsection relating to a drug to treat an addiction to heroin
shall not exceed $50,000,000.
``(c) Transfer of Rights Under Contracts and Licensing
Agreement.--
``(1) Contracts.--A contract under subsection (b)(1) to
purchase the patent rights relating to a drug to treat
cocaine or heroin addiction shall transfer to the Secretary--
``(A) the exclusive right to make, use, or sell the
patented drug within the United States for the term of the
patent;
``(B) any foreign patent rights held by the patent owner
with respect to the drug;
``(C) any patent rights relating to the process of
manufacturing the drug; and
``(D) any trade secret or confidential business information
relating to the development of the drug, process for
manufacturing the drug, and therapeutic effects of the drug.
``(2) Licensing agreements.--A licensing agreement under
subsection (b)(1) to purchase an exclusive license relating
to manufacture and distribution of a drug to treat an
addiction to cocaine or heroin shall transfer to the
Secretary--
``(A) the exclusive right to make, use, or sell the
patented drug for the purpose of treating an addiction to
cocaine or heroin within the United States for the term of
the patent;
``(B) the right to use any patented processes relating to
manufacturing the drug; and
``(C) any trade secret or confidential business information
relating to the development of the drug, process for
manufacturing the drug, and therapeutic effects of the drug
relating to use of the drug to treat an addiction to cocaine
or heroin.
``SEC. 573. PLAN FOR MANUFACTURE AND DEVELOPMENT.
``(a) In General.--Not later than 90 days after the date on
which the Secretary purchases the patent rights of a patent
owner, or enters into a licensing agreement with a patent
owner, under section 572, relating to a drug under section
571, the Secretary shall develop a plan for the manufacture
and distribution of the drug.
``(b) Plan Requirements.--The plan shall set forth--
``(1) procedures for the Secretary to enter into licensing
agreements with private entities for the manufacture and the
distribution of the drug;
``(2) procedures for making the drug available to nonprofit
entities and private entities to use in the treatment of a
cocaine or heroin addiction;
``(3) a system to establish the sale price for the drug;
and
``(4) policies and procedures with respect to the use of
Federal funds by State and local governments or nonprofit
entities to purchase the drug from the Secretary.
``(c) Applicability of Procurement and Licensing Laws.--
Federal law relating to procurements and licensing agreements
by the Federal Government shall be applicable to procurements
and licenses covered under the plan described in subsection
(a).
``(d) Review of Plan.--
``(1) In general.--Upon completion of the plan under
subsection (a), the Secretary shall notify the Committee on
the Judiciary, and the Committee on Education and the
Workplace, of the House of Representatives, and the Committee
on the Judiciary, and the Committee on Health, Education,
Labor, and Pensions, of the Senate, of the development of the
plan and publish the plan in the Federal Register. The
Secretary shall provide an opportunity for public comment on
the plan for a period of not more than 30 days after the date
of the publication of the plan in the Federal Register.
``(2) Final plan.--Not later than 60 days after the date of
the expiration of the comment period described in paragraph
(1), the Secretary shall publish in the Federal Register a
final plan described in subsection (a). The implementation of
the plan shall begin on the date of the publication of the
final plan.
``(e) Construction.--The development, publication, or
implementation of the plan, or any other agency action with
respect to the plan, shall not be considered agency action
subject to judicial review. No official or court of the
United States shall have power or jurisdiction to review the
decision of the Secretary on any question of law or fact
relating to any agency action with respect to the plan.
``(f) Regulations.--The Secretary may promulgate
regulations to carry out this section.
``SEC. 574. AUTHORIZATION OF APPROPRIATIONS.
``There is authorized to be appropriated to carry out this
subchapter, such sums as may be necessary in each of fiscal
years 2000 through 2002.''.
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