QUICK FIX NEEDED ON FDA REFORM BILL- PLEASE HELP!!!

John Hammell jhammell at ix.netcom.com
Wed Nov 29 16:41:49 EST 1995


Senator Kassabaum plans on introducing her seriously flawed FDA
Reform Bill on December 1. (see below for details.) Her bill would
turn vitamins into drugs, and there is a dire need to get changes
made prior to introduction. Please read my 2 page letter (below),
then either use the short one page form letter provided in order to
fax in your own objections to the Title 2 section of her bill, or
write your own letter. Its very important that you network this
info to people immediatly so that we can generate a flood of faxes
and phone calls in to Jane Williams, Kassabaum's aide, who so far
does not hear us regarding this matter. (They don't have email.) Thank
you for your
help!!!
                                             -John Hammell




John C. Hammell                                   11/22/95
Legislative Advocate
The Life Extension Foundation
Washington DC Political Office
304 Virginia Ave
Alexandria, VA 22302
Pager: 1-800-796 SEND, PIN 102-7951, 703-548-1244 Ph/FAX

The Honorable Senator Nancy Kassebaum
c/o Jane Williams, legis. asst.
FAX 202-224-3514
Phone 202-224-4774
SR-302
Washington, DC 20510

Dear Senator Kassebaum:

Attorney Jonathan Emord has analyzed your FDA Reform Bill (Food and
Drug Administrative Performance and Accountability Act of 1995) for
the American Preventive Medical Association (APMA), and Candace
Campbell of APMA has been attempting to call an unfortunate
oversight in the Title 2 Section ("The Patients Rights Regulatory
Reform Act of 1995") to your attention. LEF supports APMA towards
this end, and urges you to give serious consideration to this
matter prior to introducing anything on December 1.

Consumers of dietary supplements, the dietary supplement industry,
and alternative physicians cannot support Title 2 in its current
form. You've obviously consulted the FDA, pharmaceutical industry
and device manufacturers in drafting it-- but not US (!) Without
building a CONSENSUS, your bill will be Dead On Arrival- something
neither you, nor our members want.

Under your current bill, dietary supplements would be regulated as
drugs if they are used in the treatment of a disease. This would
force dietary supplement companies and physicians to apply for an
IND-- a prohibitively expensive and time consuming process which is
impractical for unpatentable substances. This would undermine the
basic objectives of DSHEA, which guarantees that supplements will
NOT be treated as drugs, and that consumers WILL have free access
to beneficial, natural therapies (!) 

Many alternative physicians such as Joan Priestly, M.D.,
Legislative Director of Citizens for Health, routinely employ non
FDA approved nutritional protocols in the treatment of AIDS and
Cancer (and get demonstrably better results than do their
mainstream counterparts.) Under your bill, the FDA could force both
Dr. Priestly to file IND's on her nutritional protocols, and any
vitamin company whose products she uses, to file IND's on their
products. The same holds true for the hundreds of alternative
physicians which LEF refers to thousands of people nationwide. 

To force physicans and supplement companies to file INDs would be
prohibitively expensive (supplements are non patentable), and would
involve a staggering amount of red tape. In sum, your initiative
would serve to kill badly needed medical innovation which will help
keep costs down and provide badly needed answers for suffering
people. Provide patients with informed consent- let them choose.

As a person who recovered from a life threatening illness via a
suppressed, nutritional therapy, I encourage you to cut red tape
and foster innovation: not stifle it. The cutting edge clinicians
who belong to LEF know far more about what is good for patients
than literally ANYONE at the FDA, and its not your place, or FDA's,
to interfere with the doctor/patient relationship, or to subvert
DSHEA by regulating dietary supplements as drugs.

Obviously your reform bill would give the FDA a new way to gain
much greater regulatory control over the sale and use of dietary
supplements by consumers and health care practitioners! As you
know, DSHEA generated the largest flood of phone calls,faxes, and
letters on any single issue in the history of the US Congress. The
people have clearly spoken here, and their voice must be respected.

Moreover, Title 2 of your bill, the "Patient Rights Regulatory
Reform Act of 1995" will only allow access to unapproved therapies
if the manufacturer or distributer has filed an Investigational New
Drug Application, AND-- IF the person has no comparable or
satisfactory alternative therapy; or-- IF the risk to the person
from the investigational drug or device is not greater than the
risk from the condition. 

(Presumably the determination of "risk" would be left up to the
FDA, whose bias against alternative treatments knows no bounds.)
(Consider Dr. Burzynski, who was just indicted on trumped up
charges following an unprecedented 5th Grand Jury. The FDA has
stopped at NOTHING to harrass this highly effective alternative
practitioner. Who is going to protect US from the FDA??????

You can't reform the FDA if you are going to make them our BIG
BROTHER! We therefor strongly urge you to REPLACE TITLE 2 of your
bill with sections of both the Access to Medical Treatments Act,
and the Food and Dietary Consumer Information Act (HR 1951). AMTA
has strong bipartisan support including Senators Daschle and Dole,
Congressmen De Fazio and De Lay. HR 1951 has bipartisan support in
the House. 

It is obvious here that you've drafted this Senate bill totally
without consulting Congressman Barton in the House or anyone on his
staff such as Alan Slobodin. Given the fact that they holding FDA
Oversight Hearings, we question the wisdom of this as there seems
to be no cohesiveness. Your bill is diametrically opposed to what
the House Oversight Subcommittee has discovered is needed: a dire
need to foster innovation, not create even MORE red tape. 
                                        
cc: Usenet News Groups, plus-        For Health and Freedom,     
A grass roots database
too large to list.                          John C. Hammell
****************************************************************** 
Get the form letter, (below) out to as many people as possible and
have them flood them in to Kassebaum immediately!!! She is planning
on introducing a horribly dangerous bill on Dec. 1 unless we can
get her to listen to us and change it.


FORM LETTER TO OPPOSE TITLE 2 "THE PATIENTS RIGHTS REGULATORY
REFORM ACT OF 1995" OF "THE FOOD AND DRUG ADMINISTRATIVE
PERFORMANCE AND ACCOUNTABILITY ACT OF 1995"

Name:                                  Date:
Address:
City:                      State:      Zip:

The Honorable Senator Nancy Kassebaum
c/o Jane Williams, legis. asst.
FAX 202-224-3514
Ph. 202-224-4774
SR 302 Washington, DC 20510


Dear Senator Kassebaum:

As a consumer of dietary supplements and alternative medicine and
or as an alternative medical practitioner, and or as a manufacturer
of dietary supplements, I worked VERY HARD to pass DSHEA which
guarantees that supplements will NOT be treated as drugs, and that
consumers WILL have access to beneficial natural therapies.

Attorney Jonathan Emord has analyzed your FDA Reform bill which is
scheduled to be introduced on December 1, and he tells me that
under your current bill, dietary supplements would be treated as
drugs if they are used in the treatment of disease. This would
force dietary supplement companies and alternative physicians to
apply for INDs with the FDA. This would be prohibitively expensive
and would involve huge amounts of red tape which would KILL public
access to dietary supplements and to many alternative therapies.
To insure that this does not happen, I urge you to replace Title 2
of the bill ("The Patients Rights Regulatory Reform Act of 1995")
with sections from both the Access to Medical Treatment Act, and
the Food and Dietary Consumer Information Act. AMTA has strong
bipartisan support including Senators Daschle and Dole, Congressmen
De Fazio and De Lay. HR 1951 has bipartisan support in the House. 

We feel certain that you do not intend to turn dietary supplements
into drugs, and that this must have only been an unfortunate
oversight. As you know, the people have spoken on this issue. The
drive to pass DSHEA generated an avalanche of phone calls, faxes
and letters to Congress. We need to speak with you about this prior
to the introduction of this bill in order to make the necessary
changes, otherwise, we will be forced to awaken the sleeping giant
and crush the life out of this bill to prevent it from doing harm
to the American people. Please write to let me know your intentions
on this matter.
                                             Sincerely,


(Letter prepared for my convenience by John C. Hammell, legislative
advocate, The Life Extension Foundation/DC Field Office,703-548-
1244  jhammell at ix.netcom.com PAGER 1-800-796-SEND PIN 102-7951)


-- 
 John Hammell, Political Coordinator, The Life Extension Foundation
            800-333-2553, 305-929-2905, 305-929-0507 FAX
jhammell at netcom.com  http://www.webcom.com/~lef/index.html
**For Complimentary Copy Life Extension Magazine-Send Street Address**



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