A cancer advocacy group has filed a lawsuit against the US Food and Drug Administration (FDA) in a bid to get experimental cancer drugs into the hands of patients who have exhausted approved treatments.

The Virginia-based Abigail Alliance for Better Access to Developmental Drugs—with mixed support from other advocacy groups—filed the suit on the grounds that current regulatory policies violate patient rights to privacy and liberty. The group charges that end-stage cancer patients should, in consultation with their doctors, be able to try unapproved drugs, particularly in light of the FDA's lengthy drug approval process. The agency declined to comment on the lawsuit but has 60 days to respond.

“Despite good communications with the FDA for a long time, nothing was changing,” says Frank Burroughs, the Alliance's founder. “Every day delayed is thousands of lives lost.” Burroughs named the group after his 21-year-old daughter, who died of cancer two years ago. Before her death, Abigail Burroughs tried, and failed, to get the experimental drugs Erbitux and Iressa, now touted as wonder drugs for cancer.

Alliance members say that investigational drugs are often the last hope for the terminally ill. But under FDA rules, only a fraction of patients can access them, either by participating in clinical trials or through expanded access and 'compassionate use' programs, in which pharmaceutical companies provide a small number of patients with free experimental drugs. Only 3% of all cancer patients participate in clinical trials, however.

Cancer patients in the UK face similar problems because the UK Medical Research Council's drug approval process is at least as slow as the FDA's, says Renee Watson, policy and program coordinator at the UK's government-backed National Translational Cancer Research Network. What's worse, Watson says, is that the country has no tradition of patient advocacy, so patient needs often go unheard.

The Alliance is calling for various policy changes, including allowing companies to market—on a limited basis—drugs that demonstrate safety in phase 1 and 2 trials, while also pursuing accelerated drug approvals. Only terminally ill patients who are denied a place in clinical trials and are beyond other treatments would be eligible to buy the drugs.

But critics of the plan say that in pushing for accelerated drug approvals, advocacy groups may inadvertently lower standards for drug safety and efficacy. The National Breast Cancer Coalition has also argued that early access to experimental medicines raises false hopes among patients because, on average, the FDA approves only one out of five investigational drugs.