SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.
According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.
A “special medical use” label could be used, allowing physicians to administer the drugs to those patients in most dire need, such as those with deadly or debilitating diseases who may be willing to accept the additional perils of unproven drugs, Hamburg said.
Life-saving antibiotics or obesity drugs could be candidates for the ramped-up approval process, although Hamburg did not mention any specific drugs at the meeting.