Bill would allow investigational drug use

Drugs in FDA clinical trials could be used by eligible Nebraska patients under a bill heard Feb. 11 by the Health and Human Services Committee.

LB804, introduced by Omaha Sen. Robert Hilkemann, would allow an eligible patient under the Investigational Drug Use Act to be treated with any drug, biological product or medical device that has successfully completed Phase 1 of a clinical trial but has not yet been approved for general use by the FDA—provided that the drug remains in an FDA-approved clinical trial.

Hilkemann said 41 states have either approved or are considering similar legislation, which he said could give patients who are out of other options access to experimental drugs.

“This is a bill to give hope to those Nebraskans suffering from chronic and possible terminal illnesses,” he said.

To be eligible, a patient must:
• have a documented, advanced illness;
• have considered all other approved treatment options;
• give written, informed consent for the use of the investigational treatment; and
• have a recommendation from his or her treating physician for an investigational drug, biological product or device.

Under the bill, a manufacturer could provide an investigational treatment without compensation and would be prohibited from seeking reimbursement for such treatment if an eligible patient died while being treated.

In addition, a treating physician or medical institution would not be held liable under the act.

Kim Robak, testifying on behalf of the Nebraska Medical Association and the Nebraska Oncology Society, supported LB804. There are patients with serious, life-threatening diseases who are out of other options, she said.

“This bill makes some sense in those instances, to perhaps provide some alternative when no other alternative exists,” Robak said. She cautioned committee members, however, that the bill could raise unrealistic expectations.

Pharmaceutical companies ultimately would make the decision to provide access to investigational treatments, she said, and state lawmakers cannot compel them to do so.

No opposition testimony was offered and the committee took no immediate action on the bill.