[Congressional Record Volume 142, Number 118 (Tuesday, September 3, 1996)]
[Senate]
[Pages S9743-S9746]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BIDEN:
  S. 2051. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
provide for the development of drugs to treat an addition to illegal 
drugs, and for other purposes; to the Committee on Labor and Human 
Resources.


              THE PHARMACOTHERAPY DEVELOPMENT ACT OF 1996

 Mr. BIDEN. Mr. President, since the first call to arms against 
illegal drugs in 1989, we have learned just how insidious hardcore drug 
addiction is, even as

[[Page S9744]]

the ravages of substance abuse--on both the addict and his 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 
Pharmacotherapy Development Act of 1996, 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, almost 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 physiological and psychological 
characteristics of drug addition 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.
  Private 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 
pharmacotherapy 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 Pharmacotherapy Development Act would encourage and support the 
development of medicines to treat drug addictions in two ways. Both 
approaches are designed to create greater incentives and protections 
for private sector companies willing to undertake this difficult but 
important task.
  First, the bill would provide additional patent protections for 
companies that develop drugs to treat substance abuse. Under the bill, 
pharmacotherapies could be designated ``orphan drugs" and qualify for 
an exclusive 7-year patent to treat a 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 price for the patent rights is established by 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 problem 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 
pharmacotherapy. 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 groundbreaking 
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 to be printed in the 
Record, as follows:

                                S. 2051

       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 ``Pharmacotherapy Development 
     Act of 1996''.
   TITLE I--DEVELOPMENT OF DRUGS FOR THE TREATMENT OF ADDICTIONS TO 
                             ILLEGAL DRUGS

     SEC. 101. 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) by striking ``States'' each place it appears and 
     inserting ``States, or for treatment of an addiction to 
     illegal drugs''; and
       (2) by striking ``such disease or condition'' each place it 
     appears and inserting ``such disease, condition, or treatment 
     of such addiction''.

[[Page S9745]]

     SEC. 102. 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,''; and
       (C) by striking ``such disease or condition'' each place it 
     appears and inserting ``such disease, 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 thereof the following new 
     subparagraphs:
       ``(B) The term `treatment of an addiction to illegal drugs' 
     means 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 drug abuse for an individual described in clause 
     (i);
       ``(iv) moderates or eliminates the process of withdrawal 
     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 drug 
     abuse 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 Substance Act (21 U.S.C. 812(c)).''.

     SEC. 103. PROTECTION FOR DRUGS.

       Section 527 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360cc) is amended--
       (1) by striking ``rare disease or condition'' each place it 
     appears and inserting ``rare disease or condition or for 
     treatment of an addiction to illegal drugs'';
       (2) by striking ``such disease or condition'' each place it 
     appears and inserting ``such disease, condition, or treatment 
     of the addiction''; and
       (3) in subsection (b)(1), by striking ``the disease or 
     condition'' and inserting ``the disease, condition, or 
     addiction''.

     SEC. 104. 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''.
 TITLE II--DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS FOR THE 
               ADDICTION OF COCAINE AND HEROIN ADDICTIONS

     SEC. 201. DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS 
                   FOR THE TREATMENT OF ADDICTIONS 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 thereof 
     the following new subchapter:

        ``Subchapter D--Drugs for Cocaine and Heroin Addictions

     ``SEC. 551. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR 
                   COCAINE AND HEROIN ADDICTIONS.

       ``(a) In General.--Subject to the provisions of subsections 
     (b) and (c), the Secretary shall, through 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 to a 
     licensing agreement, under section 552.
       ``(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;
       ``(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 for a period of 3 years after the date of 
     the initial administration of the drug on the participants; 
     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 Economic and Educational Opportunities of the 
     House of Representatives, and the Committee on the Judiciary 
     and the Committee on Labor and Human Resources 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. 552. 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 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 Agreement.--
       ``(1) Requirements.--The Secretary shall enter into a 
     contract or a licensing agreement with a patent owner who has 
     submitted an application in accordance with (a) if the drug 
     covered under the contract or licensing agreement meets the 
     criteria established by the Secretary under section 551(a).
       ``(2) Special rule.--The Secretary shall 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.

     A contract or licensing agreement described subparagraph (A) 
     or (B) shall cover not more than 1 drug.
       ``(3) Purchase amount.--Subject to appropriations--
       ``(A) the amount to be paid to a patent owner who has 
     entered into a contract or licensing agreement under this 
     subsection relating a drug to treat an addiction to cocaine 
     shall be $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 a drug to treat an addiction to heroin 
     shall be $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;
       ``(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.

[[Page S9746]]

     ``SEC. 553. 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, relating to a drug under section 551, 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.--The 
     procurement and licensing laws of the United States 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 Economic and Educational 
     Opportunities of the House of Representatives, and the 
     Committee on the Judiciary and the Committee on Labor and 
     Human Resources 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. The implementation of the plan shall begin on the 
     date of the final publication of the 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.
       ``(f) Regulations.--The Secretary may promulgate 
     regulations to carry out this section.

     ``SEC. 554. AUTHORIZATION OF APPROPRIATIONS.

       ``There are authorized to be appropriated to carry out this 
     subchapter, such sums as may be necessary in each of the 
     fiscal years 1997 through 1999.''.

                          ____________________