Court won't bend drug rule for dying patients

WASHINGTON — Dying people do not have the right to obtain unapproved drugs that are potentially lifesaving, even if their doctors say the treatment offers the best hope for survival, a U.S. appeals court in Washington ruled Tuesday.

In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.

Food and Drug Administration approval of drugs generally requires testing that can involve years of trials and thousands of patients.

The families of terminally ill patients, several of whom died after they were denied promising drugs still being tested, filed the lawsuit. They said dying patients were far more willing to take risks and should not be forced to wait for new treatments to win final FDA OK.

The judges said the families should take their pleas to Congress, not the courts.

Leaders of the Abigail Alliance for Better Access to Developmental Drugs said they would appeal to the Supreme Court. The group was named for Abigail Burroughs, 21, a University of Virginia student who died of cancer in 2001. Her father said she was denied two new anti-cancer drugs that were being testing and were recommended by her oncologist.

In 2003, the alliance petitioned the FDA and urged it to change its rules so drug companies could make available to dying patients "investigational drugs" that had won preliminary approval.

The FDA rejected the plea.

With the aid of the Washington Legal Foundation, a conservative nonprofit, the alliance sued the FDA.

In 2004, a federal judge rejected the alliance's lawsuit. But last year, a three-judge appeals-court panel sided with the group. In a 2-1 decision, the appeals court said a "terminally ill, mentally competent adult patient" has a right to "potentially lifesaving investigational new drugs" that have been found to be safe for humans.

Before that decision could take effect, the full U.S. Court of Appeals for the District of Columbia voted to rehear the case. Tuesday, it reversed the panel's ruling.

"We conclude there is no fundamental right ... of access to experimental drugs for the terminally ill," said Judge Thomas Griffith, an appointee of President Bush.

Griffith's opinion was joined by conservative and liberal members of the appeals court.

The two dissenters were Judge Judith Rogers, a President Clinton appointee, and Chief Judge Douglas Ginsburg, a President Reagan appointee.

"In the end, it is startling," Rogers wrote, that the Constitution has been read to include unnamed "fundamental rights" to marry, to control a child's education, to have sex in private and to have an abortion, "but the right to save one's life is left out."

Material from The Associated Press is included in this report.