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All other bills currently proposed on State and Federal levels including the Weldon/Maloney bill (The Madhatters Bill) are watered down and constitute a strategic compromise that inevitably fails. The Mercury-Free Drugs Act 2005 herein, is being proposed to various Congressmen and women in the 109th Congress. Please use it as a basis for your State bills.  Or contact Attorney Diane Miller at similars@aol.com for model draft of state bill. Mercury does not belong in children's bodies even in trace amounts.

Comparative analysis of  Weldon H.R. 881 and the Mercury Free Drug Act 2005 (MFDA)

Mercury-Free Drugs Act of 2005 (To Be Introduced in House [& Senate])

HR nnnn             [S nnnn]

109th CONGRESS

1st Session

H. R. nnnn             [S. nnnn]

To amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through drugs and for other purposes.

 

IN THE HOUSE OF REPRESENTATIVES  [IN THE SENATE]

Month day, 2005

___________________________________________ introduced the following bill; which was referred to the Committee on Energy and Commerce             [appropriate SENATE committee, HELP committee?]

 

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A BILL

To amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through drugs and for other purposes.

 

 

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 'Mercury-Free Drugs Act of 2005'.

 

 

SEC. 2. FINDINGS.

 

The Congress finds as follows:  

(1)     In July 1999, the Public Health Service and the American Academy of Pediatrics issued a joint statement, which was later endorsed by the American Academy of Family Physicians, proclaiming: “[The] Public Health Service, the American Academy of Pediatrics, and vaccine manufacturers agree that Thimerosal-containing vaccines should be removed as soon as possible.”  Similar conclusions were reached this year in a meeting attended by European regulatory agencies, the European vaccine manufacturers, and the United States Food and Drug Administration (FDA), which examined the use of Thimerosal-containing vaccines produced or sold in European countries.

(2)     In July 2000, the Public Health Service, the Advisory Commission on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians issued a joint statement, providing: “The AAFP, [the] AAP, and the PHS in consultation with the ACIP reaffirm the goal set in July 1999 to remove or greatly reduce Thimerosal from vaccines as soon as possible for the following reasons: 1) the removal or substantial reduction of Thimerosal from vaccines is feasible, 2) the progress in removal which has been made to date is substantial, 3) the discussions between the Food and Drug Administration and the vaccine manufacturers in removing Thimerosal are ongoing, and 4) the public concern about the use of mercury of any sort remains high.  Based on information from the FDA and manufacturers, the PHS projects that the United States will complete its transition to a secure routine pediatric vaccine supply free of Thimerosal as a preservative (i.e. at least two vaccine products each for Hep B, Hib, and DTaP) by the first quarter of 2001.”

(3)     The Institute of Medicine's Immunization Review Committee concluded that significant reasons existed for continued public health attention to concerns about Thimerosal exposure and neurodevelopmental disorders and recommended the removal of Thimerosal from vaccines administered to children and pregnant women.

(4)     Federal regulatory agencies and manufacturers have taken positive steps to remove Thimerosal from some medical products; most notably routinely administered childhood vaccines.

(5)   Considerable progress has been made in reducing mercury exposures from childhood vaccines, yet 5 years after the July 1999 statement, a preservative level of Thimerosal remains in several non-routinely administered childhood vaccines and most of the influenza vaccine that, since December 2003, has been recommended for the administration to pregnant women and young children.  In addition, rather than removing Thimerosal from their Thimerosal-preserved childhood vaccines, manufacturers have chosen rather to reduce the level of Thimerosal and misleadingly label these as “Preservative free” vaccines to conceal the continued presence of Thimerosal (organic mercury) in these reformulated vaccines.

(6)     There is no law or regulation to prohibit the reintroduction of Thimerosal or the addition of other mercury compounds into any products from which Thimerosal has been removed or mandating all added mercury compounds be removed from all other drugs; this leaves open the possibility that Thimerosal or other mercury compounds may be introduced at some point in the future or left in other mercury-containing drugs.

(7)     The Environmental Protection Agency has estimated that as many as 1 in 6 infants are born with a blood mercury level that exceeds the Agency's safety threshold.

(8)   Cumulative exposures to mercury, a neurotoxin, are known to cause harm, particularly in young children and pregnant women.

(9)     In 2004, studies have shown that Thimerosal disrupts critical neuronal developmental pathways at nanomolar levels (0.004 parts per million Thimerosal [0.002 parts per million mercury]) (Waly et al., 2004).  Animal studies have established that low-doses of injected Thimerosal produce symptoms mimicking those seen in autism (Hornig et al., 2004), and that Thimerosal injected into infant primates resulted in significant and persistent concentrations of mercury in the brain (Burbacher et al., 2004).  Human population studies have established that a significant risk factor for developing childhood neurodevelopmental disorders was the amount of mercury children received from Thimerosal-containing vaccines (Geier & Geier, 2004).  Earlier studies have shown that sub-micromolar levels of ionic mercury are toxic to growing neurons (Leong et al., 2001).

(10)   In 2004, the CDC issued an Autism A.L.A.R.M. that reports 1 child in 6 as having a developmental and/or behavioral disorder and 1 child in 166 as having autism.  Furthermore, there is now clear clinical evidence that establishes mercury as one cause of America’s current epidemic level of neurodevelopmental disorders in our children.

(11)   Recent October 2004 Congressional hearings on the Influenza Vaccine have again established that no scientifically sound toxicological studies have been conducted that address the long-term toxicological consequences of the mercury present in existing products to susceptible individuals.  Since the FDA has repeatedly admitted failing to require scientifically sound and appropriate toxicological studies and standards of purity for vaccines and certain other biologically derived drugs (e.g., monoclonal antibodies), it is incumbent upon Congress to require that such studies be done.

(12)   Taking steps to reduce mercury exposures through drugs, including vaccines, is an important way to reduce direct exposures to mercury and mercury compounds.

  SEC. 3. BANNED MERCURY-CONTAINING DRUGS, IN GENERAL.

(a) Prohibition- Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the following:

“(h)   If it is a banned mercury-containing vaccine under section 351B of the Public Health Service Act.'.

“(i)    If it is a drug, other than a vaccine, containing any amount of elemental mercury or mercury compound, then, on the grounds of safety, said drug shall be banned from introduction into interstate commerce 180 days after the effective date of this legislation unless –

“(1)   it is approved for use by the United States Food and Drug Administration, and the maximum level of mercury present is:

“(A) not more than 0.5 microgram in each dose when the drug is ONLY labeled for administration in a single-dose regimen or the drug is infrequently (not more than 3 doses per year) administered or

“(B) Not more than 0.03 microgram in each dose when the drug is ONLY labeled for use in a short-term regimen (not more than 3 doses per day for not more than “two weeks”), or

“(C) not more than 0.01 micrograms in each dose when the drug is labeled for use in the long-term dosing regimen (for chronic use) or the dosing is labeled to exceed 50 doses per month, or

“(2)      notwithstanding the limits established in paragraph (1), if it has any amount of mercury or a mercury compound added to it directly or indirectly (as a constituent in an added component) during any stage of its the manufacture unless scientifically sound and appropriate acute, chronic, and long-term toxicological studies, using 100 times the maximum releasable mercury level (when the mercury or mercury compound present is in a matrix-bound form) or the mercury level present in the finished formulation (when the mercury or mercury compound present is not bound up in a solid matrix), the same administration route as the drug, mercury-poisoning-susceptible primates in the most susceptible age range in the dosing regimen’s intended permissible age range, and male members of the primate species whose susceptibility to mercury poisoning most closely matches man, have unequivocally established (at a confidence level of not less than 95 %) that the form and level of mercury present in the drug is safe under the longest-term, highest-dose, most-frequent-dosing regimen approved for use for the administering of the drug in question, or

“(3)   It is a homeopathic drug recognized in the Homeopathic Pharmacopeia of the United States that is official on the day this legislation is enacted.”

(b) Amendment to PHSA- Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by inserting after section 351A the following:

“SEC. 351B. BANNED MERCURY-CONTAINING VACCINES.

“(a) In General- For purposes of section 501(h) of the Federal Food, Drug, and Cosmetic Act, and subject to subsection (b), a vaccine is a banned mercury-containing vaccine under this section if--

“(1)   any organic mercury compound is added at any stage in the manufacture of said vaccine without the appropriate safety studies proving that the residual level left in the vaccine is safe with a 100X safety margin;

“(2)   1 dose of the vaccine contains 1 or more micrograms of mercury in any form; or

“(3)   The vaccine contains any quantity of Thimerosal, or other organic mercury compound, that contains more than 0.5 micrograms of mercury per 0.5-mL dose and the vaccine is listed in the current version of the recommended childhood and adolescent immunization schedule of the Centers for Disease Control and Prevention.

“(b) Public Health Emergency Exception-

“(1)   Exception- Subsection (h) of section 501 of the Federal Food, Drug, and Cosmetic Act shall not apply to a vaccine during the effective period of a declaration issued by the Secretary for such vaccine under this section.

“(2)   Declaration- The Secretary may issue a declaration concluding that an actual or potential bioterrorist incident or other actual or potential public health emergency makes advisable the administration of a vaccine described in subsection (a) notwithstanding the mercury or Thimerosal content of such vaccine.

“(3)         Limitation- The Secretary--

“(A)   shall specify in any declaration under this section the beginning and ending dates of the effective period of the declaration; and

“(B)   May not specify any such effective period that exceeds 12 months.

“(4)   Renewals- At the end of the effective period of any declaration under this section, the Secretary, subject to paragraph (3), may not issue another declaration for the same incident or public health emergency.

“(5)   Publication- The Secretary shall promptly publish each declaration under this section in the Federal Register.

“(c) Effective Dates – Mercury-containing vaccines –

“(1)   In the case of a vaccine described in subsection (a)(1) of Section 351B, the amendments made by this section apply only to vaccines introduced, or delivered for introduction, into interstate commerce on or after the following:

“(A)      January 1, 2006 or 180 days after the date of enactment of this legislation, whichever is later, if the vaccine is an influenza vaccine.

“(B)   July 1, 2006 or 360 days after the date of enactment of this legislation, whichever is later, if the vaccine (other than an influenza vaccine) is listed in the January-June 2005 version of the recommended childhood and adolescent immunization schedule of the Centers for Disease Control and Prevention.

“(C)      January 1, 2007 or 540 days after the date of enactment of this legislation, whichever is later, in the case of any vaccine not described in subparagraph (A) or (B).

“(2)   In the case of a vaccine that is not described in subsection (a) (1) of Section 351B, but is described in subsections (a) (2) or (a) (3) of 351B, the amendments made by this section apply only to mercury-containing vaccines introduced, or delivered for introduction, into interstate commerce on or after January 1, 2007 or 540 days after the date of enactment of this legislation, whichever is later.”

SEC. 4. INFORMATION ON MERCURY CONTENT.

Section 2126 of the Public Health Service Act (42 U.S.C. 300aa-26) is amended by adding at the end the following:

“(e)   Mercury Content- Not later than 180 days after the date of the enactment of this subsection, the Secretary shall revise the vaccine information materials developed and disseminated under this section to ensure that, in the case of any vaccine described in subsection (a) that contains any mercury compound, the materials include--

“(1)   a statement indicating, by compound name, the presence of mercury in the vaccine;

“(2)   A statement indicating the level of mercury, expressed in parts per billion, in the vaccine;

“(3)      Information on the availability of any mercury-free or mercury-reduced alternative vaccine and instructions on how to obtain such alternative vaccine; and

“(4)      when the vaccine is preserved with Thimerosal or any other mercury compound, a “black box” warning on the secondary packaging, the package insert, and the primary container against the administration of that vaccine to a pregnant woman or child 36-months of age or below.”

Section 502 of the Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:

‘(u)    Drugs or devices for which there has been a failure or refusal to clearly disclose the mercury content in parts per billion on the labeling.

SEC. 5 SAFETY STUDIES.

For any drug, including vaccine, licensed, approved, or accepted for use in humans or animals before or after the passage of this legislation, the Secretary shall ensure that the safety of any mercury-containing drug that contains mercury at a level above 5 parts per billion has been proven in scientifically sound and appropriate long-term chronic toxicity studies using a test drug formulation containing the equivalent of 100 times the level of releasable mercury that is present in the drug administered to the developing males of the most susceptible mammalian primate species.  For the purposes of this legislation, any drug, medical device, combination (device and drug or drug and device) product or component of any such drug, device, or combination product that contains mercury in any form shall be considered a drug.”

SEC. 6. SENSE OF CONGRESS.

It is the sense of the Congress that the Director of the Centers for Disease Control and Prevention should include, in any information disseminated by the Centers to the public or to health care providers relating to the administration of any substance addressed in Sec. 5, a recommendation, as set forth in Sec. 5, against administration of any mercury-containing drug, or other substance, to a pregnant woman or child 36-months of age or below.

SEC. 7. REPORTS TO CONGRESS.

Not later than 1 year after the date of the enactment of this Act, and annually thereafter, the Commissioner of Food and Drugs shall submit a report to the Congress annually on the progress of the Commissioner in removing mercury from vaccines.

Not later than 180 days after the date of the enactment of this Act, and annually thereafter, the Commissioner of Food and Drugs shall submit a report to Congress that lists the mercury level of any and all drugs that contain any ADDED mercury compound and the projected date past which said drug will: a) cease to contain such compound, b) be proven to be safe for that level of mercury compound in said drug, or, c) be permanently banned from the US market.   

END

 
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