I am the attorney who filed an amicus brief with the D.C. federal district court on March 1, 2005 challenging the use of FDA's approval of an emergency use authorization (EUA) granted under the BioShield Act (70 Fed Reg 5452-5456, Feb 2, 2005) as the basis for amending an October 27, 2004 court injunction relating to the anthrax vaccine license.  The amicus brief was filed on behalf of the National Vaccine Information Center, the National Gulf War Resource Center and the Military Vaccine Education Center.

Please find attached the amicus motion and related documents that I wish to be added to FDA Docket No. 1980N-0208.  A total of 20 PDF files are attached to this email.

While the legal arguments in the amicus brief relating to the EUA may not be germane to FDA's consideration of the anthrax vaccine license, the factual support provided in the amicus motion and supporting documents is highly relevant to both the safety and efficacy of the BioPort anthrax vaccine.

Please feel free to contact me if you have any questions relating to this comment to FDA Docket No. 1980N-0208.

This e-mail will be sent in two parts to accommodate all of the attachments.  Thank you.



Outlook File Attachment <<91306.pdf>> <<91304.pdf>> <<91301.pdf>> <<91302.pdf>> <<91309.pdf>> <<91310.pdf>> <<91312.pdf>> <<91314.pdf>>

Kenneth T. Levine, Esquire
Nelson Levine deLuca & Horst, LLC
Four Sentry Parkway, Suite 300
Blue Bell, PA  19422
(610) 862-6570
Fax: (610) 862-6501
klevine@nldhlaw.com