this probably has more implications for the ALS board. too bad the members of this court were not part of the GDNF hearing ...though this ruling may result in major problems for both patients and doctors, could be a boon for the pharmaceutical industry--

On May 2, 2006, a three-judge panel of the D.C. Circuit Court of Appeals issued a decision in the case of Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach that poses a major challenge to the authority of the Food and Drug Administration (FDA) to regulate access to unapproved drugs still in early stages of development. By a vote of 2-1, the Court of Appeals panel found that terminally ill patients had a constitutional right to access unapproved agents after Phase I clinical trials, a holding that threatens the entire current framework of review and approval of new drugs by FDA.

Background

The Abigail Alliance represents the views of several individuals who lost family members to cancer after unsuccessfully seeking access to new agents that were in the process of clinical trials and review by FDA. In 2003, the Alliance initiated communication with FDA, seeking changes in its drug review to allow access to new drugs routinely after Phase I testing. A Citizen Petition urging such relief was filed in June 2003, and, in the absence of a response from FDA, the Abigail Alliance filed suit in federal district court, alleging that FDA’s policy denied the constitutional rights of patients to access potentially life-saving drugs. The district court dismissed the suit in October 2004, based on the failure of the plaintiffs to assert a valid constitutional right to unapproved drug therapy.

The reversal of the district court decision by the Court of Appeals and the acceptance of a previously unrecognized constitutional right to unapproved therapy was unexpected. The next day’s Washington Post editorial criticizing the decision was entitled “A Court Makes Up A Right.”

Subsequent Judicial Events

FDA filed two requests for rehearing of the Court of Appeals decision: first, to the three-judge panel that made the decision, requesting reconsideration by those three judges; second, to the entire Court of Appeals, in what is referred to as en banc review, essentially asking the full court to overturn the panel’s decision. Following the filing of a number of briefs by both parties and several months of deliberation, decisions were issued by both the three-judge panel and the full Court of Appeals on November 21. The three-judge panel once again split 2-1 in favor of the Abigail Alliance position, refusing to reconsider its earlier decision. At the same time, however, the full Court of Appeals voted to vacate the May 2 decision of the three-judge panel and to rehear the case en banc—i.e., before all the judges of the Court of Appeals. The decision of the full court to vacate the panel’s decision is a signal that there is significant dissatisfaction with the panel’s reasoning. If the Court of Appeals en banc ultimately disagrees with the panel’s decision after rehearing, then the dismissal of the Abigail Alliance complaint by the district court would stand, and, barring a successful appeal to the U.S. Supreme Court, there would be no further legal options for the Abigail Alliance.

Process and Timing

Briefing by both parties for the rehearing en banc will occur in January 2007. Anyone seeking to file an amicus brief has two options: seek consent of all parties or file a motion with the Court of Appeals seeking permission to file such a brief. If permission were granted, the brief would have to be filed sometime during January 2007.