The Abigail Alliance’s petition for a writ of certiorari in The Supreme Court of the United States was denied on January 14. A writ of certiorari is a document which a losing party files with the Supreme Court asking it to review the decision of a lower court.  It includes a list of the parties, a statement of the facts of the case, the legal questions presented for review, and arguments as to why the Court should grant the writ.

The question presented was “whether terminally ill patients who lack alternative treatment options have a constitutional right to purchase unapproved investigational drugs that have not been shown to be safe or effective and that have not been authorized for treatment uses by the Food and Drug Administration.”

Industry insiders as well as many terminally ill patients believed that if Abigail Alliance had won its suit that it would wreak havoc on the drug development process and how it is regulated.

In August 2004, Judge Ricardo Urbina of the U.S. District Court for the District of Columbia granted the government’s motion to Abigail Alliance’s original lawsuit, which was filed on July 28, 2003, on the ground that the FDA policies do not violate the rights of patients. Abigail then won its suit on appeal in a 2-1 decision handed down by a three-judge appellate panel in the U.S. District Court for the District of Columbia in May 2006.

FDA then appealed in July 2006 for a re-hearing before all the judges of that court on the grounds that the May 2006 decision presented a serious threat to FDA’s ability to ensure the safety and effectiveness of prescription drugs sold in the U.S. The re-hearing was granted in November 2006 and the case was argued in March 2007 and decided in August 2007...

In that August decision, Circuit Judge Thomas Griffith wrote in the majority opinion, “This case presents the question whether the Constitution provides terminally ill patients a right of access to experimental drugs that have passed safety trials but have not proven safe and effective. The district court held there is no such right.”

Last month, in a court brief for the FDA, U.S. Solicitor General Paul D. Clement recommended that the petition for a writ of certiorari should be denied, writing at one point, “Successful clinical trials are the exception, not the rule, as ‘the great majority of drugs will ultimately provide no benefit’ … Only five percent of all cancer drugs that begin clinical testing are ultimately approved for patient use, and even among cancer drugs that successfully complete Phase 1 testing, less than a third proceed from Phase 2 to Phase 3. Thus, when investigational drugs are fully tested by the FDA's clinical trial process, the expectations regarding safety and efficacy that led the sponsor to initiate the process commonly prove to be unfounded.”

Clement went on to describe the FDA’s expanded access program as an alternative that already exists for terminally ill patients. “When other treatments are unavailing, patients may seek access to investigational drugs before the sponsor has completed the clinical trial process and the FDA has determined that the drug is safe and effective. The FDA, acting in concert with Congress, has developed a variety of mechanisms for making investigational drugs available for treatment uses during the course of ongoing clinical trials.”

Although Abigail Alliance’s case will not be heard by the Supreme Court, the organization’s efforts have gotten the FDA to attempt to clarify the agency’s policies on expanded access. In late 2006, the FDA submitted two regulatory proposals to the Office of Management and Budget (OMB) aimed at providing a clearer pathway for certain critically ill patients so that they could be considered for access to investigative drugs without enrolling in a clinical trial.

Having gone through the OMB review process, the proposed rule, titled “Expanded Access to Investigational Drugs for Treatment Use” was posted for public comment on December 14, 2006.

For a full-length report on Abigail v. Eschenbach, please refer to the September 2007 issue of The CenterWatch Monthly.