Meds Access: A Clearer Path

The U.S. Food and Drug Administration (FDA) announced Aug. 12, 2009, that it has launched a Web site to help doctors and patients apply to obtain medications that have not yet been approved by the FDA ("investigational" drugs).

The new Access to Investigational Drugs Web site offers information about "expanded access," also known as "compassionate use," of experimental medications. It includes specific instructions, phone numbers and downloadable forms.

FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for single patients or small groups of patients with similar treatment needs who don't qualify for a clinical trial (formal drug testing).

Applicants for expanded access to a drug outside a clinical trial must have a serious or life-threatening disease or condition and no satisfactory therapeutic alternatives. The manufacturer of the medication and the patient's physician must make arrangements to obtain the drug, and these arrangements must be authorized by the FDA.

Physicians may or may not be willing to manage the patient's use of an investigational drug, and pharmaceutical companies may or may not be willing to make an investigational drug available.

Additional help with access to investigational drugs can be obtained through the FDA's Office of Special Health Issues. Send e-mail to OSHI@oc.fda.gov or call (301) 827-4460 (Rockville, Md.).

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