[Congressional Record Volume 144, Number 51 (Thursday, April 30, 1998)]
[Senate]
[Pages S3932-S3933]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BIDEN:
  S. 2015. 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 Labor and Human Resources.


            THE NEW MEDICINES TO TREAT ADDICTION ACT OF 1998

  Mr. BIDEN. Mr. President, today I am introducing the New Medicines to 
Treat Addiction Act of 1998, 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 in 1989, we have 
learned just how insidious hardcore drug addiction is, even as 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 New 
Medicines To Treat Addiction Act of 1998, 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

[[Page S3933]]

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 New Medicines to Treat Addiction Act would encourage and support 
the development of medicines to treat drug addiction in three ways.
  It reauthorizes and increases funding for the Medications Development 
Program at the National Institute of Health, which for years has been 
at the forefront of research into drug addiction.
  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 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 seven-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 ground breaking, 
approach to addressing one of our nation's most serious domestic 
challenges.
                                 ______