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ABIGAIL ALLIANCE v. VON ESCHENBACH

No. 04-5350.

445 F.3d 470 (2006)

ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS AND WASHINGTON LEGAL FOUNDATION, Appellants v. Andrew C. VON ESCHENBACH, M.D., in his official capacity as Acting Commissioner, Food and Drug Administration and Michael O. Leavitt, in his official capacity as Secretary, U.S. Dept. of Health and Human Services, Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided May 2, 2006.

Attorney(s) appearing for the Case

James S. Ballenger argued the cause for appellants. With him on the briefs were Daniel J. Popeo and David Price. Richard A. Samp entered an appearance.

Rhonda C. Fields, Assistant U.S. Attorney, argued the cause for appellee. With her on the brief were Kenneth L. Wainstein, U.S. Attorney, Michael J. Ryan, Assistant U.S. Attorney, Eric M. Blumberg, Deputy Chief Counsel, U.S. Department of Health and Human Services, and Karen E. Schifter, Associate Chief Counsel. R. Craig Lawrence, Assistant U.S. Attorney, entered an appearance.

Before: GINSBURG, Chief Judge, and ROGERS and GRIFFITH, Circuit Judges.

Opinion for the Court filed by Circuit Judge ROGERS.

Dissenting opinion filed by Circuit Judge GRIFFITH.

ROGERS, Circuit Judge.

The Abigail Alliance for Better Access to Developmental Drugs ("the Alliance") seeks to enjoin the Food and Drug Administration ("FDA") from continuing to enforce a policy barring the sale of new drugs that the FDA has determined, after Phase I trials on human beings, are sufficiently...

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