Fda's Issuance Of Final Rule Concerning

[HARDCORE]

Forwarded comment:

FDA press release follows below...interesting how the FDA Commissioner publicly spoke about the recall of Ephedra today, but did not mention this FDA regulatory action -- announced after an unexplained 18 year wait. In fact, despite this press release, FDA will not release the announced Final Rule publicly until Jan 5th. So why announce it today? So, the Govt can file an appeal of the Court's injunctive relief on Dec 31st...just wait...

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FOR IMMEDIATE RELEASE: December 30, 2003




FOR FURTHER INFORMATION CONTACT

Mark S. Zaid, Esq.

(202) 454-2809

(202) 498-0011 (cell)



John J. Michels, Jr., Esq.

(312) 750-2770




FDA'S ISSUANCE OF FINAL RULE CONCERNING

ANTHRAX VACCINE REFLECTIVE OF LEGAL GAMESMANSHIP



18 Year Delay In Issuing Final Rule Calls Into Question FDA Conduct



WASHINGTON, D.C. --



In the wake of a December 22, 2003, Court-imposed Preliminary Injunction prohibiting the government's use of the anthrax vaccine for protection against inhalation exposure without informed consent, the Food & Drug Administration (FDA) today issued a Final Rule and Order concerning the alleged safety and effectiveness of the vaccine. Relying upon a 1985 proposed rule, the FDA now claims that "the efficacy of the vaccine includes all cases of anthrax disease regardless of the route of exposure or manifestation of disease."



The Honorable Emmet G. Sullivan of the United States District Court for the District of Columbia had ruled that the vaccine "is an investigational drug and a drug being used for an unapproved purpose...Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."



"This alleged Final Rule is nothing more than after-the-fact gamesmanship to overrule the Court's findings. It appears reflective of policy duress than independent analysis given that the 1985 proposed rule has existed for nearly 20 years without FDA action", said co-counsel Mark S. Zaid, Esq. In fact, the 1985 Panel determined that "no meaningful assessment of [the vaccine's] value against inhalation anthrax is possible..." added Zaid.



The Expert Panel limited the scope of the license when it stated "this product appears to offer significant protection against cutaneous anthrax in fully immunized subjects." Zaid also noted that the DoD has not been providing its service members or civilian contractors with the full series of shots required by the FDA.



In examining the merits of the case, Judge Sullivan concluded that the "DoD's administration of the inoculation without consent of those vaccinated amounts to arbitrary action." He further opined that "the right to bodily integrity and the importance of complying with legal requirements, even in the face of requirements that may potentially be inconvenient or burdensome, are among the highest public policy concerns one could articulate."



"The FDA pronouncement is not retroactive and, at best, means that the FDA has issued a ruling that makes the vaccine properly licensed from this point forward," said co-counsel John J. Michels, Jr., of McGuire Woods LLP. "It is clear that the FDA believes that its Final Rule alters the landscape regarding how the vaccine is categorized, and therefore, all persons vaccinated to this point were inoculated with an unlicensed or investigational vaccine," added Michels.



Internal government documents, many of which were placed before the Court,

reveal a history of regulatory violations and scientific concerns regarding the DoD's

Anthrax Vaccination Immunization Program ("AVIP"). A 1994 report by the Senate

Veterans Affairs Committee concluded that the vaccine could not be expected to protect troops against airborne anthrax and should be considered experimental. In February 2000, the House of Representative's Committee on Government Reform recommended the termination of the mandatory AVIP.



"In addition, FDA regulations indicate that the investigational status of a vaccine is not determined solely by its license status. The anthrax vaccine manufacturer has a current investigational new drug application pending before the FDA for inhalation anthrax; this application places the vaccine in IND status when the vaccine is used as a preventative for inhalation anthrax," said Michels. The Court noted that vaccines and drugs may be licensed for one application and investigational for another.



The lawsuit was filed under pseudonyms on March 18, 2003, by six plaintiffs (and other similarly situated individuals) who are either members of the active duty and selected National Guardsmen components of the Armed Forces or civilian contract employees of the Defense Department. Each of the plaintiffs had been ordered to take the anthrax vaccine. The government has indicated it will shortly seek to vacate the injunction based on the FDA's Final Rule.



The plaintiffs were represented by John J. Michels, Jr., a partner in the Chicago office of McGuire Woods LLP (www.mcguirewoods.com), who previously represented Major Sonnie Bates and Captain John Buck, the highest military officers to refuse the anthrax vaccine, and Mark S. Zaid, Managing Partner of the Washington, D.C. law firm of Krieger & Zaid, PLLC, which routinely represents individuals employed within the United States Intelligence and Military communities.

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STATEMENT Media Inquiries: 301-827-6242
December 30, 2003 Consumer Inquiries: 888-INFO-FDA


FDA ISSUES FINAL RULE AND FINAL ORDER REGARDING SAFETY AND EFFICACY OF
CERTAIN LICENSED BIOLOGICAL PRODUCTS
INCLUDING ANTHRAX VACCINE

To complete the review of the safety and effectiveness of certain
bacterial vaccines and toxoids licensed before July, 1972, FDA today issued
a final rule and order that makes final determinations concerning the safety
and effectiveness of such products and amends certain biologics regulations.
The final order states FDA's conclusion that the licensed anthrax vaccine,
Anthrax Vaccine Adsorbed, is safe and effective for the prevention of
anthrax disease - regardless of the route of exposure.
The process of finalizing this rule and order has taken considerable
time, as is true with all such documents. Although a District of Columbia
Federal Court issued an injunction regarding the anthrax vaccine and its
legal status as an approved product recently, FDA made its determinations
regarding the anthrax vaccine, as reflected in the final order, long before
the court's ruling.

Expert panels were assigned the task of reviewing information on biological
products that were licensed under the Public Health Service Act before 1972
when the responsibility for licensing biological products was moved from the
National Institutes of Health to the FDA. Based upon their review of the
available data, the Expert Panel recommended that the anthrax vaccine,
originally licensed in 1970, be classified as a Category I product, meaning
that it was safe and effective as it was labeled. The panel recommended
that it continue to be licensed on the basis of the evidence of its safety
and effectiveness. These findings were originally published in the
Federal Register on December 13, 1985.
FDA agreed with the Expert Panel's general recommendation categorizing the
vaccine at that time and continues to support that conclusion in this final
rule and order.
FDA's final order states that the efficacy analysis in the controlled

clinical trial demonstrating the efficacy of the vaccine includes all cases
of anthrax disease regardless of the route of exposure or manifestation of
disease. Although there were too few inhalation anthrax
cases to support an independent statistical analysis, due to the rarity of
this method of exposure during the period
of time that the study was performed, FDA noted in the final rule that all
of the cases of inhalation anthrax that occurred were in unvaccinated
individuals. Therefore, the FDA-approved labeling for the anthrax vaccine
does not specify the route of exposure, and the vaccine is indicated for
active immunization against Bacillus anthracis, independent of the route of
exposure. (http://www.fda.gov/cber/products/biopava0131021.htm)
Also, the Institute of Medicine recently conducted an independent
review of the licensed anthrax vaccine
(http://www.nap.edu/books/0309083095/html/) and concluded that it was a safe

and effective vaccine to protect humans against anthrax, including
inhalation anthrax.
The Expert Panel that reviewed the licensed anthrax vaccine and other
bacterial vaccines and toxoids that had been licensed before 1972 also, as
part of its review, classified these products into one of the following
categories: Category I - safe, effective and not misbranded; Category II -
unsafe, ineffective or misbranded; or Category III - insufficient
information,
further testing required. The FDA focused its resources initially in
addressing those products in category II and III because these posed the
greatest potential public health harm. FDA has been working on removing
such products from the market and updating the labeling of other products
based on the Agency's determinations after the panels' recommendations.
More information about the Panel's report and FDA's conclusions regarding

the anthrax vaccine and other products under review can be found soon at
http://www.accessdata.fda.gov/script...dvdisplay.cfm.
A recent ruling by a United States District Court for the District of
Columbia gave the opinion that the anthrax vaccine should be classified as
"investigational" with regard to protecting against inhalation anthrax.
Today's final rule and order make it clear that FDA does not regard the
approved anthrax vaccine as "investigational" for protection against
inhalation anthrax. FDA's final determination of the safety and
effectiveness of the anthrax vaccine, independent of route of exposure, as
well as its conclusions regarding the Expert Panel's report,
being announced today in the final order, are relevant and
should be considered in any further litigation in this matter.
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