STATEMENT BY

                 RANDOLPH F. WYKOFF, MD, MPH, TM

          DIRECTOR OF THE OFFICE OF AIDS COORDINATION 


                  FOOD AND DRUG ADMINISTRATION

                      PUBLIC HEALTH SERVICE

             DEPARTMENT OF HEALTH AND HUMAN SERVICES

                           BEFORE THE


                   COMMITTEE ON THE JUDICIARY


           SUBCOMMITTEE ON CRIME AND CRIMINAL JUSTICE


                     HOUSE OF REPRESENTATIVES


                          MAY 27, 1993

Mr. Chairman, I am Dr. Randolph F. Wykoff, the Director of the
Office of AIDS Coordination and the Acting Associate Commissioner
for Science, Food and Drug Administration (FDA).  With me are Mr.
Daniel L. Michels, Director of FDA's Office of Enforcement, Mr.
Terrell L. Vermillion, Director of FDA's Office of Criminal
Investigations, and Mr. Robert M. Spiller, Associate Chief
Counsel for Enforcement.  I sincerely appreciate the opportunity
to address your Subcommittee on the important issue of health
fraud and AIDS.

Let me state succinctly at the outset the philosophy guiding the
Food and Drug Administration (FDA) in this area.  We are
committed to providing people with life-threatening diseases
access to the most promising therapies.  This commitment in no
way diminishes our responsibility to be vigilant -- consistent
with the consumer protection goals of the statutes we enforce --
to the potential for health fraud.  We will draw the line, and
indeed, will not tolerate anyone who would exploit the victims of
these diseases for personal gain.

As you know, AIDS is a public health crisis that has resulted in
the death of tens of thousands of Americans.  It is a disease
that is believed to be always fatal and, despite the fact that we
have approved over a dozen agents for the treatment of HIV/AIDS
and HIV-related conditions, there is no cure or preventive
vaccine on the horizon.  It is entirely understandable, then,
that people with AIDS are aggressively seeking access to any
potentially promising therapy.

At the FDA, we have implemented a number of changes in order to
provide people with AIDS the broadest possible access, through
legal means, to promising products.  While these changes have
taken many forms, three bear mentioning today:

First, we have implemented a variety of mechanisms to expand
access to promising investigational agents prior to approval. 
Through these programs, people who have not been helped by
existing therapies can have access to the most promising, but as
yet unproven, investigational drugs.

Second, we have implemented mechanisms such as accelerated
approval that have made it possible for us to review and, where
appropriate, to approve drugs for HIV and HIV-related conditions
in record time.

Third, we have clarified and articulated a long-standing FDA
enforcement policy for personal use importation under which
individuals may import for personal use small quantities of
unapproved drugs for the treatment of life-threatening diseases
such as AIDS.

In all of these initiatives, we have worked closely, and
communicated frequently, with people with AIDS and their
advocates.  The underlying principle for these initiatives is the
recognition that for people with terminal illnesses, who lack
satisfactory alternative therapies, promising investigational
agents offer hope.  But access without appropriate safeguards
against fraud may offer little more than false hope.

Earlier this week we sent a letter to all known AIDS buyers'
clubs -- groups which facilitate patient access to drugs and
other products purportedly useful in treating AIDS and related
diseases.  In this letter, we repeated our commitment to working
with the communities impacted by AIDS to identify truly
promising, but as yet unproven, products that could become
available through legal means.  We also indicated our willingness
to allow continuation of the beneficial aspects of the personal
use importation policy, as long as abuses of the policy are
prevented.  We have done this to provide people with AIDS with
access to truly promising products while protecting them from the
kinds of health fraud that are the mutual concern of this
Subcommittee, the FDA, and the AIDS community.  

In our letter, we also listed three areas where we believe that
the line separating reasonable access to truly promising agents
from outright health fraud is crossed.  

First, we stated our belief that no one's well-being is served by
having access to a product for a serious disease without the
active oversight of a licensed physician.

Second, we stated that promotion and commercialization of
unapproved products, in our experience, are frequently
characteristics of the kinds of deception and health fraud that
expose people with life-threatening conditions to ineffective and
dangerous products.

Third, we stated our concern about products that are manufactured
at unknown sources or under unknown manufacturing conditions. 
These products have an increased risk of contamination, variable
potency, and lack of quality assurance that represent a
substantial hazard for individuals with serious diseases,
particularly those with weakened immune systems.

Mr. Chairman, we realize a tension may appear to exist between
our commitment to providing dying patients with access to the
most promising products, and our responsibility to protect those
very same people from dangerous and fraudulent products.  We
believe our approach -- allowing access under appropriate
circumstances, while being vigilant against cases of outright
fraud -- is sound.

To understand this, it may be helpful to envision the access to
an unapproved drug as falling on a spectrum.  At one end of the
spectrum is a situation in which a knowledgeable and
compassionate physician has a patient with a life-threatening
disease who has exhausted all approved therapeutic alternatives. 
The physician and patient make an informed decision to try a
promising, but as yet unapproved therapy, which is used under
careful supervision and controlled circumstances.

The other end of the same spectrum is where an unscrupulous
person preys on the terminally ill patient and, for personal
profit or self aggrandizement, exposes that patient to a
fraudulent product.  This is the classic snake oil salesman, the
financially motivated shark that feeds on the desperation of
dying people.  This is an obscenity all can recognize as a crime.

In making our enforcement decisions, we must draw a line on this
spectrum.  To this end, we must direct our enforcement activities
towards those actions and activities that pose the greatest risk
to the public health. 

Let me give you some examples of what we believe are clearly
egregious threats to the public health in which we have taken
action.  

    "CanCell" is water that has been "energized" by a plant.  It
     has been promoted to have a high cure rate for all types of
     cancer, plus diabetes, arthritis, lupus, and, more recently,
     AIDS.  Several studies were attempted to evaluate the
     product.  However, none showed any therapeutic benefit. 
     After an FDA investigation, the government filed a complaint
     for permanent injunction on February 21, 1989, to enjoin the
     purveyors from distributing CanCell.  

    FDA received a complaint about a "cure" for AIDS which was
     being promoted by two physicians in Tennessee.  The
     physicians used the guise of a clinical investigation in an
     attempt to gain credibility.  The physicians charged $10,000
     for each stage of a one to three stage therapy and told the
     victims to discontinue standard therapy.  The physicians
     were administering drugs for which there was no medical
     basis to believe they would be useful in treating AIDS. 
     While FDA conducted the investigation, we determined it
     would be the most efficient use of our enforcement resources
     to work with the State of Tennessee to put an end to the
     scam.  The medical license of one physician was revoked and
     the other was told not to practice anything except
     psychiatry.

    Ozone therapy has also been used to treat AIDS patients
     without any scientific data to support the agent's safety or
     effectiveness.  Ozone therapy and ozone generators have been
     promoted in magazines and newspaper advertisements and in
     books, videos, and audio cassettes.  The introduction of
     ozone into immunosuppressed AIDS patients without careful
     study of probable toxicities places the patients at
     unreasonable and significant risks.

     FDA is currently involved in litigation with some ozone
     generator distributors.  Because the litigation is ongoing,
     we will not describe the details of those cases.

    FDA obtained a permanent injunction against Vital Health
     Products, LTD, Muskego, Wisconsin, which was promoting and
     selling hydrogen peroxide products for, among other uses, 
     the treatment of AIDS.  These products were found to be both
     misbranded drugs and unapproved new drugs.

    There have also been a number of cases of AIDS fraud
     accomplished by promoters making substantial unwarranted
     claims for otherwise relatively safe products.  To stop the
     unsupported AIDS claims, though not necessarily remove the
     product from the market, we have responded with warning
     letters and other enforcement approaches.

Mr. Chairman, let me say that it is clear that there are people
who are willing to expose dying AIDS patients to false hope,
poverty, and very real personal danger, for their own personal
gain.
  
We must work together to stop health fraud in AIDS and in all
serious and life-threatening diseases.  The government must have
the proper criminal law enforcement tools.  For your information,
I have appended to my testimony a description of FDA's current
authority in this area.  

The most important tool to stop health fraud is community
vigilance.  People seeking AIDS treatments or preventatives can
protect themselves against fraudulent promoters by watching for:

    Anyone who claims to be able to cure an incurable disease.

    Promotions that include words such as "miraculous,"
     "secret," "suppressed," or foolproof."  

    Experimental treatments that you have to pay for.

    Products that have only testimonials and no scientific
     evidence. 

    Products that claim to be cures for multiple diseases --
     especially cancer, AIDS, aging, and so on.

    Products obtained and used without your physician.

    Products that require individuals to discontinue standard
     therapy.

All of us must have the commitment and mutual trust to help
prevent dying people from becoming victims of fraud.  The
challenge is not simple.  The answer is not easy.  But the threat
is too great to ignore.  In order to succeed, we must work
together to stop AIDS health fraud.  People with AIDS deserve no
less.  We cannot halt the disease yet, but we can stop some of
the cruel fraud on its victims, and help our population to
concentrate its hope and spending on potential helpful therapies.

We, at the FDA, will leave no stone unturned to get truly
promising treatments into the hands of people with AIDS.  There
is no greater challenge to the public health and consumer
protection missions of our Agency than expanding access to
genuine agents of hope, while ferreting out the hoaxes and shams.

Thank you for the opportunity to appear before this Subcommittee. 
I look forward to answering any questions that you may have.


                        TESTIMONY APPENDIX
                      May 27, 1993, Hearing
      FDA's Health Fraud Authority and Enforcement Program

The Food and Drug Administration's (FDA) authority to help
eliminate health fraud comes primarily from various provisions of
the Federal Food, Drug, and Cosmetic (FDC) Act.  For example, the
FDC Act prohibits the introduction into interstate commerce of
any food, drug, device or cosmetic that is adulterated or
misbranded (21 U.S.C. 331(a)).  The statute also prohibits the
introduction into interstate commerce of an unapproved new drug
(21 U.S.C. 331(d)).  FDA can initiate court actions to seize
violative products and injunctions to stop violative behavior (21
U.S.C.  334, 332).  Violating FDC Act provisions with intent to
defraud is a felony (21 U.S.C.  333(a)(2)).  FDA, together with
the Federal Trade Commission (FTC), also regulates the
advertising and labeling that makes the products misbranded. 

FDA has, over time, developed a strategy to make the most
effective use of limited resources for dealing with products that
represent health fraud.  Until the 1960's, a common tool used by
the Agency was criminal prosecution.  Since then, the Agency has
expanded its enforcement program to include the use of other
administrative and judicial measures such as seizures, warning
letters, injunctions, import detentions, administrative detention
of medical devices, and recently, under the Safe Medical Devices
Act of 1990, civil penalties and mandatory recalls.  

As part of the Agency's enforcement program, which includes
routine inspections, FDA also investigates individual complaints,
obtains information, and collects evidence regarding potential
violations of the FDC Act.  Decisions as to the significance of
these findings and what action should result are made in
accordance with established compliance policy, which reflects
factors such as health hazard potential, extent of product
distribution, nature of the misbranding, jurisdiction of other
agencies, and available resources.  Whenever possible, FDA also
coordinates its investigations and enforcement strategies with
other federal and State consumer protection agencies.

To complement the regular field force, FDA established an Office
of Criminal Investigations (OCI) in March 1992 to focus
exclusively on investigating potential criminal offenses.  To
accomplish its mission, FDA/OCI has recruited approximately 100
special agents from FDA and other federal law enforcement
agencies.  The success of our initial recruitment efforts has
provided OCI with a diverse group of talented federal agents with
an average of 12 years of law-enforcement experience.  OCI's
first three field offices opened in January of this year, and the
remaining three offices will open next month.  The Agency expects
the creation of OCI to significantly enhance FDA's ability to
investigate health fraud, including AIDS-related fraud.  

In addition, two years ago FDA's National Health Fraud Task Force
launched a program to monitor suspected fraudulent AIDS products
and therapies in the states most affected by the AIDS epidemic. 
A major emphasis is placed on providing support for existing
State AIDS Tasks Forces.  To date, six such groups have been
established, in Michigan, Colorado, Texas, Georgia, Louisiana,
and California.
                              ####

Office of Special Health Issues, HF-12