New Rules Proposed to Expand Availability of Experimental Drugs
On December 11, the FDA proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients who have no other treatment options and to clarify the costs and the circumstances under which a manufacturer can charge for an experimental drug.
Under the proposed rules, expanded access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
The proposed rules, which are open for comment for 90 days, are described in detail at http://www.fda.gov/cder/regulatory/applications/IND_PR.htm. Additional information is available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01520.html.
On December 7, the U.S. Senate confirmed the appointment of former NCI Director Dr. Andrew C. von Eschenbach as Commissioner of the U.S. Food and Drug Administration. Additional information can be found at http://www.hhs.gov/news/press/2006pres/20061207.html.
The FDA and Genentech have sent new warning letters to health care professionals about rituximab (Rituxan), a monoclonal antibody used in the treatment of a type of non-Hodgkin lymphoma (NHL). Two patients died after being treated with rituximab for systemic lupus erythematosus (SLE). The cause of death was a viral infection of the brain called progressive multifocal leukoencephalopathy (PML).
Rituximab is approved for the treatment of CD20-positive, B-cell NHL and for moderately to severely active rheumatoid arthritis when there has been inadequate response to other treatments, but it has also been prescribed off-label for other serious diseases and conditions, such as SLE. The FDA and Genentech, which manufactures rituximab, warned physicians to "maintain a high index of suspicion for the development of PML in patients under treatment with rituximab."
Additional information is available at http://www.fda.gov/medwatch/safety/2006/safety06.htm#Rituxan.