Advocacy group has win in terminally ill fight for access to experimental drugs

May 3 2006

The Washington Legal Foundation (WLF) and the advocacy group Abigail Alliance, have been successful in the U.S. Court of Appeals.

The group were contesting the Food and Drug Administration's policy to withhold early-stage experimental drugs from terminally ill patient saying it infringed upon their their right to choose.

The U.S. Court of Appeals for the district of Columbia has sided with the advocacy group which filed the suit seeking patient access to new cancer drugs before they receive FDA approval.

At present the FDA requires developing drugs to undergo a wide battery of tests, ranging from pre clinical testing in the laboratory to large, advanced trials with people. Many drug companies complain that the process can take up to 10 years.

Justice Judith Rogers, said terminally ill patients should be allowed to decide whether to accept the risks of taking a medication that might help them live longer and the key is the patient's right to make the decision about life free from government interference.

The latest ruling overturns a 2004 dismissal by the U.S. District Court for the district of Columbia, which will now have to review the case.

In its lawsuit which was entered in 2003, the alliance argues patients have the constitutional right to use any available treatment.

Under FDA regulations, the vast majority of patients with life-threatening illnesses do not have access to promising new medications during the years of clinical testing and review required by FDA.

The drugs remain unavailable even though there is evidence that they are safe and effective and even though patients have no alternative to the drugs other than to wait for their own deaths.

The FDA has taken steps to speed up the review process for drugs for cancer and other serious conditions, including granting them priority status that allows for a quicker approval decision.

Unless the FDA appeals, the case now returns to the district court, where the FDA will have an opportunity to demonstrate that it has a "compelling interest" in restricting the constitutional rights of terminally ill patients.

WLF is hopeful that it can work with the FDA to develop a new policy that takes into account the FDA's legitimate concerns while also respecting the rights of those in need of access to potentially life-saving medications.