Court Will Rehear Case on Access to Experimental Medications

The U.S. Court of Appeals for the District of Columbia on Tuesday vacated an earlier decision that would have provided terminally ill patients with expanded access to experimental medications and likely will rehear the case next summer, Dow Jones/Wall Street Journal reports (Wilde Mathews, Dow Jones/Wall Street Journal, 11/21).

In the case, the Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation in 2003 filed a lawsuit against FDA to obtain access to experimental medications for terminally ill cancer patients (AP/Houston Chronicle, 11/22).

The lawsuit asked FDA to provide a special initial approval to experimental medications that appear effective and allow their sale and distribution to terminally ill patients who have no other approved treatment options. FDA argued that programs currently exist to provide experimental medications to terminally ill patients and that increased access to such treatments would lead to unacceptable risk.

In May, a three-judge panel of the court ruled that terminally ill patients have a "right of self-preservation" and should have access to experimental medications that have not reached Phase II clinical trials. Pharmaceutical companies use Phase II trials, which involve between 20 and 80 participants, to determine the safety, but not the effectiveness, of experimental medications.

According to the 2-1 decision, which reversed the dismissal of the lawsuit by a lower court, "barring a terminally ill patient from the use of a potentially lifesaving treatment impinges on this right of self-preservation." The decision cited a 1990 Supreme Court case that established the "right to die" for terminally ill patients who refuse treatment and said the reverse also applies (Kaufman, Washington Post, 5/3).

FDA appealed the decision and asked the full court to rehear the case.

Richard Samp, chief counsel for the Washington Legal Foundation, said, "We had asked that the rehearing not be granted, but we are confident when all the judges on the court hear the facts, they will agree with the original panel's decision."

FDA spokesperson Kristen Neese in a statement said, "We believe that access to lifesaving treatments is essential but need to find the right balance between earlier access and evaluation of safety" (AP/Houston Chronicle, 11/22).