[Congressional Record Volume 143, Number 44 (Tuesday, April 15, 1997)]
[Senate]
[Pages S3206-S3210]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GLENN (for himself and Mr. Lieberman):
  S. 577. A bill to increase the efficiency and effectiveness of the 
Federal Government, and for other purposes; to the Committee on 
Governmental Affairs.


          the government restructuring and reform act of 1997

  Mr. GLENN. Mr. President, I rise today to introduce the Government 
Restructuring and Reform Act of 1997, legislation whose objective is to 
reorganize the executive branch into a form and a structure that is 
capable of meeting the challenges of the 21st century. The bill is 
cosponsored by my distinguished colleague from Connecticut, Senator 
Lieberman.
  We are in an era of contraction at the Federal level. Some of this 
contraction is needed in my opinion, in some areas I don't think it's a 
good idea. But it is a fact. Many programs are being cut, others have 
been eliminated or consolidated into block grants to the States. 
Agencies and departments are being downsized and in some cases 
eliminated. In the last Congress, the Bureau of Mines, Office of 
Technology Assessment, Interstate Commerce Commission, and Advisory 
Commission on Intergovernmental Relations were all terminated. In 
addition, agency rules and paperwork are being pruned. And Federal 
employment has been cut by over 250,000 positions in the last 4 years 
and continues to fall.
  These are big and historic changes, spurred on by our efforts to 
reach a balanced budget and the desire of the American people for a 
more cost-effective Government.
  However, despite the overall downsizing effort, the basic structure 
of the Federal Government remains unchanged. In fact, the basic 
structure of the Federal Government has changed little in the last 25 
years, despite structural changes in the private sector, the economy, 
and our society over that same time period. The Federal Government has 
been the last to follow suit--and that's as it should be in a 
democracy--but that does not mean it should be immune from change 
forever. We cannot keep the status quo in the existing executive branch 
structure while continuing to downsize, cut budgets and programs and 
reduce personnel levels and also expect these same Federal agencies to 
perform effectively and maintain adequate levels of service. We'll end 
up with what I call the hollowing out of Government. We'll have the 
same agencies and departments in place doing most of the same 
activities as they do now. But with less money and less people on hand, 
these activities will be carried out less effectively. We'll have a 
less costly Federal

[[Page S3207]]

Government, but not a more cost-effective one. That is, unless we 
address reorganization and consolidation of Federal agencies and 
functions in a comprehensive, well-thought-out way.
  Reorganization issues are very difficult, perhaps among the most 
difficult issues we face in Government. It raises questions that don't 
have simple, right and wrong answers. Should we have greater 
centralization of Government functions in less, but larger Cabinet 
departments? This is the traditional, centralized model of how 
Government bureaucracy is organized. Or should we decentralize and 
spread Government functions across many smaller agencies and 
departments? Such an approach fits what many call the entrepreneurial 
model of Government organization.
  Well, I can think of pros and cons to both approaches. To add to this 
difficulty, reorganization necessarily involves questions of turf and 
jurisdiction. Turf battles in this town are as hotly contested as any 
policy issue. I know this through experience. Several years ago I 
proposed consolidating the Government's trade and technology functions 
into one Cabinet department and I faced very stiff opposition. 
Likewise, turf is just as jealously guarded at the other end of 
Pennsylvania Avenue. Ask the President's National Performance Review. 
They proposed integrating the Agency for International Development into 
the State Department in addition to consolidating the Federal law 
enforcement agencies only to be faced down by the bureaucracy. So I 
don't think comprehensive reorganization can be tackled successfully by 
either the Congress or the executive branch.

  That's why I'm in favor of establishing a Government commission to 
examine executive branch organization. My bill establishes a nine-
member, bipartisan Commission to make recommendations to the President 
and the Congress in 2 years on consolidating, eliminating, and 
restructuring Federal departments and agencies in order to eliminate 
unnecessary activities, reduce duplication across programs, and improve 
management and efficiency. This Commission would be not just any old 
Commission, producing some big thick study that would wind up largely 
unread in some recycling bin, or on the dusty shelf of academia. Rather 
the Commission's recommendations would be submitted to the Congress and 
have to be considered on a what I call a flexible fast-track basis. 
They could not perish in committee, as so often occurs with commission 
reports and recommendations.
  There is precedent for such a commission. In fact, the few successful 
Government reorganization efforts that have taken place have come about 
because of the work of a commission. Let me give you some background.
  The Hoover Commission is probably the most famous Government 
restructuring commission from recent times. It was formed in 1947 and 
chaired by former President Hoover. The 12-member commission operated 
until 1949 and issued 19 reports to the President recommending various 
changes in the structure of the Federal Government. From these 
recommendations, President Truman submitted eight reorganization plans 
to Congress in 1949, of which six became effective. The following year 
he submitted 27 reorganization plans, 20 of which became effective. 
Included among these plans were the creation of the General Services 
Administration, the expansion of the Executive Office of the President, 
and the creation of a centralized Office of Personnel.
  A second Hoover Commission was formed in 1953 and made 314 specific 
recommendations over the following 2 years, 202 of which were 
implemented. However, generally this Commission was not considered as 
successful as the first Hoover Commission, as it engaged itself in more 
controversial matters of policy rather than solely focus on management 
and organization as the first commission had done.
  Our next restructuring effort of note was put forward by President 
Nixon's Ash Council, which was in operation from 1969 to 1971. Headed 
by Roy Ash, chairman of Litton Industries, the Council supplied the 
President with nine memoranda detailing with specific reorganization 
and consolidation proposals. The Council recommended the formation of 
OMB, the EPA, and NOAA from the consolidation of existing programs. 
These proposals were all implemented. The Council also recommended the 
creation of several super-Departments, including a Department of 
Natural Resources, but these proposals ultimately did not pass the 
Congress.
  The next notable Commission came during the Reagan years, the Grace 
Commission, which was established by Executive order in 1982 and was in 
operation through 1984. The panel was composed of 161 corporate 
executives and it issued a massive 47 volume report with nearly 2,500 
recommendations. Many of its recommendations were policy-based rather 
than organizational in nature, hence they generated controversy and 
polarized debate in the Congress. Still, many of the recommendations 
were implemented, primarily through executive branch action. And the 
Commission did call for stronger financial management in the Federal 
bureaucracy. That's something we have built on in the Committee on 
Governmental Affairs through enactment of the Chief Financial Officers 
Act.

  More recently, the Committee on Governmental Affairs passed 
legislation to establish a bipartisan reorganization commission as part 
of our efforts to make the VA a Cabinet department. That Commission 
became law, Unfortunately, in order to pass it, we had to place a 
mechanism to trigger the activation of the Commission through a 
Presidential certification that the Commission was in the national 
interest. Unfortunately, that certification was not made, Had it been, 
perhaps we would have in place today the blueprint for the Government 
of the 21st century.
  Then in the 103d Congress, we reported out a Glenn-Roth-Lieberman 
Commission bill by a 12 to 1 vote. But we did not move it to the floor 
because the President's National Performance Review was just getting 
underway and we wanted to see what it might come up with before 
establishing the commission.
  Finally, last year the committee reported out a version of a 
government reorganization commission; however, it was tied to 
legislation dismantling the Commerce Department and thus died. Late in 
the session, Senator Stevens developed a substitute retaining the 
commission but dropping the dismantling provisions, We came close to an 
agreement and my hope this Congress is that we will reach one.
  For a more detailed history of government restructuring commissions I 
would refer my colleagues to an excellent report prepared by CRS titled 
``Reorganizing the Executive Branch in the Twentieth Century: Landmark 
Commissions.''
  I believe that a commission would complement nicely the efforts of 
the NPR. The Federal work force has been reduced by over 250,000 
positions, Federal paperwork and redtape has been simplified, 
procurement reform has been enacted, and unnecessary field offices at 
the Department of Agriculture has been closed. These accomplishments 
are due in significant part to the work and the efforts of the NPR.
  However, the NPR has generally not focused on government restricting. 
In the instances where it has made proposals--I noted two examples 
earlier in my statement--they have been rebuffed by the bureaucracy, 
the Congress or both.
  Recent congressional efforts have fallen short also, as several of my 
colleagues learned in advocating the dismantling of four Cabinet 
departments--HUD, DOE, Commerce, and Education. Those efforts were 
heavy-handed in my view and would have created more problems then they 
would have solved.
  In closing, I believe an examination of the experience of the private 
sector in restructuring and downsizing is instructive in 
differentiating between the right and wrong ways to downsize. A 1993 
survey of over 500 U.S. companies by the Wyatt Co. revealed that only 
60 percent of the companies actually were able to reduce costs in their 
restrucuting efforts. Both the Wyatt Survey and a similar one conducted 
by the American Management Association concluded that successful 
restructuring efforts must be planned carefully with a clear vision of 
their goals and objectives, and that proper attention be given to 
maintaining employee morale

[[Page S3208]]

and productivity. Otherwise, the costs of reorganization may outweigh 
its benefits.
  There is a right and a wrong way to reorganize and downsize. I 
believe that the Commission approach is the right way. I hope my 
colleagues will support this legislation.
  Mr. President, I ask unanimous consent that additional material be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

     Summary of the Government Restructuring and Reform Act of 1997


                                mission

       To consolidate, eliminate and reorganize Federal government 
     departments, agencies and programs to improve efficiency and 
     effectiveness, streamline operations and eliminate 
     unnecessary duplication. To strengthen management capacity. 
     To propose criteria for government-sponsored corporations. To 
     define new/reorganized agency missions and responsibilities.


                               membership

       Nine Members (No more than five from any one party). Three 
     Members (including Chair) appointed by the President 
     (Chairman is selected in consultation with the respective 
     Republican and Democratic leaders of the House and Senate). 
     Six Members appointed by the Congress (1 each for each party 
     leader, then 1 by Speaker in concurrence with Sen. Majority 
     Leader and 1 by Sen. Minority Leader in concurrence with 
     House Minority Leader). Appointments made within 90 days of 
     enactment. Six Members must be in agreement for the 
     Commission to approve any recommendation.


                                reports

       President may submit his own recommendations (7/1/98) for 
     the Commission to consider. Commission issues a preliminary 
     (due 12/1/98) and final report (8/1/99) to the President, 
     Congress, and the public. Public hearings must be held and 
     the Commission is subject to FACA. President has 30 days to 
     suggest changes to final report. The final report is 
     forwarded to Congress by 10/1/99.


                              legislation

       ``Flexible'' fast-track process is in place. Commission 
     final report is introduced as one single bill and Committees 
     have 30 legislative days to act or bill is discharged. Bill 
     is then placed on the Senate calender and after 5th 
     legislative day it is in order to proceed to consideration of 
     the bill. Bill can be filibustered or amended (must be 
     relevant). Fast track procedures apply for the House as well. 
     House-Senate conferees then have 20 days to report.


                              funds/tenure

       $5 M per yr. Sunsets by 10/1/99.
      By Mr. DASCHLE (for himself, Mr. Harkin, Mr. Hatch, Mr. Grassley, 
        Mr. Abraham, Mr. Reid, Mr. Inouye, Mr. Baucus, Mr. Craig, Mr. 
        Kempthorne, and Mr. Thomas):
  S. 578. A bill to permit an individual to be treated by a health care 
practitioner with any method of medical treatment such individual 
requests, and for other purposes; to the Committee on Labor and Human 
Resources.


                  the access to medical treatment act

  Mr. DASCHLE. Mr. President, today I am introducing the Access to 
Medical Treatment Act. I am pleased to be joined by Senators Harkin, 
Hatch, Grassley, Reid, Abraham, Inouye, Baucus, Craig, Kempthorne, and 
Thomas in this effort to allow greater freedom of choice in the realm 
of medical treatments.
  I was introduced to the alternative medical treatment debate the same 
way many Americans are: through personal experience. Actually, in my 
case it was the experience of a personal friend: Berkley Bedell.
  Berkley Bedell, as many of you know, is a former Congressman from 
Iowa's 6th District. He is also--since his battle with Lyme disease 
several years ago--a tireless advocate for improving access to 
alternative treatments.
  As some may remember, Congressman Bedell was ill with Lyme disease 
when he left the House at the end of the 100th Congress. Having tried 
several unsuccessful rounds of conventional treatment consisting of 
heavy doses of antibiotics over approximately 4 years, he turned to an 
alternative treatment that he believes cured his disease.
  This treatment consisted on its most basic level of nothing more than 
drinking processed whey from a cow's milk. After about 2 months of 
taking regular doses of this processed whey, his symptoms disappeared.
  Despite Congressman Bedell's amazing recovery, and the fact that this 
same treatment appeared to be effective in treating other cases of Lyme 
disease, the treatment can no longer be administered because it has not 
gone through the FDA approval process.
  Congressman Bedell's story--and others I have heard since--have 
convinced me of two things: first, that our health care system actually 
discourages the development and use of alternative medical treatments; 
and second, that this myopic outlook does not serve the best interest 
of the American people.
  As I looked into the potential of alternative therapies, I was struck 
by what appears to be a deep-seated skepticism of alternative 
treatments within the medical establishment that may be impeding their 
use. It is clear to me that the public would benefit by greater debate 
about the value of alternative medical treatments, and it is to 
stimulate that debate and ultimately remove barriers to potentially 
effective treatments that I have reintroduced the Access to Medical 
Treatment Act.
  This legislation would allow individual patients and their physicians 
to use certain alternative and complementary therapies not approved by 
the FDA. A companion measure has been introduced in the House by 
Representative DeFazio and 43 of his colleagues.
  Mr. President, it has been my experience that efforts to expand 
access to alternative treatments often produce strong emotional 
reactions--on both sides of the issue. Sometimes, those reactions are 
so strong they detract from the merits of the debate.
  Therefore, let me clarify the intent of the Access to Medical 
Treatment Act.
  This bill is intended to promote greater access to alternative 
therapies under the supervision of licensed health practitioners and 
under carefully circumscribed guidelines. Hopefully, it will stimulate 
a constructive discussion of how best to achieve this objective.
  I appreciate the natural inclination to be wary of uncharted waters, 
and I am not suggesting that caution be thrown to the wind in the case 
of alternative therapies. Some have expressed concern that this bill 
could have the unintended effect of opening the door to unscrupulous 
entrepreneurs who seek to make profit on the despair of the sick. I 
don't minimize that concern. How to guard against such an unintended 
consequence is an issue we will want to examine closely and address.
  What I am suggesting, however, is that this concern should not blind 
us to the benefit and potential of alternative medicine. It is not a 
reason to shrink from the challenge of expanding access to alternative 
therapies.
  Alternative therapies constitute a legitimate field of endeavor that 
is an accepted part of medicine taught in at least 22 of the Nation's 
125 medical schools, including such prestigious institutions as 
Harvard, Yale, Columbia, Johns Hopkins, Georgetown, Albert Einstein, 
Mount Sinai, UCLA, and the University of Maryland.
  At the National Institutes of Health's Office of Alternative 
Medicine, scientists are working to expand our knowledge of alternative 
therapies and their safe and effective use.
  And the State medical licensing boards now have a committee 
discussing alternative medicine. I encourage that panel to explore how 
safe access to alternative medicine might be increased.
  Additionally, more and more Americans are turning to alternative 
therapies in those frustrating instances in which conventional 
treatments seem to be ineffective in combating illness and disease. In 
1990 alone, the New England Journal of Medicine found that Americans 
spent nearly $14 billion on alternative therapies, and made more visits 
to alternative practitioners than they did to primary care doctors. 
American consumers are turning to these therapies because they are 
perceived to be a less expensive and more prevention-based alternative 
to conventional treatments.

  Given the popularity of alternative therapies among the American 
public, it will be asked why this legislation is necessary. If a 
particular alternative treatment is effective and desired by patients, 
then why can't it simply go through the standard FDA approval process?
  The answer is that the time and expense currently required to gain 
FDA approval of a treatment makes it very

[[Page S3209]]

difficult for all but large pharmaceutical companies to undertake such 
an arduous and costly endeavor. The heavy demands and requirements of 
the FDA approval process, and the time and expense involved in meeting 
them, serve to limit access to the potentially innovative contributions 
of individual practitioners, scientists, smaller companies, and others 
who do not have the financial resources to traverse the painstakingly 
detailed path to certification.
  Thus, the current system has the unfortunate effect of both 
discouraging the exploration of life-saving treatments and preventing 
low-cost treatments from gaining access to the market. The Access to 
Medical Treatment Act attempts to open the door to promising treatments 
that may not have huge financial backing.
  I want to be absolutely clear, however, that this legislation will 
not dismantle the FDA, undermine its authority or appreciably change 
current medical practices. It is not meant to attack the FDA or its 
approval process. It is meant to complement it.
  The FDA should--and would under this legislation--remain solely 
responsible for protecting the health of the Nation from unsafe and 
impure drugs. The heavy demands and requirements placed upon treatments 
before they gain FDA approval are important, and I firmly believe that 
treatments receiving the Federal Government's stamp of approval should 
be proven safe and effective.
  The real question posed by this legislation is whether it is in the 
public interest to simply forgo the potential benefits of alternative 
treatments because of economies of scale, or whether, working with the 
FDA, it makes sense to explore ways to bring such treatments to the 
marketplace.
  Mr. President, the Access to Medical Treatment Act proposes one way 
to extend freedom of choice to medical consumers under carefully 
controlled situations. It suggests that individuals--especially those 
who face life-threatening afflictions for which conventional treatments 
have proven ineffective--should have the option of trying an 
alternative treatment, so long as they have been fully informed of the 
nature of the treatment, potential side effects and any other 
information necessary to fully meet FDA informed consent requirements. 
This is a choice that is rightly left to the consumer, and not dictated 
by the Federal Government.

  The bill requires that a treatment be administered by a properly 
licensed health care practitioner who has personally examined the 
patient. It requires the practitioner to comply fully with FDA informed 
consent requirements. And it strictly regulates the circumstances under 
which claims regarding the efficacy of a treatment can be made.
  No advertising claims can be made about the efficacy of a treatment 
by a manufacturer, distributor, or other seller of the treatment. 
Claims may be made by the practitioner administering the treatment, but 
only so long as he or she has not received any financial benefit from 
the manufacturer, distributor, or other seller of the treatment. No 
statement made by a practitioner about his or her administration of a 
treatment may be used by a manufacturer, distributor, or other seller 
to advance the sale of such treatment.
  What this means is that there can be no marketing of any treatment 
administered under this bill. As such, there should be little incentive 
for anyone to try to use this bill as a bypass to the process of 
obtaining FDA approval. Also, because only properly licensed 
practitioners are able to make any claims at all about the efficacy of 
a treatment, there should be little room for so-called quack medicine. 
In short, if an individual or a company wants to earn a profit off 
their product, they would be wise to go through the standard FDA 
approval process rather than utilizing this legislation.
  In essence, this legislation addresses the fundamental balance 
between two seemingly irreconcilable interests: the protection of 
patients from dangerous treatments and those who would advocate unsafe 
and ineffective medicine--and the preservation of the consumer's 
freedom to choose alternative therapies.
  The complexity of this policy challenge should not discourage us from 
seeking to solve it. I am convinced that the public good will be served 
by a serious attempt to reconcile these contradictory interests, and I 
am hopeful the discussion generated by introduction of this legislation 
will help point the way to its resolution. I welcome anyone who would 
like to join me in promoting this important debate to cosponsor this 
legislation. I also welcome alternative suggestions for accomplishing 
this objective.
  As I mentioned previously, I am sympathetic to the concern about the 
need to protect patients against unscrupulous practitioners. 
Individuals are often at their most vulnerable when they are in 
desperate need of medical treatment. That is why it is absolutely 
critical that a proposal of this nature include strong protections to 
ensure that patients are not subject to charlatans who would prey on 
their misfortunate and fears for personal gain. The Access to Medical 
Treatment Act contains such protections.
  Mr. President, this legislation represents an honest attempt to focus 
serious attention on the value of alternative treatments and overcome 
current obstacles to their safe development and utilization. If there 
is a better way to make alternative therapies available to people 
safely, let's find that way. But let's continue this discussion and get 
the job done.
  I ask unanimous consent that the text of the Access to Medical 
Treatment Act be printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 578

       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 ``Access to Medical Treatment 
     Act''.

     SEC. 2. DEFINITIONS.

       In this Act:
       (1) Advertising claims.--The term ``advertising claims'' 
     means any representations made or suggested by statement, 
     word, design, device, sound, or any combination thereof with 
     respect to a medical treatment.
       (2) Danger.--The term ``danger'' means any negative 
     reaction that--
       (A) causes serious harm;
       (B) occurred as a result of a method of medical treatment;
       (C) would not otherwise have occurred; and
       (D) is more serious than reactions experienced with 
     routinely used medical treatments for the same medical 
     condition or conditions.
       (3) Device.--The term ``device'' has the same meaning given 
     such term in section 201(h) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(h)).
       (4) Drug.--The term ``drug'' has the same meaning given 
     such term in section 201(g)(1) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(g)(1)).
       (5) Food.--The term ``food''--
       (A) has the same meaning given such term in section 201(f) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(f)); and
       (B) includes a dietary supplement as defined in section 
     201(ff) of such Act.
       (6) Health care practitioner.--The term ``health care 
     practitioner'' means a physician or another person who is 
     legally authorized to provide health professional services in 
     the State in which the services are provided.
       (7) Label.--The term ``label'' has the same meaning given 
     such term in section 201(k) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 321(k)).
       (8) Labeling.--The term ``labeling'' has the same meaning 
     given such term in section 201(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321(m)).
       (9) Legal representative.--The term ``legal 
     representative'' means a parent or an individual who 
     qualifies as a legal guardian under State law.
       (10) Medical treatment.--The term ``medical treatment'' 
     means any food, drug, device, or procedure that is used and 
     intended as a cure, mitigation, treatment, or prevention of 
     disease.
       (11) Seller.--The term ``seller'' means a person, company, 
     or organization that receives payment related to a medical 
     treatment of a patient of a health practitioner, except that 
     this term does not apply to a health care practitioner who 
     receives payment from an individual or representative of such 
     individual for the administration of a medical treatment to 
     such individual.

     SEC. 3. ACCESS TO MEDICAL TREATMENT.

       (a) In General.--Notwithstanding any other provision of 
     law, and except as provided in subsection (b), an individual 
     shall have the right to be treated by a health care 
     practitioner with any medical treatment (including a medical 
     treatment that is not approved, certified, or licensed by the 
     Secretary of Health and Human Services) that such individual 
     desires or the legal representative of such individual 
     authorizes if--
       (1) such practitioner has personally examined such 
     individual and agrees to treat such individual; and

[[Page S3210]]

       (2) the administration of such treatment does not violate 
     licensing laws.
       (b) Medical Treatment Requirements.--A health care 
     practitioner may provide any medical treatment to an 
     individual described in subsection (a) if--
       (1) there is no reasonable basis to conclude that the 
     medical treatment itself, when used as directed, poses an 
     unreasonable and significant risk of danger to such 
     individual;
       (2) in the case of an individual whose treatment is the 
     administration of a food, drug, or device that has to be 
     approved, certified, or licensed by the Secretary of Health 
     and Human Services, but has not been approved, certified, or 
     licensed by the Secretary of Health and Human Services--
       (A) such individual has been informed in writing that such 
     food, drug, or device has not yet been approved, certified, 
     or licensed by the Secretary of Health and Human Services for 
     use as a medical treatment of the medical condition of such 
     individual; and
       (B) prior to the administration of such treatment, the 
     practitioner has provided the patient a written statement 
     that states the following:
       ``WARNING: This food, drug, or device has not been declared 
     to be safe and effective by the Federal Government and any 
     individual who uses such food, drug, or device, does so at 
     his or her own risk.'';
       (3) such individual has been informed in writing of the 
     nature of the medical treatment, including--
       (A) the contents and methods of such treatment;
       (B) the anticipated benefits of such treatment;
       (C) any reasonably foreseeable side effects that may result 
     from such treatment;
       (D) the results of past applications of such treatment by 
     the health care practitioner and others; and
       (E) any other information necessary to fully meet the 
     requirements for informed consent of human subjects 
     prescribed by regulations issued by the Food and Drug 
     Administration;
       (4) except as provided in subsection (c), there have been 
     no advertising claims made with respect to the efficacy of 
     the medical treatment by the practitioner;
       (5) the label or labeling of a food, drug, or device that 
     is a medical treatment is not false or misleading; and
       (6) such individual--
       (A) has been provided a written statement that such 
     individual has been fully informed with respect to the 
     information described in paragraphs (1) through (4);
       (B) desires such treatment; and
       (C) signs such statement.
       (c) Claim Exceptions.--
       (1) Reporting by a practitioner.--Subsection (b)(4) shall 
     not apply to an accurate and truthful reporting by a health 
     care practitioner of the results of the practitioner's 
     administration of a medical treatment in recognized journals, 
     at seminars, conventions, or similar meetings, or to others, 
     so long as the reporting practitioner has no direct or 
     indirect financial interest in the reporting of the material 
     and has received no financial benefits of any kind from the 
     manufacturer, distributor, or other seller for such 
     reporting. Such reporting may not be used by a manufacturer, 
     distributor, or other seller to advance the sale of such 
     treatment.
       (2) Statements by a practitioner to a patient.--Subsection 
     (b)(4) shall not apply to any statement made in person by a 
     health care practitioner to an individual patient or an 
     individual prospective patient.
       (3) Dietary supplements statements.--Subsection (b)(4) 
     shall not apply to statements or claims permitted under 
     sections 403B and 403(r)(6) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 343-2 and 343(r)(6)).

     SEC. 4. REPORTING OF A DANGEROUS MEDICAL TREATMENT.

       (a) Health Care Practitioner.--If a health care 
     practitioner, after administering a medical treatment, 
     discovers that the treatment itself was a danger to the 
     individual receiving such treatment, the practitioner shall 
     immediately report to the Secretary of Health and Human 
     Services the nature of such treatment, the results of such 
     treatment, the complete protocol of such treatment, and the 
     source from which such treatment or any part thereof was 
     obtained.
       (b) Secretary.--Upon confirmation that a medical treatment 
     has proven dangerous to an individual, the Secretary of 
     Health and Human Services shall properly disseminate 
     information with respect to the danger of the medical 
     treatment.

     SEC. 5. REPORTING OF A BENEFICIAL MEDICAL TREATMENT.

       If a health care practitioner, after administering a 
     medical treatment that is not a conventional medical 
     treatment for a life-threatening medical condition or 
     conditions, discovers that such medical treatment has 
     positive effects on such condition or conditions that are 
     significantly greater than the positive effects that are 
     expected from a conventional medical treatment for the same 
     condition or conditions, the practitioner shall immediately 
     make a reporting, which is accurate and truthful, to the 
     Office of Alternative Medicine of--
       (1) the nature of such medical treatment (which is not a 
     conventional medical treatment);
       (2) the results of such treatment; and
       (3) the protocol of such treatment.

     SEC. 6. TRANSPORTATION AND PRODUCTION OF FOOD, DRUGS, 
                   DEVICES, AND OTHER EQUIPMENT.

       Notwithstanding any other provision of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 201 et seq.), a person 
     may--
       (1) introduce or deliver into interstate commerce a food, 
     drug, device, or any other equipment; and
       (2) produce a food, drug, device, or any other equipment,

     solely for use in accordance with this Act if there have been 
     no advertising claims by the manufacturer, distributor, or 
     seller.

     SEC. 7. VIOLATION OF THE CONTROLLED SUBSTANCES ACT.

       A health care practitioner, manufacturer, distributor, or 
     other seller may not violate any provision of the Controlled 
     Substances Act (21 U.S.C. 801 et seq.) in the provision of 
     medical treatment in accordance with this Act.

     SEC. 8. PENALTY.

       A health care practitioner who knowingly violates any 
     provisions under this Act shall not be covered by the 
     protections under this Act and shall be subject to all other 
     applicable laws and regulations.
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