FDA & Plaintiff's counsel PR.'s on FDA issuing a final rule on anthrax vaccine

[Guest guest]

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)

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 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 J. Michels, Jr., a partner in the

Chicago office of McGuire Woods LLP (www.mcguirewoods.com), who previously

represented Major Sonnie Bates and Captain 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/scripts/oc/ohrms/advdisplay.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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