After years of debate over how to help dying patients with no other options, the Food and Drug Administration is looking at broadening experimental drug access for patients with serious illnesses. FDA officials have said that they're trying to strike a balance between denying gravely ill patients a shot at better health and endangering the public with untested drugs. Under a new proposal, the FDA would allow pharmacos to make certain experimental drugs available to extremely sick patients who have no other treatment options. The proposal would also provide a simpler formal process for patients and small groups to participate in this program. While patients can already get access to unapproved "treatment" drugs, the process is too complex for many patients. Their other option is to participate in clinical trials, but some patients don't qualify, and end up out of luck. The new proposal, once issued, must be approved by the federal Office of Management and Budget before it can be implemented.
Get more background on the FDA proposal:
- read this piece in the Wall Street Journal (sub. req.)
- read the report from FierceBiotech