Seriously ill get more access to experimental drugs

Seriously ill patients will be allowed greater access to experimental drugs under new regulations approved by the U.S. Food and Drug Administration.

The change lets drugmakers give or sell experimental medicines to patients who have no other options, including in emergencies, the agency said in the rule change posted on its Web site. Patients and doctors can see a new Web site to learn about the use of experimental treatments as part of a clinical trial or outside of one, the FDA said in a statement.

The FDA has allowed tens of thousands of patients access to unapproved therapies since the 1970s, the agency said in its statement. The new regulations clarify existing programs for providing novel medicines through clinical trials and expand drug access to additional groups of patients.

"The final rules balance access to promising new therapies against the need to protect patient safety," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "Clinical trials are the most important part of the drug development process in determining whether new drugs are safe and effective."